The Preventive Effects of Boron-Based Gel on Radiation Dermatitis in Patients Being Treated for Breast Cancer: A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2022 ◽  
pp. 1-8
Author(s):  
Fikrettin Sahin ◽  
Mohammad Bagher Pirouzpanah ◽  
Hossein Bijanpour ◽  
Mohammad Mohammadzadeh ◽  
Reza Eghdam Zamiri ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Placebo Group ◽  
Intervention Group ◽  
Phase Iii ◽  
Radiation Dermatitis ◽  
Placebo Control ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Moist Desquamation

<b><i>Introduction:</i></b> Radiation dermatitis (RD) is a side effect of radiation therapy (RT) which is experienced by over 90% of patients being treated for breast cancer. The current clinical trial was conducted to measure the preventative effects of a boron-based gel on several different clinical outcomes (dermatitis, erythema, dry desquamation, and moist desquamation) after 25 radiotherapy sessions. <b><i>Methods:</i></b> This research used a double-blind parallel-group design with a placebo control (<i>n</i> = 76) and randomized group (<i>n</i> = 181), with all participants being between 18 and 75 years old. Fifteen minutes before each radiotherapy, participants in the intervention group were given a gel containing 3% sodium pentaborate pentahydrate, while those in the placebo group received a gel with no chemical substance. Dermatitis, erythema, dry desquamation, and moist desquamation were compared between the 2 groups. <b><i>Results:</i></b> At baseline, there were no significant differences between the groups (<i>p</i> &#x3e; 0.05), except for body mass index. After 14 days of treatment, dermatitis (98.7% vs. 9.9%; <i>p</i> &#x3c; 0.001), erythema (96.1% vs. 12.2%; <i>p</i> &#x3c; 0.001), dry desquamation (50% vs. 3.9%; <i>p</i> &#x3c; 0.001), and moist desquamation (18.4% vs. 0.6%; <i>p</i> &#x3c; 0.001) were much more common in the placebo group than the intervention group. To prevent dermatitis, erythema, dry desquamation, and moist desquamation in 1 patient, on average, 1.1 (95% confidence interval [CI]: 1.1–1.2), 1.2 (95% CI: 1.1–1.3), 2.2 (95% CI: 1.7–2.9), and 5.6 (95% CI: 3.8–11.0) patients need to be treated, respectively. <b><i>Conclusion:</i></b> The boron-based gel has a significant preventive effect on several categories of RD which might be used by clinicians in breast cancer.

scholarly journals Curcumin for Radiation Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Thirty Breast Cancer Patients

2013 ◽  
Vol 180 (1) ◽  
pp. 34-43 ◽  
Author(s):  
Julie L. Ryan ◽  
Charles E. Heckler ◽  
Marilyn Ling ◽  
Alan Katz ◽  
Jacqueline P. Williams ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Cancer Patients ◽  
Radiation Dermatitis ◽  
Controlled Clinical Trial ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Double Blind Placebo

Curcumin for radiation dermatitis: A randomized, double-blind, placebo-controlled clinical trial of 30 breast cancer patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9027-9027
Author(s):  
Julie L. Ryan ◽  
Charles E Heckler ◽  
Marilyn N Ling ◽  
Jacqueline P Williams ◽  
Alice P Pentland ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Radiation Therapy ◽  
Cancer Patients ◽  
Radiation Dermatitis ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Cancer Support ◽  
Moist Desquamation

