scholarly journals Effectiveness of Modified Buzhong Yiqi Decoction In Treating Myasthenia Gravis: Study Protocol For A Series Of N-of-1 Trials

2021 ◽  
Author(s):  
Senhui Weng ◽  
Jinghao Li ◽  
Benshu Chen ◽  
Long He ◽  
Zhuotai Zhong ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Myasthenia Gravis ◽  
Western Medicine ◽  
Treg Cells ◽  
Deficiency Syndrome ◽  
Double Blind ◽  
Kidney Deficiency ◽  
Small Series

Abstract Background: Myasthenia gravis (MG) is an acquired autoimmune disease with high heterogeneity. The disease is chronic, relapsing repeatedly and progressive with acute exacerbation occasionally. Although the treatment of MG has developed, it is still unsatisfactory and has some unexpected side effects. Traditional Chinese medicine(TCM) has shown great potential in MG treatment, including relief of muscle weakness syndrome, improvement of patient’s quality of life and reduction of side effects of western medicine. The purpose of this study is to evaluate the effectiveness of Modified Buzhong Yiqi Decoction (MBYD) as an add-on therapy for MG through a small series of N-of-1 trials.Methods: Single-centre, randomized, double-blind, 3 crossover N-of-1 trials will be conducted to enroll 12 adult patients with MG diagnosed as spleen-stomach deficiency syndrome or spleen-kidney deficiency syndrome in TCM. Each N-of-1 trial has 3 cycles of two 4-week periods containing the MBYD period and placebo period. The wash-out interval of 1-week is prior to switching each period. Primary outcome: Quantitative Myasthenia Gravis (QMG). Secondary outcomes: the following scales: myasthenia gravis composite (MGC), myasthenia gravis activities of daily living profile (MG-ADL), myasthenia gravis quality of life (MG-QOL); the level of CD4+FoxP3+Treg cells and cytokines (IL-4, IL-17A, INF-γ, TGF-β) in the peripheral blood; the alterations of the composition of gut microbiota; reduction of the side effects of western medicine. Discussion: Paired t tests or Wilcoxon signed rank tests will be used to analyse this trials’ data and the results we arrived at will be interpreted cautiously. We assumed that this study would reveal that MBYD is effective for MG and provide robust evidence of the efficacy of TCM to treat MG. Trial registration: Chinese Clinical Trial Register, ID: ChiCTR2000040477, registration on 29 November 2020, http://www.chictr.org.cn/showprojen.aspx?proj=64688.

scholarly journals Effect and mechanism of YH0618 granule on chemotherapy- induced hair loss in patients with breast cancer: study protocol for a randomized, double-blind, multi-center clinical trial

2019 ◽  
Author(s):  
Jie-shu You ◽  
Li Guo ◽  
Mei Huang ◽  
Xin-lei Shi ◽  
Man-di Lin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Chinese Medicine ◽  
Hair Loss ◽  
Double Blind ◽  
Kidney Deficiency ◽  
Group A ◽  
Group B

Abstract Background: Hair loss is one of the most common side effects of chemotherapy, which can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there is no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies showed that a medicinal and edible decoction YH0618 could significantly promote hair growth in cancer patients after chemotherapy, without interfering with the anti-tumor effect of chemotherapy. Besides, the theory of Chinese Medicine believes “Essence of the kidney is reflected on the hair”. Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction. Methods/Design: Eligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contains Taxanes or/and Anthracyclines, and chemotherapy regimen will last at least 6 cycles with every three weeks a cycle. Subjects assigned to group A will receive YH0618 granules two times a day (6 g each time), 6 days a week, mixing with 300 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome is the time point of occurrence of hair loss reaching grade II assessed by WHO Toxicity Grading Scale, and objective indexes of hair quality and hair follicle recorded by a hair and scalp detector before the fifth chemotherapy. Secondary outcomes include changes of facial color and thumbnails color, grading of thumbnails ridging, assessment of quality life, fatigue, routine blood test, hepatic and renal function, and some medical indicators which can reflect kidney deficiency in Chinese Medicine. Discussion: This research is of great significance for the treatment of cancer and improving the quality of life of patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development. Trial registration: The trial was registered on 14 December 2018 at Chinese Clinical Trial Registry: ChiCTR1800020107.

