Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients

NCT02350855 | Completed Phase 2 DMC

• 1 other identifier: 12_13_11
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cachexia; Cancer

Keywords

Nutrition intervention; Palliative care; Public Health; Quality of life; Tailored food formula; Body weight

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Mid upper arm circumference (MUAC)

  6 months

• Body fat percentage (BF%)

  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

• Physical activity assessment (Indian Migrant Study Physical Activity questionnaire (IMS-PAQ)

  6 months

• Quality of life (QoL) assessment (EORTC-QLQ- C30 questionnaire)

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Dietary Supplement: Improved Atta; Other: Nutritional counseling; Behavioral: Physical activity counseling

Control group

OTHER

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

Other: Nutritional counseling; Behavioral: Physical activity counseling

Interventions

Improved Atta DIETARY_SUPPLEMENT

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 group

Nutritional counseling OTHER

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.

Control group; Intervention group

Physical activity counseling BEHAVIORAL

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

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Westminster: lead
• All India Institute of Medical Sciences: collaborator

Study Sites (2)

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

University of Westminster

London, W1W 6UW, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27252077 DERIVED

MeSH Terms

Conditions

Cachexia; Neoplasms; Body Weight

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ihab Tewfik, PhD

  University of Westminster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scholar

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: January 30, 2015
• Study Start: December 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 30, 2015

Record last verified: 2015-01

Locations

IN (1); GB (1)