Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350855
• Other study ID #: 12_13_11
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2015
• Last updated: January 29, 2015
• Start date: December 2013
• Est. completion date: August 2014

Study information

• Verified date: January 2015
• Source: University of Westminster
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female, age 18 years and above.

• Diagnosed with cancer.

• Weight loss >5% from pre-treatment weight or BMI<20kg/m2.

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cachexia
• Cancer

Intervention

Dietary Supplement:
• Improved Atta
Improved Atta is a multi macro- micronutrient bread mix. Patients were given 100 grams of Improved Atta (in the from of unleavened bread) everyday for consumption for six months.

Other:
• Nutritional counseling
Dietary counseling for 30 minutes was imparted to all patients on every hospital visits by the researcher. Consumption of cereals, roots and tubers, vegetables, legumes, nuts, energy dense fruits, milk products (and eggs for non-vegetarians) was encouraged in their daily diets.

Behavioral:
• Physical activity counseling
Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi
United Kingdom	University of Westminster	London

Sponsors (2)

Lead Sponsor	Collaborator
University of Westminster	All India Institute of Medical Sciences, New Delhi

Countries where clinical trial is conducted

India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Body weight was assessed using a Tanita segmental composition scale at baseline, mid-intervention (3 months) and at the end of intervention (6 months).	6 months	No
Secondary	Mid upper arm circumference (MUAC)	MUAC was measured using a non-stretchable measuring tape at baseline, mid-intervention (3 months) and at the end of intervention (6 months).	6 months	No
Secondary	Body fat percentage (BF%)	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%.	6 months	No
Secondary	Nutritional status assessment (Indian Migrant study food frequency questionnaire (IMS-FFQ), two day 24 hour dietary recall and patient generated subjective global assessment)	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.	6 months	No
Secondary	Physical activity assessment (Indian Migrant Study Physical Activity questionnaire (IMS-PAQ)	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.	6 months	No
Secondary	Quality of life (QoL) assessment (EORTC-QLQ- C30 questionnaire)	EORTC-QLQ- C30 questionnaire was used to analyse patients' QoL at baseline, mid- intervention and at the end of intervention period.	6 months	No
Secondary	Haemoglobin (Haemoglobin levels)	Haemoglobin levels were monitored at baseline, at three months and at the end of intervention (6 months).	6 months	Yes
Secondary	Serum albumin (Serum albumin levels)	Serum albumin levels were monitored at baseline, at three months and at the end of intervention (6 months).	6 months	Yes