scholarly journals The effect and mechanism of YH0618 granule on chemotherapy- induced hair loss in patients with breast cancer: study protocol for a randomized, double-blind, multi-center clinical trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jie-shu You ◽  
Li Guo ◽  
Mei Huang ◽  
Xin-lei Shi ◽  
Man-di Lin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Cancer Patients ◽  
Hair Loss ◽  
Double Blind ◽  
Kidney Deficiency ◽  
Group A ◽  
Group B

Abstract Background Hair loss is one of the most common side effects of chemotherapy, and can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there are no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies showed that a medicinal and edible decoction, YH0618, could significantly promote hair growth in cancer patients after chemotherapy, without interfering with the anti-tumor effects of chemotherapy. Besides, the theory of Chinese Medicine believes that the “Essence of the kidney is reflected on the hair”. Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction. Methods/design Eligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contain taxanes or/and anthracyclines, and the chemotherapy regimen will be for at least six cycles with a cycle every 3 weeks. Subjects assigned to group A will receive YH0618 granules twice a day (6 g each time), 6 days a week, mixed with 300 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome is the time point of occurrence of hair loss reaching grade II as assessed by the WHO Toxicity Grading Scale, and objective indices of hair quality and hair-follicle growth recorded by a hair and scalp detector before the fifth chemotherapy cycle. Secondary outcomes include changes of facial color and thumbnail color, grading of thumbnails ridging, assessment of quality life, level of fatigue, routine blood test results, hepatic and renal function, and certain medical indicators which can reflect kidney deficiency in Chinese Medicine. Discussion This research is of great significance for the treatment of cancer and improving the quality of life of cancer patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR1800020107. Registered on 14 December 2018.

A double-blind randomized trial of pyridoxine versus placebo for the prevention of pegylated liposomal doxorubicin hydrochloride-related palmar-plantar erythrodysesthesia

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5594-5594
Author(s):  
V. E. Von Gruenigen ◽  
H. Frasure ◽  
N. Fusco ◽  
E. Eldermire ◽  
S. Eaton ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Liposomal Doxorubicin ◽  
Assessment Tool ◽  
Pegylated Liposomal Doxorubicin ◽  
Doxorubicin Hydrochloride ◽  
Double Blind ◽  
Group A ◽  
Group B

5594 Background: To compare the efficacy of pyridoxine versus placebo in the prevention of palmar-plantar erythrodysesthesia (PPE) and on quality of life (QOL) in patients treated with pegylated liposomal doxorubicin hydrochloride for ovarian, breast, or endometrial cancer. Methods: All patients received pegylated liposomal doxorubicin hydrochloride 40 mg/m2 IV q 4 weeks over 1 hour every 28 days for a maximum of 6 cycles. Patients received pyridoxine 100 mg (group A) by mouth or placebo (group B) twice daily. Nurses conducted standard PPE education for all patients. Patients with Grade 2 or 3 PPE that persisted despite dose reductions/delays were unblinded, and were given pyridoxine if taking placebo. Patients completed the Functional Assessment of Cancer Therapy (FACT) assessment tool. Analyses were conducted by group and comparisons were also made between patients who experienced grade 2/3 PPE versus grade 0/1. Chi-square or Fisher's exact test were used. Results: Thirty-four patients were enrolled with 18 randomized to group A and 16 to group B. Mean age was 64 years (SD=9.6; range 45–81 years). Five patients (group A, 3; group B, 2) were unevaluable (due to pegylated liposomal doxorubicin hydrochloride reaction during first chemotherapy cycle). Overall 15/29 (52%) patients had incidence of PPE (all grades), with 10/29 (34%) having grade 2/3 events (no grade 4 events observed). In group A, 8/15 (53%) patients had a PPE event and 7/14 (50%) in group B; p=0.857. For grade 2/3 events, there was no difference as 6/15 (40%) occurred in group A and 4/14 (29%) in group B; p=0.70. There were no differences in global or domain QOL scores between those patients with Grade 2/3 PPE versus Grade 0/1. Less than half [4/10 (40%)] of patients with Grade 2/3 PPE reported being bothered by side effects of pegylated liposomal doxorubicin hydrochloride treatment. Conclusions: As administered in this study, pyridoxine did not prevent PPE in patients treated with pegylated liposomal doxorubicin hydrochloride. Quality of life differences were not observed; however, not all patients with PPE reported being bothered by side effects of pegylated liposomal doxorubicin hydrochloride treatment. Pyridoxine is not indicated for prevention of PPE during chemotherapy. [Table: see text] [Table: see text]