9027 Background: Radiation dermatitis occurs in approximately 95% of patients receiving radiation therapy for cancer and often leads to pain and treatment delays. There is no standard treatment with demonstrated effectiveness for the prevention of radiation dermatitis. We conducted a randomized, double-blind, placebo-control clinical trial to assess the efficacy of curcumin, a potent antioxidant and anti-inflammatory component of turmeric, to reduce radiation dermatitis in 30 breast cancer patients. Methods: Eligible patients included adult females with non-inflammatory breast cancer or carcinoma in situ prescribed radiation therapy without concurrent chemotherapy. After randomization, patients took four 500 mg capsules of curcumin or placebo three times daily throughout their course of radiation therapy (total daily dose = 6.0 g). Weekly assessments included Radiation Dermatitis Severity (RDS) Score, presence/absence of moist desquamation, erythema measure, and McGill Pain and Symptom Inventory (SI) questionnaires. Results: The 30 evaluable patients were white (90%; mean age = 58.1 years) with ER+PR+ breast cancer (76.7%) who did not have total mastectomy (90%) or chemotherapy prior to start of radiation therapy (56.7%). No significant differences were observed between arms for demographics, compliance, erythema, pain, symptoms, or radiation skin dose. Standard pooled variances t-test showed that curcumin reduced RDS at end of treatment compared to placebo (mean RDS = 2.6 vs 3.4; p=0.008). Fisher’s exact test showed that curcumin significantly reduced the presence of moist desquamation at the end of radiation therapy (28.6% vs. 87.5 %; p=0.002). Repeated measures analysis confirmed divergence of RDS between curcumin and placebo arms at Week 5. Conclusions: Oral curcumin, 6.0 g daily during radiation therapy, reduced radiation dermatitis severity and moist desquamation in breast cancer patients. A multisite CCOP trial (N=700) is underway to confirm the effectiveness of curcumin to reduce radiation dermatitis severity during various radiation therapy regimens for breast cancer. Support: IND 75,444, Dermatology Foundation, KL2 RR024136, NCI PHS 1R25CA10618.

scholarly journals Efficacy of transdermal delivery of liposomal micronutrients through body oil massage on neurodevelopmental and micronutrient deficiency status in infants: results of a randomized placebo-controlled clinical trial

BMC Nutrition ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Aditi Apte ◽  
Mudra Kapoor ◽  
Sadanand Naik ◽  
Himangi Lubree ◽  
Pooja Khamkar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Placebo Group ◽  
Motor Development ◽  
Transferrin Saturation ◽  
Intervention Group ◽  
Micronutrient Deficiency ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Moderate Anemia

Abstract Background Micronutrient deficiency is a known cause of adverse neurodevelopment and growth. Poor adherence to oral regimes of micronutrient supplements is a known challenge during the implementation of supplementation programs. The present study evaluates the benefits of liposomal encapsulated micronutrient fortified body oils (LMF oil) that can be used for infant body massage in terms of neurodevelopment and prevention of deficiency. Study design Double-blind randomized clinical trial. Methods A total of 444 healthy infants aged 4-7 weeks were randomized to receive either LMF oil (containing iron, vitamin D, folate, and vitamin B12) or placebo oil for gentle body massage till 12 months of age. Blood samples were collected at 6 and 12 months for transferrin saturation (TSAT), hemoglobin, and 25-hydroxy vitamin (25-OH-D) levels. Mental and motor development was assessed at 12 months using developmental assessment for Indian Infants (DASII). Results A total of 391 infants completed the study. There was no significant improvement in the hemoglobin in the intervention group at 12 months of age as compared to the placebo group [− 0.50 vs.-0.54 g%]. There was a marginally significant improvement in 25-OH-D at 12 months in the LMF oil group [+ 1.46vs.-0.18 ng/ml, p = 0.049]. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age [adjusted mean change + 0.11vs.-0.51 g%, p = 0.043]. The mental or motor developmental quotients in the intervention group were not significantly different from those in the placebo group. Conclusion Use of LMF oil for prevention of nutritional deficiency did not offer significant protection against nutritional anemia but prevented vitamin D deficiency to some extent with improvement in 25-OH-D at 12 months. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age. The intervention did not result in significant improvement in mental or motor development. Further evaluation with increased doses needs to be undertaken. Trial registration CTRI no: CTRI/2017/11/010710; dated 30/11/2017.

scholarly journals Title: Efficacy of transdermal delivery of liposomal micronutrients through body oil massage on neurodevelopmental and micronutrient deficiency status in infants: Results of a randomized placebo controlled clinical trial 

2021 ◽  
Author(s):  
Aditi Apte ◽  
Mudra Kapoor ◽  
Sadanand Naik ◽  
Himangi Lubree ◽  
Pooja Khamkar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Placebo Group ◽  
Motor Development ◽  
Transferrin Saturation ◽  
Intervention Group ◽  
Micronutrient Deficiency ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Moderate Anemia

