Clinical trial NCT02350855: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cachexia
Cancer
Keywords: Nutrition intervention
Palliative care
Public Health
Quality of life
Tailored food formula
Body weight
Lead sponsor: University of Westminster
Sponsor class: OTHER
Collaborators: name: All India Institute of Medical Sciences
First posted: 2015-01-30
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Body weight
timeFrame: 6 months
Secondary outcomes:
measure: Mid upper arm circumference (MUAC)
timeFrame: 6 months
measure: Body fat percentage (BF%)
timeFrame: 6 months
measure: Nutritional status assessment (Indian Migrant study food frequency questionnaire (IMS-FFQ), two day 24 hour dietary recall and patient generated subjective global assessment)
timeFrame: 6 months
measure: Physical activity assessment (Indian Migrant Study Physical Activity questionnaire (IMS-PAQ)
timeFrame: 6 months
measure: Quality of life (QoL) assessment (EORTC-QLQ- C30 questionnaire)
timeFrame: 6 months
measure: Haemoglobin (Haemoglobin levels)
timeFrame: 6 months
measure: Serum albumin (Serum albumin levels)
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: London
country: United Kingdom
facility: University of Westminster
Study officials:
affiliation: University of Westminster
name: Ihab Tewfik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.