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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Westminster
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Body weight
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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
Arms & Interventions
Intervention group
Patients in the intervention group were given dietary supplement (Improved Atta: 100 g) daily along with nutritional counseling and physical activity counseling for six months.
Intervention: Improved Atta (Dietary Supplement)
Intervention group
Patients in the intervention group were given dietary supplement (Improved Atta: 100 g) daily along with nutritional counseling and physical activity counseling for six months.
Intervention: Nutritional counseling (Other)
Intervention group
Patients in the intervention group were given dietary supplement (Improved Atta: 100 g) daily along with nutritional counseling and physical activity counseling for six months.
Intervention: Physical activity counseling (Behavioral)
Control group
Patients in the control group were given nutritional and physical activity counseling for six months every fortnight.
Intervention: Nutritional counseling (Other)
Control group
Patients in the control group were given nutritional and physical activity counseling for six months every fortnight.
Intervention: Physical activity counseling (Behavioral)
Outcomes
Primary Outcomes
Body weight
Time Frame: 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).
Secondary Outcomes
- Mid upper arm circumference (MUAC)(6 months)
- Body fat percentage (BF%)(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)
Investigators
Neha Kapoor
Research Scholar
University of Westminster