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 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 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 The use of Lactobacillus plantarum 299v (DSM 9843) in patients with cancers 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 ◽  
Enteral Nutrition ◽  
Nutritional Status ◽  
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 a safe procedure, however, 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 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 may be used as a supportive therapy in patients suffering from irritable bowel syndrome and Clostridium difficile infection. 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 tolerance of enteral formula 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), tolerance of enteral nutrition 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 It is expected that the Lactobacillus plantarum 299v will provide beneficial effects, such as maintenance or improvement of nutritional status, enteral formula tolerance, and quality of life of cancer patients receiving home enteral nutrition. Trial registration ClinicalTrials.gov Identifier: NCT03940768

scholarly journals Effects of 4 weeks of Lactobacillus plantarum 299v supplementation on nutritional status, enteral nutrition tolerance, and quality of life in cancer patients receiving home enteral nutrition – a double-blind, randomized, and placebo-controlled trial

2020 ◽  
Author(s):  
Kaźmierczak-Siedlecka Karolina ◽  
Marcin Folwarski ◽  
Jakub Ruszkowski ◽  
Karolina Skonieczna-Żydecka ◽  
Waldemar Szafrański ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Enteral Nutrition ◽  
Nutritional Status ◽  
Cancer Patients ◽  
Lactobacillus Plantarum ◽  
Gastrointestinal Symptoms ◽  
Controlled Study ◽  
Double Blind ◽  
Home Enteral Nutrition

Abstract BackgroundSeveral human trials have confirmed that Lactobacillus plantarum 299v (Lp299v) relief the gastrointestinal symptoms observed in patients with irritable bowel syndrome, such as nausea, vomiting, and diarrhoea. These symptoms are similar to those associated with home enteral nutrition and they affect nutritional status as well as patients’ quality of life.MethodsThe current double-blind, randomized, and placebo-controlled study included 35 cancer patients receiving home enteral nutrition. There were 2 groups of participants consuming either 2 × 1010 CFU of Lp299v (n = 21) or placebo (n = 14) for 4 weeks. The aims of this study were to determine the effect of Lp299v on nutritional status, enteral formula tolerance, and quality of life in cancer patients.ResultsAn increase in serum albumin concentration was significantly higher in the Lp299v group than in the placebo group at the endpoint (p = 0.032). Moreover, the changes in the frequency of vomiting and flatulence were significantly reduced at week 4 compared to baseline in the Lp299v group (p = 0.0117). The improvement of quality of life was observed in both groups; however, with no statistically significant differences between the analysed groups (p > 0.05).ConclusionsWe have demonstrated that administration of Lp299v in cancer patients receiving home enteral nutrition may improve laboratory parameters, predominantly the concentration of albumin, however, overall it does not have an impact on nutritional status. Lp299v may reduce the gastrointestinal symptoms related to enteral nutrition; notwithstanding, the improvement of quality of life may be the result of enteral nutrition rather than the effect of administration of Lp299v.Trial registration ClinicalTrials.gov (identifier: NCT03940768)

scholarly journals The impact of hyperbaric oxygen therapy on late radiation toxicity and quality of life in breast cancer patients

2021 ◽  
Author(s):  
Marilot C. T. Batenburg ◽  
Wies Maarse ◽  
Femke van der Leij ◽  
Inge O. Baas ◽  
Onno Boonstra ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Side Effects ◽  
Cancer Patients ◽  
Oxygen Therapy ◽  
Radiation Toxicity ◽  
Breast Pain ◽  
Breast Cancer Patients

