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NCT Number: NCT02561143

Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients

Investigators are evaluating the nutritional role of IAtta supplementation along with nutritional counselling in delaying the progression of cachexia to refractory cachexia in adult cancer Indian patients. Patients will receive IAtta (100 g) or whole wheat flour (100 g) for daily consumption for 6 months. Dietary and physical activity counseling will be imparted every fortnight to patients.

Nutritional, biochemical, quality of life and anthropometric estimations will be assessed at baseline, after 3 months and at 6 months of intervention for all patients.

Investigators hypothesize that intake of nutrient rich bread mix IAtta (along with dietary and physical activity counselling) for six months will improve the health status and quality of life 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

Not applicable

Primary location

All India Institute of Medical Sciences, New Delhi, India

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About this study

Patients will be randomly distributed into two groups i.e. control and intervention group. 75 patients will be allocated in intervention group and receive nutrient rich flour mix i.e. IAtta (100 g) along with dietary and physical activity counseling and 75 patients will be allocated in the control group who will receive whole wheat flour with dietary and physical activity counseling. Intervention group patients will collect 14 packets of 100 g of IAtta every fortnight during their clinician appointments while the control patients will collect 14 packets of 100 g of whole wheat flour at every clinician visit for 6 months.

Dietary counseling for 30 minutes will be imparted to all patients on each visit by the nutritionist. Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions.

Nutritional, biochemical, quality of life and anthropometric estimations would be assessed at baseline, after 3 months and at 6 months of intervention for all patients.

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 will be given 100 grams of Improved Atta (to make unleavened bread) everyday for consumption for six months.

Wheat flour

Dietary Supplement

Whole wheat flour 100 grams (to make unleavened bread) will be given everyday for consumption for six months to the patients.

Physical activity counseling

Behavioral

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

nutritional counseling

Other

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

Primary outcomes

  1. Change in body weight at 6 months

    Time frame: Baseline, 3 months & 6 months

    Body weight in kilograms will be assessed using a Tanita segmental composition scale at baseline, mid-intervention (3 months) and at the end of intervention (6 months).

Secondary outcomes

  1. Change in mid upper arm circumference (MUAC) at 6 months

    Time frame: Baseline, 3 months & 6 months

    MUAC in centimeters will be measured using a non-stretchable measuring tape at baseline, mid-intervention (3 months) and at the end of intervention (6 months).

  2. Change in body fat percentage (BF%) at 6 months

    Time frame: Baseline, 3 months & 6 months

    Four site skin fold thickness (SFT) measurement (i.e. triceps, biceps, subscapular and suprailiac) by the help of scientific Harpenden Skinfold Caliper will be noted to the nearest 0.2mm reading, to calculate percentage body density. Body fat percentage will be calculated using body density value in Siri equation.

    SFT will be measured at baseline, mid-intervention (3 months) and end of intervention (6 months) to determine the BF%.

  3. Indian Migrant study food frequency questionnaire (IMS-FFQ)

    Time frame: Baseline, 3 months & 6 months

    IMS-FFQ will be used to assess patient's daily energy (kcal), protein (g) and fat (g) intake at baseline, mid-intervention and end of intervention (6 months).

    Food frequency questionnaire is an accurate method to record the frequency of consumption of individual foods and can help provide information on patients' eating patterns. IMS-FFQ (Indian Migrant Study- Food Frequency Questionnaire) consists of 184 commonly consumed food items and is validated among the rural and urban Indian population.

  4. Two day 24 hour dietary recall

    Time frame: Baseline, 3 months & 6 months

    Two day 24 hour dietary recall will be used to assess patient's daily energy (kcal), protein (g) and fat (g) intake at baseline, mid-intervention and end of intervention (6 months).

    24 hour dietary recall is an accurate method to understand patients' eating patterns.

  5. Patient generated subjective global assessment (PGSGA)

    Time frame: Baseline, 3 months & 6 months

    PGSGA will be used to assess patient nutritional status (category: well nourished, malnourished & severely malnourished) at baseline, mid-intervention and end of intervention (6 months).

    PG-SGA is most effective and sensitive tool for assessing and evaluating cancer patients' nutritional status and validated on Indian cancer patients.

  6. Indian Migrant Study Physical Activity Questionnaire (IMS-PAQ)

    Time frame: Baseline, 3 months & 6 months

    IMS-PAQ will assess patients' physical activity throughout the day. Investigators will asses 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. Patients' will report every activity performed with the average amount of time spent for each activity in the questionnaire. Thereafter, investigators will calculate the average calories spent by every patient in the whole day.

  7. Change in quality of life by EORTC-QLQ- C30 (Quality of life Questionnaire) at 6 months

    Time frame: Baseline, 3 months & 6 months

    EORTC-QLQ- C30 (European Organization for Research &Treatment of cancer) questionnaire will be used to analyse patients' quality of life at baseline, mid- intervention and at the end of intervention period. A score will be calculated for all the15 domains covered in the questionnaire of 30 questions.These domains will be analysed and compared for the outcome in the two groups.

  8. Change in haemoglobin levels at 6 months

    Time frame: Baseline, 3 months & 6 months

    Haemoglobin levels (g/dl) will be monitored at baseline, at three months and at the end of intervention (6 months).

  9. Change in serum albumin levels

    Time frame: Baseline, 3 months & 6 months

    Serum albumin (g%) levels will be monitored at baseline, at three months and at the end of intervention (6 months).

  10. Change in C-reactive protein levels at 6 months

    Time frame: Baseline & 6 months

    C-reactive protein (mg/L) levels will be monitored at baseline 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 Evaluate the Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Delaying Progression of Cachexia to Refractory Cachexia in Adult Cancer Patients in Indian Population

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 25, 2015
Registry last updated
Jun 22, 2017

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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