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Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients

Primary Purpose

Cachexia, Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Improved Atta
Nutritional counseling
Physical activity counseling
Sponsored by
University of Westminster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cachexia focused on measuring Nutrition intervention, Palliative care, Public Health, Quality of life, Tailored food formula, Body weight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • All India Institute of Medical Sciences
  • University of Westminster

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group

Control group

Arm Description

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.

Patients in the control group were given nutritional and physical activity counseling for six months every fortnight.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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%.
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.
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.
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.
Haemoglobin (Haemoglobin levels)
Haemoglobin levels were monitored at baseline, at three months and at the end of intervention (6 months).
Serum albumin (Serum albumin levels)
Serum albumin levels were monitored at baseline, at three months and at the end of intervention (6 months).

Full Information

First Posted
January 26, 2015
Last Updated
January 29, 2015
Sponsor
University of Westminster
Collaborators
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT02350855
Brief Title
Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Westminster
Collaborators
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia, Cancer
Keywords
Nutrition intervention, Palliative care, Public Health, Quality of life, Tailored food formula, Body weight

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
Patients in the control group were given nutritional and physical activity counseling for six months every fortnight.
Intervention Type
Dietary Supplement
Intervention Name(s)
Improved Atta
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nutritional counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity counseling
Intervention Description
Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.
Primary Outcome Measure Information:
Title
Body weight
Description
Body weight was assessed using a Tanita segmental composition scale at baseline, mid-intervention (3 months) and at the end of intervention (6 months).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mid upper arm circumference (MUAC)
Description
MUAC was measured using a non-stretchable measuring tape at baseline, mid-intervention (3 months) and at the end of intervention (6 months).
Time Frame
6 months
Title
Body fat percentage (BF%)
Description
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%.
Time Frame
6 months
Title
Nutritional status assessment (Indian Migrant study food frequency questionnaire (IMS-FFQ), two day 24 hour dietary recall and patient generated subjective global assessment)
Description
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.
Time Frame
6 months
Title
Physical activity assessment (Indian Migrant Study Physical Activity questionnaire (IMS-PAQ)
Description
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.
Time Frame
6 months
Title
Quality of life (QoL) assessment (EORTC-QLQ- C30 questionnaire)
Description
EORTC-QLQ- C30 questionnaire was used to analyse patients' QoL at baseline, mid- intervention and at the end of intervention period.
Time Frame
6 months
Title
Haemoglobin (Haemoglobin levels)
Description
Haemoglobin levels were monitored at baseline, at three months and at the end of intervention (6 months).
Time Frame
6 months
Title
Serum albumin (Serum albumin levels)
Description
Serum albumin levels were monitored at baseline, at three months and at the end of intervention (6 months).
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ihab Tewfik, PhD
Organizational Affiliation
University of Westminster
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
University of Westminster
City
London
ZIP/Postal Code
W1W 6UW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27252077
Citation
Kapoor N, Naufahu J, Tewfik S, Bhatnagar S, Garg R, Tewfik I. A Prospective Randomized Controlled Trial to Study the Impact of a Nutrition-Sensitive Intervention on Adult Women With Cancer Cachexia Undergoing Palliative Care in India. Integr Cancer Ther. 2017 Mar;16(1):74-84. doi: 10.1177/1534735416651968. Epub 2016 Jun 1.
Results Reference
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Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients

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