Abstract Background: Micronutrient deficiency is a known cause of adverse neurodevelopment and growth. Poor adherence to oral regimes of micronutrient supplements is a known challenge during the implementation of supplementation programs. The present study evaluates the benefits of liposomal encapsulated micronutrient fortified body oils (LMF oil) that can be used for infant body massage in terms of neurodevelopment and prevention of deficiency. Study design: Double-blind randomized clinical trial Methods: 444 healthy infants aged 4-7weeks were randomized to receive either LMF oil (containing iron, vitamin D, folate, and vitamin B12) or placebo oil for gentle body massage till 12months of age. Blood samples were collected at 6 and 12 months for transferrin saturation (TSAT), hemoglobin, and 25-hydroxy vitamin (25-OH-D) levels. Mental and motor development was assessed at 12 months using developmental assessment for Indian Infants (DASII). Results: A total of 391 infants completed the study. There was no significant improvement in the hemoglobin in the intervention group at 12 months of age as compared to the placebo group [-0.50 vs.-0.54 gm%]. There was a marginally significant improvement in 25-OH-D at 12 months in the LMF oil group [+1.46vs.-0.18ng/ml, p=0.049]. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age [adjusted mean change +0.11vs.-0.51gm%, p=0.043]. The mental or motor developmental quotients in the intervention group were not significantly different from those in the placebo group. Conclusion: Use of LMF oil for prevention of nutritional deficiency did not offer significant protection against nutritional anemia but prevented vitamin D deficiency to some extent with improvement in 25-OH-D at 12 months. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age. The intervention did not result in significant improvement in mental or motor development. Further evaluation with increased doses needs to be undertaken.Trial registration: CTRI no: CTRI/2017/11/010710; dated 30/11/2017 [http://ctri.nic.in/Clinicaltrials/advancesearchmain.php ]

NSABP B-59/GBG 96-GeparDouze: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy (NAC) with atezolizumab or placebo in patients (pts) with triple-negative breast cancer (TNBC) followed by adjuvant atezolizumab or placebo.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS605-TPS605
Author(s):  
Charles E. Geyer ◽  
Sibylle Loibl ◽  
Priya Rastogi ◽  
Sabine Seiler ◽  
Joseph P. Costantino ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Neoadjuvant Chemotherapy ◽  
Residual Disease ◽  
Disease Free Survival ◽  
Placebo Control Trial ◽  
Phase Iii ◽  
Placebo Control ◽  
Double Blind ◽  
Free Survival

TPS605 Background: TNBC is associated with higher percentages of pathological complete response (pCR) to neoadjuvant chemotherapy (NAC), and women with a pCR have a favorable prognosis. However, Liedtke (2008) and Loibl (2017) found that women with residual disease have a substantially higher risk of recurrence than women with other subtypes of breast cancer. Additionally, Adams (2017) and Schmid (2017) found that therapeutic blockade of PD-L1 binding by atezolizumab has resulted in relevant anti-tumor efficacy. Methods: Design: This is a phase III, double blind, placebo-control trial evaluating neoadjuvant atezolizumab with NAC followed by adjuvant atezolizumab in TNBC. Pts are stratified by region (North America; Europe), tumor size (1.1-3.0cm; >3.0cm), AC/EC schedule (q2w; q3w), nodal status (positive; negative), and PD-L1 status (positive; negative or indeterminate) then randomized 1:1 to receive atezolizumab/placebo 1200 mg IV every 3 wks concurrently with both sequential regimens of weekly paclitaxel 80 mg/m2 IV for 12 doses with every 3-wk carboplatin AUC of 5 IV for 4 doses followed by AC/EC every 2-3 wks (per investigator discretion) for 4 cycles. Following surgery, pts resume atezolizumab/placebo 1200 mg IV every 3 wks as adjuvant therapy for 6 months. Radiotherapy based on local standards is co-administered with atezolizumab/placebo. Eligibility criteria: Centrally confirmed ER-neg, PR-neg, HER2-neg invasive breast cancer by ASCO/CAP guidelines. Primary tumor must be stage T2 or T3 if cN0 or cN1 with negative biopsy or T1c, T2, or T3 if cN1 with positive biopsy or cN2 or cN3. LVEF >55% and no significant cardiac history. Statistical methods: Co-primary endpoints are event-free survival (EFS) and pCR breast/nodes. Secondary endpoints include pCR breast, overall survival, distant disease-free survival, safety and toxicity. Trial is an academic collaboration between NSABP and GBG with support from Genentech/Roche. Support: Genentech/Roche. Clinical trial information: NCT03281954.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Effect of hand reflexology on anxiety and physiological variables among patients hospitalized in the cardiac care unit: A randomized placebo controlled clinical trial

