| CTRI Number |
CTRI/2019/11/022160 [Registered on: 26/11/2019] Trial Registered Prospectively |
| Last Modified On: |
26/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of medicinal plant based nutritional formulation as an adjuvant in gastrointestinal cancer therapy |
|
Scientific Title of Study
|
Efficacy of medicinal plant based nutritional formulation as an adjuvant in gastrointestinal cancer therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lohith MS |
| Designation |
UGC-BSR-SRF |
| Affiliation |
University of Mysore |
| Address |
DOS in Food Science and Nutrition,Manasagangotri, University of Mysore,Mysuru.
598, Shankar mutt street, Chamaraja Mohalla, Mysuru-24
Mysore
KARNATAKA
570006
India |
| Phone |
8951478491 |
| Fax |
|
| Email |
lohith.ms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asna Urooj |
| Designation |
Professor |
| Affiliation |
University of Mysore |
| Address |
DOS in Food Science and Nutrition,Manasagangotri, University of Mysore,Mysuru.
Mysore
KARNATAKA
570006
India |
| Phone |
9448489334 |
| Fax |
0821-2419632 |
| Email |
asnaurooj@foodsci.uni-mysore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Lohith MS |
| Designation |
UGC-BSR-SRF |
| Affiliation |
University of Mysore |
| Address |
DOS in Food Science and Nutrition,Manasagangotri, University of Mysore,Mysuru.
598, Shankar mutt street, Chamaraja Mohalla, Mysuru-24
Mysore
KARNATAKA
570006
India |
| Phone |
8951478491 |
| Fax |
|
| Email |
lohith.ms@gmail.com |
|
|
Source of Monetary or Material Support
|
| UGC-DRS II project co-ordinated by Dr. Asna Urooj, DOS in Food Science and Nutrition, Manasagangotri, University of Mysore and UGC-BSR fellowship awarded to the PI. |
|
|
Primary Sponsor
|
| Name |
UGC DRS II project |
| Address |
University Grants Commission, Bahadur Shah Zafar Marg, New Delhi, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| UGC BSR fellowship |
University Grants Commission, Bahadur Shah Zafar Marg, New Delhi, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Thomas and Ms Rene Thomas |
Preethi Centre for Oncology |
#873,M.G Road,Lakshmipuram, Vani Vilas Double Rd, Sunnadakeri, Rahmania Mohalla, Mysuru, Karnataka 570004
Mysore
KARNATAKA |
9845109933
dr.anilt@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nutrition Intervention Study |
Nutrition intervention of a high energy high protein food formulation enriched with Annona reticulata aqueous leaves extract, developed for gastrointestinal cancer patients with parameters such as body composition, anthropometric, biochemical, nutritional, dietary and QoL will be compared at baseline, during (4th week) and after intervention (8th week).
Note: Acute toxicity studies of Annona reticulata leaves has been conducted in swiss albino mice model and no adverse effects were observed. (Reference: Shivanna, L. M., Sarjan, H. N., & Urooj, A. (2019). Acute Toxicity Study of Annona reticulata Leaves Extract in Swiss Albino Mice. International Journal of Pharmaceutical Investigation, 9(2), 71-75. https://doi.org/10.5530/ijpi.2019.2.14)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Clinician diagnosed subjects with histopathologically confirmed Gastrointestinal cancer of both the genders aged above 18years undergoing chemotherapy and/or radiotherapy. |
|
| ExclusionCriteria |
| Details |
Subjects with terminal illness or other serious co-morbidities, pregnant women and the vulnerable group. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Alleviation of NIS (PG-SGA tool) and improvement in nutritional status (PG-SGA tool) and quality of life (EORTC tool). |
Baseline, 4th week and 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the inflammatory markers (CRP) and improvement in the antioxidant status (Serum) is expected. |
Baseline, 4th week and 8th week |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
https://www.jpionline.org/index.php/ijpi/article/view/373 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
is a randomized, open label, nutrition intervention study to evaluate the
efficacy of a high energy high protein food formulation enriched with Annona reticulata aqueous leaves extract
in the management of gastrointestinal cancers in patients undergoing
chemotherapy and/or radiotherapy. Primary outcome expected is alleviation of
NIS, improvement in nutritional status and quality of life. The food
formulation is composed of Wheat, Rice, Ragi, Bengal gram, Green gram, Whey
protein concentrate, Encapsulated maltodextrin containing the extract, Coconut
oil and Palm oil. Each patient will receive 100g of food
formulation per day during the study period.
Parameters
such as body composition, somatic, biochemical, dietary, antioxidant status and
quality of life will be evaluated at baseline, during intervention (4th
week) and after intervention (8th week) to evaluate the efficacy of
the food formulation in the management of gastrointestinal cancer.
Note: 5 mL of blood will be drawn to analyze the haematological
and biochemical parameters during the study period at three occasions.
|