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Completed

NCT Number: NCT02350855

Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients

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.

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Key information

Conditions

Cachexia Body Weight Body Weight Changes Cancer Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

All India Institute of Medical Sciences, New Delhi, India

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Body weight

    Time frame: 6 months

    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 outcomes

  1. 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).

  2. 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%.

  3. 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.

  4. 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.

  5. 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.

  6. Haemoglobin (Haemoglobin levels)

    Time frame: 6 months

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

  7. 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).

Sponsors and collaborators

Lead sponsor

University of Westminster

Other

Collaborators

  • All India Institute of Medical Sciences

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2015
Registry last updated
Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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