Paliperidone Palmitate and Quality of Life in Schizophrenia

2017 ◽  
Vol 41 (S1) ◽  
pp. S268-S268
Author(s):  
N.B. Juan Carlos ◽  
B. Girela ◽  
A. Maria Angeles
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Clinical Symptoms ◽  
Oral Treatment ◽  
Paranoid Schizophrenia ◽  
World Health ◽  
Paliperidone Palmitate ◽  
Double Blind ◽  
Schizophrenic Patients

There is growing interest in the study of the quality of life of mental disorders in general, and particularly in schizophrenia. The quality of life is defined by the world health organization as the perception that an individual has of his place in existence, in the context of culture and value system in which they live and in relation to its objectives, their expectations, their rules, their concerns. Paliperidone palmitate is a depot anti-psychotic treatment monthly application is indicated for maintenance treatment of schizophrenia in adult patients. In this work the quality of life in 5 subjects with a diagnosis of paranoid schizophrenia (less than 10 years of diagnosis) is evaluated, all males, aged between 42 and 45 years and with poor adherence to oral treatment. The patients received an average of paliperidone palmitate 100 mg/month. We evaluate the quality of life at baseline and after 3 months – BREF quality of life (WHOQOL – BREF) Scale Quality of Life (QOLS) and WHO was used. The results showed significant improvements in major QOLS scale in all subjects. There were no significant differences in total score WHOQL – BREF scale, but if there was improvement in the scores of some subscales. They no side effects evaluated in the UKU scale. The quality of life in schizophrenic patients can be affected by the presence of, particularly cognitive and negative clinical symptoms. New treatments as paliperidone palmitate improve adherence and have fewer side effects can improve the perceived quality of life. However, they need more extensive studies double-blind evaluation.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Study protocol: DexaDays-2, hydrocortisone for treatment of dexamethasone-induced neurobehavioral side effects in pediatric leukemia patients: a double-blind placebo controlled randomized intervention study with cross-over design

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
A. M. van Hulst ◽  
E. J. Verwaaijen ◽  
M. F. Fiocco ◽  
S. M. F. Pluijm ◽  
M. A. Grootenhuis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Lymphoblastic Leukemia ◽  
Controlled Trial ◽  
Life Questionnaire ◽  
Dexamethasone Treatment ◽  
Double Blind ◽  
Pediatric Leukemia ◽  
Double Blind Placebo