2017 ◽  
Vol 8 (4) ◽  
pp. 35 ◽  
Author(s):  
Zohre Rahmani ◽  
Nahid Rejeh ◽  
Majideh Heravi-Karimooi ◽  
Seyed Davood Tadrisi ◽  
Mojtaba Vaismoradi
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Intervention Group ◽  
Anxiety Level ◽  
Cardiac Care ◽  
Controlled Clinical Trial ◽  
Female Patients ◽  
Coronary Syndrome ◽  
Physiological Variables ◽  
Cardiac Care Unit

Background and objective: Admission to the cardiac care unit may cause physiological and psychological problems in patients. This study aimed to investigate the effect of hand reflexology on anxiety and physiological variables among female patients with acute coronary syndrome hospitalized in the cardiac care unit.Methods: This randomized placebo controlled clinical trial was conducted on 90 female patients hospitalized in the cardiac care unit in an urban area of Iran. The patients were chosen using a convenient sampling method and then were randomly assigned into intervention (n = 45) and placebo (n = 45) groups. While the intervention group received hand reflexology for 20 minutes, the placebo group received a simple touch of hand without the stimulation of reflexology points.  Demographic data was collected at the beginning of the study using face-to-face interviews with the patients. The anxiety level was assessed using the Spielberger’s State-Trait Anxiety Inventory (STAI) immediately after the intervention and 30 min after the intervention. Also, physiological variables including respiratory rate, heart rate, blood pressure and oxygen saturation were measured before, immediately after the intervention and 30 minutes after the intervention. Descriptive and inferential statistics were used for data analysis.Results: There was no statistically significant difference between the intervention and placebo groups before the intervention (p > .05). The anxiety level in the intervention group was significantly lower than that of the placebo group immediately after the intervention and 30 minutes after the intervention (p < .05, η = 0.090). However, no statistically significant differences in physiological variables between the groups were observed (p > .05).Conclusions: Hand reflexology influenced the level of anxiety. Therefore, nurses can use hand reflexology as a method for reducing patients’ anxiety along with other nursing interventions.

scholarly journals Effectiveness and safety of Chinese herbal medicine xuanbi antong granules for the treatment of borderline coronary lesions: study protocol for a randomised, double-blinded, placebo-controlled, multicentre clinical trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e024968 ◽  
Author(s):  
Mingyan Huang ◽  
Guang Chen ◽  
Qingya Guan ◽  
Chao Liu ◽  
Qing Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Clinical Symptoms ◽  
Early Stage ◽  
Intervention Group ◽  
Blood Lipid ◽  
Controlled Clinical Trial ◽  
Cardiac Events ◽  
Coronary Syndrome ◽  
Double Blinded

IntroductionAs the early stage of coronary heart disease (CHD), borderline coronary lesion (BCL) is defined as a 30%–70% diameter stenosis. Previous studies have demonstrated that BCL may progress to acute coronary syndrome easily. However, routine medications available for the treatments of BCL have some limitations. Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years. Previous studies have shown that XAG has effectiveness in improving clinical symptoms and quality of life in patients with CHD. This study aims to evaluate the effectiveness and safety of XAG in patients with BCL.Methods and analysisThis is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. A total of 300 participants will be randomly assigned to the intervention group and the placebo group. Based on routine medications, the intervention group will be treated with XAG and the placebo group will be treated with XAG placebo. All participants will receive a 6-month treatment and then be followed-up for another 6 months. The primary outcomes are the changes of target plaque characteristics (including target plaque volume, degree of stenosis, CT value and calcification score) measured by dual source CT angiography. The secondary outcomes include blood lipid indicators, efficacy of angina symptoms, Seattle Angina Questionnaire, high-sensitivity C-reactive protein and occurrence of major adverse cardiac events. All the data will be recorded in electronic case report forms and analysed by SPSS V.20.0.Ethics and disseminationThis study has been approved by Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2017–083-KY-01). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registration numberChiCTR-IOR-17013189; Pre-results.

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