CachexiaNCT02561143
Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients
A study testing Improved Atta, Wheat flour and Physical activity counseling in people with Cachexia and Cancer, run by University of Westminster at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Improved Atta, Wheat flour and Physical activity counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2015to May 2016
- Phase
- Interventional
- 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
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Improved Atta, Wheat flour, Physical activity counseling, Nutritional counseling
- Keywords
- cachexia, nutrition supplementation, IAtta, palliative care, quality of life
- Medical subject headings
- Cachexia, Neoplasms
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 will be given 100 grams of Improved Atta (to make unleavened bread) everyday for consumption for six months.
Wheat flourDietary supplement
Whole wheat flour 100 grams (to make unleavened bread) will be given everyday for consumption for six months to the patients.
Physical activity counselingBehavioural
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 counselingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in the intervention group will be given dietary supplement (Improved Atta: 100 g) daily along with nutritional counseling and physical activity counseling for six months. Receives: Dietary Supplement: Improved Atta; Behavioral: Physical activity counseling; Other: Nutritional counseling |
| Control group | Placebo comparator | Patients in the control group will be given whole wheat flour (100 g) daily along with nutritional counseling and physical activity counseling for six months. Receives: Dietary Supplement: Wheat flour; Behavioral: Physical activity counseling; Other: Nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight at 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).
Measured: Baseline, 3 months & 6 months
Secondary outcomes (10)
Change in mid upper arm circumference (MUAC) at 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).
Measured: Baseline, 3 months & 6 months
Change in body fat percentage (BF%) at 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%.
Measured: Baseline, 3 months & 6 months
Indian Migrant study food frequency questionnaire (IMS-FFQ)
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.
Measured: Baseline, 3 months & 6 months
Two day 24 hour dietary recall
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.
Measured: Baseline, 3 months & 6 months
Patient generated subjective global assessment (PGSGA)
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.
Measured: Baseline, 3 months & 6 months
Indian Migrant Study Physical Activity Questionnaire (IMS-PAQ)
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.
Measured: Baseline, 3 months & 6 months
Change in quality of life by EORTC-QLQ- C30 (Quality of life Questionnaire) at 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.
Measured: Baseline, 3 months & 6 months
Change in haemoglobin levels at 6 months
Haemoglobin levels (g/dl) will be monitored at baseline, at three months and at the end of intervention (6 months).
Measured: Baseline, 3 months & 6 months
Change in serum albumin levels
Serum albumin (g%) levels will be monitored at baseline, at three months and at the end of intervention (6 months).
Measured: Baseline, 3 months & 6 months
Change in C-reactive protein levels at 6 months
C-reactive protein (mg/L) levels will be monitored at baseline and at the end of intervention (6 months).
Measured: Baseline & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Westminster
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Sciences
- Responsible party
- Principal investigator, Neha Kapoor, University of Westminster
- Investigators
- Neha Kapoor, PhD, Principal investigator, University of WestminsterIhab Tewfik, PhD, Study director, University of Westminster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561143
- Sponsor's protocol ID
- IEC/NP-339/08.10.2014
- Status last verified
- Jun 2017
- First submitted
- 21 Sep 2015
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kapoor N, Naufahu J, Tewfik S, Bhatnagar S, Garg R, Tewfik I. A public health nutrition intervention to delay the progression of cachexia to refractory cachexia in indian female cancer patients. Int. J. Food, Nutrition and Public Health. 2014;7:1-11.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02561143
- Acronym / sponsor ID
- IEC/NP-339/08.10.2014
- Keywords
- cachexia, nutrition supplementation, IAtta, palliative care, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of WestminsterUniversity, hospital or other
- Collaborators
- All India Institute of Medical Sciences
- Study start
- Apr 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Improved Atta, Behavioral: Physical activity counseling, Other: Nutritional counselingPatients in the intervention group will be given dietary supplement (Improved Atta: 100 g) daily along with nutritional counseling and physical activity counseling for six months. |
| Control group | Placebo comparator | Dietary Supplement: Wheat flour, Behavioral: Physical activity counseling, Other: Nutritional counselingPatients in the control group will be given whole wheat flour (100 g) daily along with nutritional counseling and physical activity counseling for six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improved AttaImproved 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. | Dietary supplement | Intervention group |
| Wheat flourWhole wheat flour 100 grams (to make unleavened bread) will be given everyday for consumption for six months to the patients. | Dietary supplement | Control group |
| Physical activity counselingDepending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions. | Behavioural | Control group, Intervention group |
| Nutritional counselingDietary 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. | Other | Control group, Intervention group |
Primary outcome
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).
10 secondary outcomes
Change in mid upper arm circumference (MUAC) at 6 months
Time frame: Baseline, 3 months & 6 months
Change in body fat percentage (BF%) at 6 months
Time frame: Baseline, 3 months & 6 months
Indian Migrant study food frequency questionnaire (IMS-FFQ)
Time frame: Baseline, 3 months & 6 months
Two day 24 hour dietary recall
Time frame: Baseline, 3 months & 6 months
Patient generated subjective global assessment (PGSGA)
Time frame: Baseline, 3 months & 6 months
Indian Migrant Study Physical Activity Questionnaire (IMS-PAQ)
Time frame: Baseline, 3 months & 6 months
Change in quality of life by EORTC-QLQ- C30 (Quality of life Questionnaire) at 6 months
Time frame: Baseline, 3 months & 6 months
Change in haemoglobin levels at 6 months
Time frame: Baseline, 3 months & 6 months
Change in serum albumin levels
Time frame: Baseline, 3 months & 6 months
Change in C-reactive protein levels at 6 months
Time frame: Baseline & 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- BackgroundKapoor N, Naufahu J, Tewfik S, Bhatnagar S, Garg R, Tewfik I. A public health nutrition intervention to delay the progression of cachexia to refractory cachexia in indian female cancer patients. Int. J. Food, Nutrition and Public Health. 2014;7:1-11.
Related trials for Cachexia
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
Not yet recruiting
Neuromuscular Electrical Stimulation to Improve the Muscle Health of Individuals With Acute Kidney Injury
Acute Kidney Injury, Acute Kidney Injury KDIGO 2
RecruitingPhase 2
Safety and Efficacy of KER-065 in Participants With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Kapoor, PhD principal investigator
University of Westminster
Ihab Tewfik, PhD study director
University of Westminster
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improved Atta, Wheat flour 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 22 Jun 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in body weight at 6 months (time frame: Baseline, 3 months & 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 NCT02561143, 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 22 Jun 2017.