Abstract Background Dexamethasone, a highly effective drug in treating pediatric acute lymphoblastic leukemia (ALL), can induce serious neurobehavioral side effects. These side effects are experienced by patients and parents as detrimental with respect to health related quality of life (HRQoL). Based on previous studies, it has been suggested that neurobehavioral side effects are associated to cortisol depletion of the mineralocorticoid receptor in the brain. Our previously reported randomized controlled trial, the Dexadagen study (NTR3280), suggests that physiological hydrocortisone addition during dexamethasone treatment may overcome clinically relevant neurobehavioral problems in patients who experience these problems during dexamethasone treatment. With our current study, we aim to replicate these results in a targeted larger sample before further implementing this intervention into standard of care. Methods In a national center setting, pediatric ALL patients between 3 and 18 years are enrolled in an Identification study, which identifies patients with clinically relevant dexamethasone-induced neurobehavioral side effects using the Strengths and Difficulties Questionnaire (SDQ). Contributing factors, such as genetic susceptibility, dexamethasone pharmacokinetics as well as psychosocial and family factors are studied to determine their influence in the inter-patient variability for developing dexamethasone-induced neurobehavioral side effects. Patients with clinically relevant problems (i.e. a rise of ≥ 5 points on the SDQ Total Difficulties Score after 5 days of dexamethasone) are subsequently included in a randomized double-blind placebo-controlled trial with a cross-over design. They receive two courses placebo followed by two courses hydrocortisone during dexamethasone treatment, or vice versa, each time at least 16 days without study medication in between. The primary endpoint is change in SDQ score. The secondary endpoints are sleep (measured with actigraphy and the Sleep Disturbance Scale for Children) and HRQoL (Pediatric Quality of Life Questionnaire). Discussion The results of our current study may contribute to the management of future ALL patients who experience dexamethasone-induced neuropsychological problems as it may improve HRQoL for patients who suffer most from dexamethasone-induced neurobehavioral side effects. Furthermore, by investigating multiple risk factors that could be related to inter-patient variability in developing these side effects, we might be able to identify and treat patients who are at risk earlier during treatment. Trial registration Medical Ethical Committee approval number: NL62388.078.17. Affiliation: Erasmus Medical Centre. Netherlands Trial Register: NL6507 (NTR6695). Registered 5 September 2017

scholarly journals The use of Lactobacillus plantarum 299v (DSM 9843) in cancer patients receiving home enteral nutrition – study protocol for a randomized, double-blind, and placebo-controlled trial

2020 ◽  
Author(s):  
Kaźmierczak-Siedlecka Karolina ◽  
Marcin Folwarski ◽  
Karolina Skonieczna-Żydecka ◽  
Jakub Ruszkowski ◽  
Wojciech Makarewicz
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Enteral Nutrition ◽  
Cancer Patients ◽  
Lactobacillus Plantarum ◽  
Probiotic Strain ◽  
Double Blind ◽  
Home Enteral Nutrition ◽  
Enteral Formula

Abstract Background Nutritional treatment is one of the most important components of multidisciplinary anti-cancer therapy. Home enteral nutrition is considered as a safe procedure, however, it may be associated with the risk of side effects, such as nausea, vomiting, abdominal pain, and diarrhoea. It is uncertain whether diarrhoea is the result of the enteral formula administration or gut dysbiosis. One of the methods which may be used to alter the composition of gut microbiota is the administration of a probiotic strain. Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects. Therefore, the primary aim of this study is to determine the effect of Lactobacillus plantarum 299v on nutritional status of cancer patients receiving home enteral nutrition. The secondary aims are to evaluate the role of this probiotic strain in the improvement of enteral nutrition tolerance and patients’ quality of life. Methods Forty patients with cancer receiving home enteral nutrition will be enrolled in this clinical trial and randomized to receive one capsule of Lactobacillus plantarum 299v (Sanprobi IBS®) twice a day or placebo for 12 weeks in a double-blind manner. Laboratory tests (the level of albumin, total protein, transferrin, and total lymphocyte count), anthropometric parameters (body mass, the content of fat mass, muscle mass, and total body water), Nutritional Risk Screening (NRS 2002), enteral nutrition tolerance as well as quality of life will be measured. Measurements will be obtained at the baseline and after 4 and 12 weeks of treatment. Discussion The adverse events observed during administration of enteral nutrition have an negative impact on enteral formula tolerance and as a consequence patients’ quality of life. The previous studies have demonstrated that probiotics may reduce the gastrointestinal symptoms related to enteral nutrition. Thus, administration of Lactobacillus plantarum 299v may be effective in improvement of nutritional status, enteral nutrition tolerance, and quality of life of cancer patients receiving home enteral nutrition. Trial registration ClinicalTrials.gov Identifier: NCT03940768

scholarly journals Effect and mechanism of YH0618 granule on chemotherapy- induced hair loss in patients with breast cancer: study protocol for a randomized, double-blind, multi-center clinical trial

2019 ◽  
Author(s):  
Jie-shu You ◽  
Li Guo ◽  
Mei Huang ◽  
Xin-lei Shi ◽  
Man-di Lin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Chinese Medicine ◽  
Hair Loss ◽  
Double Blind ◽  
Kidney Deficiency ◽  
Group A ◽  
Group B

