|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02561143 |
|
Date of registration:
|
21/09/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients
|
|
Scientific 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 |
|
Date of first enrolment:
|
April 2015 |
|
Target sample size:
|
150 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02561143 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Investigator).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
India
|
United Kingdom
| | | | | | |
|
Contacts
|
|
Name:
|
Neha Kapoor, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Westminster |
|
|
Name:
|
Ihab Tewfik, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Westminster |
| |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Cachexia
|
|
Cancer
|
|
Intervention(s)
|
|
Dietary Supplement: Wheat flour
|
|
Other: Nutritional counseling
|
|
Behavioral: Physical activity counseling
|
|
Dietary Supplement: Improved Atta
|
|
Primary Outcome(s)
|
|
Change in body weight at 6 months
[Time Frame: Baseline, 3 months & 6 months]
|
|
Secondary Outcome(s)
|
|
Change in haemoglobin levels at 6 months
[Time Frame: Baseline, 3 months & 6 months]
|
|
Patient generated subjective global assessment (PGSGA)
[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]
|
|
Indian Migrant Study Physical Activity Questionnaire (IMS-PAQ)
[Time Frame: Baseline, 3 months & 6 months]
|
|
Indian Migrant study food frequency questionnaire (IMS-FFQ)
[Time Frame: Baseline, 3 months & 6 months]
|
|
Change in body fat percentage (BF%) at 6 months
[Time Frame: Baseline, 3 months & 6 months]
|
|
Change in C-reactive protein levels at 6 months
[Time Frame: Baseline & 6 months]
|
|
Change in serum albumin levels
[Time Frame: Baseline, 3 months & 6 months]
|
|
Two day 24 hour dietary recall
[Time Frame: Baseline, 3 months & 6 months]
|
|
Change in mid upper arm circumference (MUAC) at 6 months
[Time Frame: Baseline, 3 months & 6 months]
|
|
Secondary ID(s)
|
|
IEC/NP-339/08.10.2014
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|