Abstract Purpose To evaluate symptoms of late radiation toxicity, side effects, and quality of life in breast cancer patients treated with hyperbaric oxygen therapy (HBOT). Methods For this cohort study breast cancer patients treated with HBOT in 5 Dutch facilities were eligible for inclusion. Breast cancer patients with late radiation toxicity treated with ≥ 20 HBOT sessions from 2015 to 2019 were included. Breast and arm symptoms, pain, and quality of life were assessed by means of the EORTC QLQ-C30 and -BR23 before, immediately after, and 3 months after HBOT on a scale of 0–100. Determinants associated with persistent breast pain after HBOT were assessed. Results 1005/1280 patients were included for analysis. Pain scores decreased significantly from 43.4 before HBOT to 29.7 after 3 months (p < 0.001). Breast symptoms decreased significantly from 44.6 at baseline to 28.9 at 3 months follow-up (p < 0.001) and arm symptoms decreased significantly from 38.2 at baseline to 27.4 at 3 months follow-up (p < 0.001). All quality of life domains improved at the end of HBOT and after 3 months follow-up in comparison to baseline scores. Most prevalent side effects of HBOT were myopia (any grade, n = 576, 57.3%) and mild barotrauma (n = 179, 17.8%). Moderate/severe side effects were reported in 3.2% (n = 32) of the patients. Active smoking during HBOT and shorter time (i.e., median 17.5 vs. 22.0 months) since radiotherapy were associated with persistent breast pain after HBOT. Conclusion Breast cancer patients with late radiation toxicity reported reduced pain, breast and arm symptoms, and improved quality of life following treatment with HBOT.

scholarly journals Role of Oxycodone Hydrochloride in Treating Radiotherapy-Related Pain

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Yinxia Wang ◽  
Ligang Xing
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Cancer Pain ◽  
Cancer Patients ◽  
Pain Control ◽  
Analgesic Drugs ◽  
Oxycodone Hydrochloride ◽  
Radiation Esophagitis

Radiotherapy is commonly used to treat cancer patients. Besides the curable effect, radiotherapy also could relieve the pain of cancer patients. However, cancer pain is gradually alleviated about two weeks after radiotherapy. In addition, cancer patients who receive radiotherapy may also suffer from pain flare or radiotherapy-induced side effects such as radiation esophagitis, enteritis, and mucositis. Pain control is reported to be inadequate during the whole course of radiotherapy (before, during, and after radiotherapy), and quality of life is seriously affected. Hence, radiotherapy is suggested to be combined with analgesic drugs in clinical guidelines. Previous studies have shown that radiotherapy combined with oxycodone hydrochloride can effectively alleviate cancer pain. In this review, we firstly presented the necessity of analgesia during the whole course of radiotherapy. We also sketched the role of oxycodone hydrochloride in radiotherapy of bone metastases and radiotherapy-induced oral mucositis. Finally, we concluded that oxycodone hydrochloride shows good efficacy and tolerance and could be used for pain management before, during, and after radiotherapy.

Young-onset colorectal cancer treatment side effects: Infertility, sexual dysfunction, and quality-of-life outcomes.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3587-3587
Author(s):  
Laura Diane Porter ◽  
Ronit Yarden ◽  
Kim Lynn Newcomer ◽  
Negeen Fathi ◽  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Side Effects ◽  
Sexual Dysfunction ◽  
Cancer Patients ◽  
Fertility Preservation ◽  
Cancer Treatments ◽  
Young Onset