Abstract Background: Hair loss is the one of the most common side effects of chemotherapy, which can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there is no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies have shown that YH0618 medicinal and edible decoction could significantly promote hair growth in cancer patients after chemotherapy, and will not interfere with the anti-tumor effect of chemotherapy. Besides, the theory of Chinese Medicine believe “Essence of the kidney is reflected on the hair”. Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction. Methods/Design: Eligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contains Taxanes or/and Anthracyclines, and chemotherapy regimen will last at least 6 cycles with every three weeks a cycle. Subjects assigned to group A will receive YH0618 granules two times a day (6 g each time), 6 days a week, mixing with 200 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome end point is successful hair preservation assessed using WHO Toxicity Grading Scale (grade ≤II), and objective indexes of hair loss levels, hair density and quality recorded by a hair and scalp detector before the fifth chemotherapy. Secondary outcomes include assessment of quality life, routine blood test, hepatic and renal function, and some medical indicators which can reflect kidney deficiency in Chinese Medicine. Discussion: This research is of great significance for the treatment of cancer and improving the quality of life of patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development. Trial Registration: The trial was registered on 14 December 2018 at Chinese Clinical Trial Registry: ChiCTR1800020107. Keywords: Medicinal and edible compound prescription, YH0618 granule, chemotherapy-induced hair loss, Taxanes, Anthracyclines, Kidney deficiency and renal dysfunction, Quality of life.

scholarly journals The use of Lactobacillus plantarum 299v (DSM 9843) in cancer patients receiving home enteral nutrition – study protocol for a randomized, double-blind, and placebo-controlled trial

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Karolina Kaźmierczak-Siedlecka ◽  
Marcin Folwarski ◽  
Karolina Skonieczna-Żydecka ◽  
Jakub Ruszkowski ◽  
Wojciech Makarewicz
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Enteral Nutrition ◽  
Cancer Patients ◽  
Lactobacillus Plantarum ◽  
Probiotic Strain ◽  
Double Blind ◽  
Home Enteral Nutrition ◽  
Enteral Formula

Abstract Background Nutritional treatment is one of the most important components of multidisciplinary anti-cancer therapy. Home enteral nutrition is considered as a safe procedure, however, it may be associated with the risk of side effects, such as nausea, vomiting, abdominal pain, and diarrhoea. It is uncertain whether diarrhoea is the result of the enteral formula administration or gut dysbiosis. One of the methods which may be used to alter the composition of gut microbiota is the administration of a probiotic strain. Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects. Therefore, the primary aim of this study is to determine the effect of Lactobacillus plantarum 299v on prevention of weight loss of cancer patients receiving home enteral nutrition. The secondary aims are to evaluate the role of this probiotic strain in the improvement of nutritional status, enteral nutrition tolerance, and patients’ quality of life. Methods Forty patients with cancer receiving home enteral nutrition will be enrolled in this clinical trial and randomized to receive one capsule of Lactobacillus plantarum 299v (Sanprobi IBS®) twice a day or placebo for 12 weeks in a double-blind manner. Laboratory tests (the level of albumin, total protein, transferrin, and total lymphocyte count), anthropometric parameters (body mass, the content of fat mass, muscle mass, and total body water), Nutritional Risk Screening (NRS 2002), enteral nutrition tolerance as well as quality of life will be measured. Measurements will be obtained at the baseline and after 4 and 12 weeks of treatment. Discussion The adverse events observed during administration of enteral nutrition have an negative impact on enteral formula tolerance and as a consequence patients’ quality of life. The previous studies have demonstrated that probiotics may reduce the gastrointestinal symptoms related to enteral nutrition. Thus, administration of Lactobacillus plantarum 299v may be effective in improvement of nutritional status, enteral nutrition tolerance, and quality of life of cancer patients receiving home enteral nutrition. Trial registration ClinicalTrials.gov Identifier: NCT03940768.

scholarly journals Oxybutynin vs Placebo for Hot Flashes in Women With or Without Breast Cancer: A Randomized, Double-Blind Clinical Trial (ACCRU SC-1603)

