A prospective, randomized, open label study to evaluate safety and efficacy of BugSpeaks®, a microbiota based personalised diet on the quality of life of patients undergoing concurrent chemo-radiotherapy for Carcinoma Cervix of squamous histology.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To study the effects of microbiota based personalised diet on quality-of-life parameters of cervical cancer patients undergoing chemo and radiotherapy.
研究概览
简要总结
Malnutrition and muscle wasting are frequently reported in cancer patients, either linked to the tumour itself or caused by oncologic therapies. Understanding the value of nutritional care during cancer treatment remains crucial. In fact, cancer-associated sarcopenia plays a key role in determining higher rates of morbidity, mortality, treatment induced toxicities, prolonged hospitalizations and reduced adherence to anti cancer treatment, worsening quality of life and survival. Since many cancer patients suffer weight loss and are poorly nourished or initially sarcopenic, the importance of screening patients for malnutrition from the beginning of their treatment is well established, as lack of proper nutritional management may limit the response to even the most effective therapy.
More especially, muscle wasting, resulting from mechanical and functional disorders including the imbalance between catabolic and anabolic pathways, is associated with increased surgical complications, poor prognosis, greater treatment related toxicities, a poorer response to anti-cancer therapies, worse quality of life and length hospital stay, On the other hand, cancer therapies may affect the function and composition of gut microbiota, and can trigger dysbiosis affecting multiple metabolic pathways, thus weakening the immune response [6]. We will outline the role of gut microbiota in cancer therapies in terms of toxicity and treatment response and, in turn, how cancer therapies could impact gut microbiota composition and function and vice versa. In this context, we will explore the potential implications of personalized nutritional interventions based on the gut microbiota profile during cancer therapies [7-10]. In this study, we will ascertain how modulating the gut microbiota through nutritional intervention may improve the overall quality of life of the cancer patients and may also improve the efficacy of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Cervical Cancer(Of Squamous Histology) Stage III and IV, Undergoing chemoradiotherapy.
- •Signed Informed Consent Form.
- •Patients who agrees to follow personalised diet for 3 months.
- •Karnofsky Performance Score Greater than 70.
排除标准
- •Individuals with Gastritis, Colitis, Irritable Bowel Syndrome, Pseudomembranous Colitis and Crohns disease.
- •Individuals with autoimmune diseases and or under treatment with corticosteroids and or immunosuppressants.
- •Individuals with major surgeries within the last 1 month or gastrointestinal surgery in the last 3month.
- •Operated patients for carcinoma cervix.
- •Individuals undergoing dietary restriction and or pharmacological treatment for the decrease of body weight 2 months prior to the beginning of the study.
- •Women on Oral contraceptive Pills.
- •Individuals with Intensive Physical Activity (More than 2 hours,3 times per week).
- •Individual taking prebiotics or probiotics during the 4 weeks prior to the beginning of the study.
- •Alcoholic or Drug addicted Individuals.
- •Individuals with regular use of Laxatives ( More than 2 times per week).
结局指标
主要结局
To study the effects of microbiota based personalised diet on quality-of-life parameters of cervical cancer patients undergoing chemo and radiotherapy.
时间窗: Day 1 to day 90
次要结局
- To evaluate any Adverse Event or Discomfort occurring due to BugSpeaks® based personalised nutrition.(Day 1 to day 90)
研究者
Dr Siddhartha Nanda
All India Institute of Medical Sciences, Raipur