Clinical Trial: Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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'
Sponsor: University of Westminster

Current Primary Outcome: Body weight [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Mid upper arm circumference (MUAC) [ Time Frame: 6 months ]
  MUAC was measured using a non-stretchable measuring tape at baseline, mid-intervention (3 months) and at the end of intervention (6 months).
• Body fat percentage (BF%) [ Time Frame: 6 months ]
  Four site skin fold thickness (SFT) measurement (i.e. triceps, biceps, subscapular and suprailiac) by the help of scientific Harpenden Skinfold Caliper was noted to the nearest 0.2mm reading, to calculate percentage body density. Body fat percentage was calculated using body density value in Siri equation. SFT was measured at baseline, mid-intervention (3 months) and end of intervention (6 months) to determine the BF%.
• Nutritional status assessment (Indian Migrant study food frequency questionnaire (IMS-FFQ), two day 24 hour dietary recall and patient generated subjective global assessment) [ Time Frame: 6 months ]

  Indian Migrant study food frequency questionnaire (IMS-FFQ), two day 24 hour dietary recall and patient generated subjective global assessment were used to assess patient nutritional status at baseline, mid-intervention and end of intervention (6 months).

  Food frequency questionnaire and 24 hour dietary recall is an accurate method to record the frequency of consumption of individual foods and can help provide information on patients' eating patterns.IMS-FFQ consists of 184 commonly consumed food items and was validated among the rural and urban Indian population. PG-SGA is most effective and sensitive tool for assessing and evaluating cancer patients' nutritional status and validated on Indian cancer patients.

• Physical activity assessment (Indian Migrant Study Physical Activity questionnaire (IMS-PAQ) [ Time Frame: 6 months ]

  Indian Migrant Study Physical Activity questionnaire (IMS-PAQ) was used to assess patients' physical activity throughout the day. We assessed physical activity at three time points during the study: baseline, at 3 months of intervention and at 6 months end of intervention.

  IMS-PAQ is a validated questionnaire on both Indian rural and urban population.

• Quality of life (QoL) assessment (EORTC-QLQ- C30 questionnaire) [ Time Frame: 6 months ]
  EORTC-QLQ- C30 questionnaire was used to analyse patients' QoL at baseline, mid- intervention and at the end of intervention period.
• Haemoglobin (Haemoglobin levels) [ Time Frame: 6 months ]
  Haemoglobin levels were monitored at baseline, at three months and at the end of intervention (6 months).
• Serum albumin (Serum albumin levels) [ Time Frame: 6 months ]
  Serum albumin levels were monitored at baseline, at three months and at the end of intervention (6 months).

Original Secondary Outcome: Same as current

Information By: University of Westminster

Dates:
Date Received: January 26, 2015
Date Started: December 2013
Date Completion:
Last Updated: January 29, 2015
Last Verified: January 2015