2019 ◽  
Vol 4 (1) ◽  
Author(s):  
Roberto A Leon-Ferre ◽  
Paul J Novotny ◽  
Eric G Wolfe ◽  
Stephanie S Faubion ◽  
Kathryn J Ruddy ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Side Effects ◽  
Repeated Measures ◽  
Mixed Model ◽  
Hot Flashes ◽  
Double Blind Study ◽  
Double Blind ◽  
Double Blind Clinical Trial

Abstract Background Hot flashes (HFs) negatively affect quality of life among perimenopausal and postmenopausal women. This study investigated the efficacy of oxybutynin vs placebo in decreasing HFs. Methods In this randomized, multicenter, double-blind study, women with and without breast cancer with 28 or more HFs per week, lasting longer than 30 days, who were not candidates for estrogen-based therapy, were assigned to oral oxybutynin (2.5 mg twice a day or 5 mg twice a day) or placebo for 6 weeks. The primary endpoint was the intrapatient change from baseline in weekly HF score between each oxybutynin dose and placebo using a repeated-measures mixed model. Secondary endpoints included changes in weekly HF frequency, HF-related daily interference scale questionnaires, and self-reported symptoms. Results We enrolled 150 women. Baseline characteristics were well balanced. Mean (SD) age was 57 (8.2) years. Two-thirds (65%) were taking tamoxifen or an aromatase inhibitor. Patients on both oxybutynin doses reported greater reductions in the weekly HF score (5 mg twice a day: −16.9 [SD 15.6], 2.5 mg twice a day: −10.6 [SD 7.7]), placebo −5.7 (SD 10.2); P < .005 for both oxybutynin doses vs placebo), HF frequency (5 mg twice a day: −7.5 [SD 6.6], 2.5 mg twice a day: −4.8 [SD 3.2], placebo: −2.6 [SD 4.3]; P < .003 for both oxybutynin doses vs placebo), and improvement in most HF-related daily interference scale measures and in overall quality of life. Patients on both oxybutynin arms reported more side effects than patients on placebo, particularly dry mouth, difficulty urinating, and abdominal pain. Most side effects were grade 1 or 2. There were no differences in study discontinuation because of adverse effects. Conclusion Oxybutynin is an effective and relatively well-tolerated treatment option for women with HFs.

scholarly journals Effect and mechanism of YH0618 granule on chemotherapy- induced hair loss in patients with breast cancer: study protocol for a randomized, double-blind, multi-center clinical trial

2019 ◽  
Author(s):  
Jie-shu You ◽  
Li Guo ◽  
Mei Huang ◽  
Xin-lei Shi ◽  
Man-di Lin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Chinese Medicine ◽  
Hair Loss ◽  
Double Blind ◽  
Kidney Deficiency ◽  
Group A ◽  
Group B

Abstract Background: Hair loss is one of the most common side effects of chemotherapy, which can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there is no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies showed that a medicinal and edible decoction YH0618 could significantly promote hair growth in cancer patients after chemotherapy, without interfering with the anti-tumor effect of chemotherapy. Besides, the theory of Chinese Medicine believes “Essence of the kidney is reflected on the hair”. Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction. Methods/Design: Eligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contains Taxanes or/and Anthracyclines, and chemotherapy regimen will last at least 6 cycles with every three weeks a cycle. Subjects assigned to group A will receive YH0618 granules two times a day (6 g each time), 6 days a week, mixing with 300 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome is the time point of occurrence of hair loss reaching grade II assessed by WHO Toxicity Grading Scale, and objective indexes of hair quality and hair follicle recorded by a hair and scalp detector before the fifth chemotherapy. Secondary outcomes include changes of facial color and thumbnails color, grading of thumbnails ridging, assessment of quality life, fatigue, routine blood test, hepatic and renal function, and some medical indicators which can reflect kidney deficiency in Chinese Medicine. Discussion: This research is of great significance for the treatment of cancer and improving the quality of life of patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development. Trial registration: The trial was registered on 14 December 2018 at Chinese Clinical Trial Registry: ChiCTR1800020107.

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