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AzTrials

CachexiaPhase 2NCT02350855

Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients

A Phase 2 study testing Improved Atta, Nutritional counseling and Physical activity counseling in people with Cachexia and Cancer, run by University of Westminster at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cachexia, Cancer
What is being tested?
Improved Atta, Nutritional counseling and Physical activity counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
2 sitesin 2 countries
Study dates
Dec 2013to Aug 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

India1 site

  • All India Institute of Medical Sciences

    New Delhi, 110029

Other trials in India

United Kingdom1 site

  • University of Westminster

    London, W1W 6UW

Other trials in United Kingdom

About this study

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

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.

Read the 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).

Conditions
Cachexia, Cancer
Being tested
Improved Atta, Nutritional counseling, Physical activity counseling
Keywords
Nutrition intervention, Palliative care, Public Health, Quality of life, Tailored food formula, Body weight
Medical subject headings
Cachexia, Neoplasms, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Improved AttaDietary 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 counselingOther

    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 counselingBehavioural

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

Study groups in NCT02350855
Study groupRoleWhat they receive
Intervention groupExperimentalPatients in the intervention group were given dietary supplement (Improved Atta: 100 g) daily along with nutritional counseling and physical activity counseling for six months.
Receives: Dietary Supplement: Improved Atta; Other: Nutritional counseling; Behavioral: Physical activity counseling
Control groupOtherPatients in the control group were given nutritional and physical activity counseling for six months every fortnight.
Receives: Other: Nutritional counseling; Behavioral: Physical activity counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 6 months

Secondary outcomes (7)

  1. 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).

    Measured: 6 months

  2. 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%.

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 6 months

  6. Haemoglobin (Haemoglobin levels)

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

    Measured: 6 months

  7. Serum albumin (Serum albumin levels)

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2015 (estimated)
  2. Study startDec 2013
  3. Primary completionJul 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02350855
Sponsor's protocol ID
12_13_11
Status last verified
Jan 2015
First submitted
26 Jan 2015
Last updated
30 Jan 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27252077

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Improved Atta, Nutritional counseling and Physical activity counseling in people with Cachexia and Cancer, run by University of Westminster at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02350855, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2015.

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