| CTRI Number |
CTRI/2021/03/031632 [Registered on: 01/03/2021] Trial Registered Prospectively |
| Last Modified On: |
26/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nutritional therapy in carcinoma esophagus patients |
|
Scientific Title of Study
|
Impact of intensely guided enteral nutrition on the malnourished esophageal carcinoma patients: A randomized control study. |
| Trial Acronym |
ESONUT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Sharma |
| Designation |
Associate Professor Surgery |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences, Amritsar |
| Address |
Surgical unit V, Department of Surgery, Sri Guru Ram Das Institute of Medical Sciences and Research, Vallah, Amritsar
Amritsar
PUNJAB
143006
India |
| Phone |
09814651788 |
| Fax |
|
| Email |
drmohit.gis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohit Sharma |
| Designation |
Associate Professor Surgery |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences, Amritsar |
| Address |
Surgery unit V, Department of Surgery, Sri Guru Ram Das Institute of Medical Sciences and Research,Vallah, Amritsar
Amritsar
PUNJAB
143006
India |
| Phone |
09814651788 |
| Fax |
|
| Email |
drmohit.gis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohit Sharma |
| Designation |
Associate Professor Surgery |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences, Amritsar |
| Address |
Surgery unit V, Department of Surgery, Sri Guru Ram Das Institute of Medical Sciences and Research,Vallah, Amritsar
Amritsar
PUNJAB
143006
India |
| Phone |
09814651788 |
| Fax |
|
| Email |
drmohit.gis@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGRDIMS, Vallah, Amritsar, Punjab |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences And Research |
| Address |
SGRDIMS, Vallah, Amritsar, 143006, Punjab |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mohit Sharma |
Sri Guru Ram Das Institute of Medical Sciences And Research |
Surgery unit V, Department of surgery, Sri Guru Ram Das Institute of Medical Sciences And Research Vallah, Amritsar 143006
Amritsar
PUNJAB |
09814651788
drmohit.gis@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee SGRDIMSAR Amritsar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K228||Other specified diseases of esophagus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intensely guided nutritional therapy |
Frequency- Daily
Duration- 8 weeks |
| Comparator Agent |
One time advise on nutrition |
Frequency- not applicable
Duration- 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Histologically proven carcinoma esophagus |
|
| ExclusionCriteria |
| Details |
postesophagectomy patients, patients with previous chemotherapy or radiotherapy, patients requiring parenteral nutrition, refusal of consent |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| impact of intensely guided enteral nutrition on the malnourished status |
Patient generated- subjective global assessment1 First assessment - 4 weeks, Second assessment 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| is to the effect of nutritional therapy on chemotherapy tolerance and radiotherapy tolerance. |
CTACE 1 at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/03/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to know the effect of nutritional support on nutritional status and final oncological outcome of malnourished carcinoma esophagus patients visiting tertiary care hospitals. Primary aim is to study the impact of intensely guided nutritional therapy on malnourished status.. Secondary aim is to study the effect of nutritional therapy on chemotherapy and radiotherapy tolerance.. |