Cancer Clinical Trial
Official title:
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
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.
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.
Haemoglobin and serum albumin levels were assessed at the start of the study, after 3 months
and at 6 months of intervention for all patients.
Indian Migrant Study Physical Activity questionnaire (IMS-PAQ) was used to assess patients'
physical activity throughout the day.
Anthropometric estimations included body weight, mid upper arm circumference and four site
skin fold thickness (SFT) measurement (i.e. triceps, biceps, subscapular and suprailiac).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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