To Evaluate the Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Delaying Progression of Cachexia to Refractory Cachexia in Adult Cancer Patients in Indian Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Change in body weight at 6 months
研究概览
简要总结
Investigators are evaluating the nutritional role of IAtta supplementation along with nutritional counselling in delaying the progression of cachexia to refractory cachexia in adult cancer Indian patients. Patients will receive IAtta (100 g) or whole wheat flour (100 g) for daily consumption for 6 months. Dietary and physical activity counseling will be imparted every fortnight to patients.
Nutritional, biochemical, quality of life and anthropometric estimations will be assessed at baseline, after 3 months and at 6 months of intervention for all patients.
Investigators hypothesize that intake of nutrient rich bread mix IAtta (along with dietary and physical activity counselling) for six months will improve the health status and quality of life in free-living patients suffering from cancer cachexia.
详细描述
Patients will be randomly distributed into two groups i.e. control and intervention group. 75 patients will be allocated in intervention group and receive nutrient rich flour mix i.e. IAtta (100 g) along with dietary and physical activity counseling and 75 patients will be allocated in the control group who will receive whole wheat flour with dietary and physical activity counseling. Intervention group patients will collect 14 packets of 100 g of IAtta every fortnight during their clinician appointments while the control patients will collect 14 packets of 100 g of whole wheat flour at every clinician visit for 6 months.
Dietary counseling for 30 minutes will be imparted to all patients on each visit by the nutritionist. Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions.
Nutritional, biochemical, quality of life and anthropometric estimations would be assessed at baseline, after 3 months and at 6 months of intervention for all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age 18 years and above.
- •Diagnosed with cancer.
- •Weight loss >5% from pre-treatment weight or BMI<20kg/m
- •Hemoglobin level <12 g/dl.
- •Energy intake < 1500 kcal/d (to be assessed on consultation)
排除标准
- •Incapable to provide written consent.
- •Patient diagnosed with refractory cachexia.
- •Life expectancy < 3 months.
- •Unresponsive to anti-cancer therapy.
- •Patient is a pregnant woman or a nursing mother.
- •Suffering from secondary illnesses.
- •Gastrointestinal tract defects which affect nutrient absorption.
结局指标
主要结局
Change in body weight at 6 months
时间窗: Baseline, 3 months & 6 months
Body weight in kilograms will be assessed using a Tanita segmental composition scale at baseline, mid-intervention (3 months) and at the end of intervention (6 months).
次要结局
- Change in body fat percentage (BF%) at 6 months(Baseline, 3 months & 6 months)
- Change in mid upper arm circumference (MUAC) at 6 months(Baseline, 3 months & 6 months)
- Change in haemoglobin levels at 6 months(Baseline, 3 months & 6 months)
- Indian Migrant Study Physical Activity Questionnaire (IMS-PAQ)(Baseline, 3 months & 6 months)
- Change in serum albumin levels(Baseline, 3 months & 6 months)
- Indian Migrant study food frequency questionnaire (IMS-FFQ)(Baseline, 3 months & 6 months)
- Two day 24 hour dietary recall(Baseline, 3 months & 6 months)
- Patient generated subjective global assessment (PGSGA)(Baseline, 3 months & 6 months)
- Change in quality of life by EORTC-QLQ- C30 (Quality of life Questionnaire) at 6 months(Baseline, 3 months & 6 months)
- Change in C-reactive protein levels at 6 months(Baseline & 6 months)
研究者
Neha Kapoor
Research Scholar
University of Westminster