To Study the Impact of Nutritional Intervention in Delaying the Progression of Cachexia to Refractory Cachexia in Female Cancer Patients: A Study Based in India
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Body weight
研究概览
简要总结
The main aim of the study is to assess the effectiveness of tailored nutritional intervention in delaying the progression of cachexia to refractory cachexia in adult female cancer patients.
The tested hypothesis stated that intake of nutrient rich bread mix (along with dietary and physical activity counselling) for six months, improved the anthropometric and biochemical indices in free-living patients suffering from cancer cachexia.
详细描述
Patients were randomly distributed into two groups i.e. control and intervention group. 30 patients were allocated in intervention group and received nutrient rich bread mix i.e. IAtta (100 g) along with dietary and physical activity counseling and 33 patients were allocated in the control group who received only dietary and physical activity counseling. Patients in the intervention group collected 14 packets of 100 g of IAtta every fortnight during their clinician appointments while the control patients were advised regarding their dietary habits at every clinician visit for 6 months.
Dietary counseling for 30 minutes was imparted to all patients on each visit by the researcher. Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.
Nutritional, biochemical, quality of life and anthropometric estimations were assessed at baseline, after 3 months and at 6 months of intervention for all patients.
Patients' daily energy, carbohydrate, protein and fat intake were calculated using food frequency (Indian Migrant study food frequency questionnaire- IMS-FFQ) questionnaire and two day 24 hour recall data. PG-SGA questionnaire was used to monitor patient nutritional status throughout the study.
EORTC-QLQ- C30 questionnaire was used to analyse patients' quality of life and asked personally by the researcher.
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
- None
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
Body weight
时间窗: 6 months
Body weight was 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
- Body fat percentage (BF%)(6 months)
- Mid upper arm circumference (MUAC)(6 months)
- Physical activity assessment (Indian Migrant Study Physical Activity questionnaire (IMS-PAQ)(6 months)
- Quality of life (QoL) assessment (EORTC-QLQ- C30 questionnaire)(6 months)
- Haemoglobin (Haemoglobin levels)(6 months)
- Serum albumin (Serum albumin levels)(6 months)
- Nutritional status assessment (Indian Migrant study food frequency questionnaire (IMS-FFQ), two day 24 hour dietary recall and patient generated subjective global assessment)(6 months)
研究者
Neha Kapoor
Research Scholar
University of Westminster