3587 Background: Colorectal cancer is the third-most commonly diagnosed cancer and the second-leading cause of cancer death in men and women combined in the United States. Young-onset colorectal cancer refers to individuals diagnosed under the age of 50. In recent years, the incidence has increased by 2.2% annually in individuals younger than 50 years and 1% in individuals 50-64, in contrast to a 3.3% decrease in adults 65 years and older. Young-onset (YO) CRC patients and survivors face unique clinical challenges with fertility and sexual dysfunctions, but this risk is not well quantified. There is limited data and public discussion on the long-term effects of colorectal cancer treatments on fertility and sexual dysfunction and the long-term impact on the quality of life. Methods: To explore the unique challenges and unmet needs of the young-adult patient population, a cross-sectional study was conducted. Colorectal cancer patients and survivors (N = 884) diagnosed between the ages of 20 to 50 years old (median age 42 ± 7.0) completed an online questionnaire based on established instruments EORTC-QOL-30, EORTC-CR-29, and EORTC-SHC-22. Results: Thirty-one percent of respondents stated that a medical professional spoke to them about fertility preservation at the time of diagnosis and during treatment. Only 31% were referred to a reproductive endocrinologist, even though 37% of women and 16% of men reported that treatment left them infertile or sterile. Among survey respondents, 12% of women had an egg retrieval procedure, and 36% of men had their sperm preserved prior to the start of treatment. Fifty-three percent of women reported treatment led to premature menopause. Sixty-five percent of respondents suffer from some level of sexual dysfunction due to treatment. In patients who received radiation therapy, women were 12% less likely than men to have discussed sexual side effects with the provider before treatment. Patients who have an ostomy reported more severe sexual dysfunction (17.8%). Rectal cancer patients were 2.5 times more likely than those with colon cancer to report severe dysfunction after their treatment. More than 25% of the respondents said they would have considered alternative treatment if they would have known the risks of sexual dysfunction. Conclusions: Our survey demonstrates inadequate communications between patients and providers about the irreversible fertility and sexual effects of colorectal cancer treatments. Younger patients and survivors face unique long-term challenges and require further information about fertility preservation options and emotional support regarding their sexuality post-treatment. Other studies are needed to assess the physical and psychological side effects endured by young-onset CRC patients and survivors.

Amitriptyline in Neuropathic Cancer Pain in Patients on Morphine Therapy: A Randomized Placebo-controlled, Double-blind Crossover Study

2002 ◽  
Vol 88 (3) ◽  
pp. 239-242 ◽  
Author(s):  
Sebastiano Mercadante ◽  
Edoardo Arcuri ◽  
Walter Tirelli ◽  
Patrizia Villari ◽  
Alessandra Casuccio
Keyword(s):  
Quality Of Life ◽  
Neuropathic Pain ◽  
Adverse Effects ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Cancer Patients ◽  
Double Blind ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

Aims and Background Amitriptyline is the most common analgesic adjuvant used in cancer patients with neuropathic pain, even though no specific studies have demonstrated a benefit. A randomized placebo-controlled, double-blind crossover study was designed to evidence the effects of amitriptyline in patients with neuropathic cancer pain. Methods Sixteen advanced cancer patients with neuropathic pain on systemic morphine therapy, no longer receiving oncologic treatment, presenting moderate pain (about 4 or more, but less than 7, on a numerical scale of 0-10) in the last week, and given a stable morphine dose in the last 2 days were admitted to the study. During the first week of study, patients were administered 25 mg of amitriptyline or equivalent drops of placebo at night for 3 days and 50 mg for the following 4 days. Doses for patients aged more than 65 years were 15 mg (first 3 days) and 30 mg (3 days after). After a week, a crossover took place for the second week, with the other treatment at an inverse sequence. Opioid consumption, pain intensity, symptoms and adverse effects, mood, sleep, patient's preference, quality of life before starting the study, the first week after and the second week after were recorded. Results No significant benefits in analgesia were found in the global pain intensity of the previous week of treatment, the least pain intensity or the pain evaluated just after a week of treatment, at the moment of the visit, when amitriptyline was compared with placebo. A significant difference was evidenced for the worst pain (P < 0.035). No differences in opioid doses during the period of study were found. Drowsiness, confusion and dry mouth were significantly more intense with amitriptyline than with placebo (P < 0.036, 0.003, and 0.034, respectively). There were no substantial differences between the two treatments in Spitzer's quality of life score and for each item. No differences in patients' preference for the two treatment periods were found. The analgesic effects of amitriptyline were slight and associated with adverse effects. Conclusions In light of the results obtained in the study, the extensive use of the drug for cancer pain should be questioned.

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