| CTRI Number |
CTRI/2023/08/056565 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to understand the effect of diet plan among cancer patients getting discharged with nasogastric tube |
|
Scientific Title of Study
|
Effect of tailored diet plan on nutritional status, compliance, barriers and patient satisfaction among the cancer patients discharged with the nasogastric tube at AIIMS, New Delhi-A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanchari Roy |
| Designation |
M.Sc. Nursing Student(Oncology) |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Hostel number 15, Room No N-310 Medha hostel, AIIMS Residential Complex, Opposite to Masjid Moth, AIIMS, New Delhi
Department- College Of Nursing
21, College Street, Kolkata - 700073
South West
DELHI
110049
India |
| Phone |
09123029312 |
| Fax |
|
| Email |
sanchari1761999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Aditi Prashant Sinha |
| Designation |
Associate Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department: COLLEGE OF NURSING NEW DELHI, Room No: 4
South West
DELHI
110029
India |
| Phone |
9810784806 |
| Fax |
|
| Email |
aaditiprashant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Aditi Prashant Sinha |
| Designation |
Associate Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department: COLLEGE OF NURSING NEW DELHI
Room No: 4
South West
DELHI
110029
India |
| Phone |
9810784806 |
| Fax |
|
| Email |
aaditiprashant@gmail.com |
|
|
Source of Monetary or Material Support
|
| PATHOLOGY AND BIOCHEMISTRY LABORATORIES OF AIIMS NEW DELHI ANSARI NAGAR PIN-110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
COLLEGE OF NURSING AIIMS NEW DELHI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SANCHARI ROY |
AIIMS NEW DELHI |
IRCH department radiotherapy ward 1st floor and 2nd floor, surgery ward 1st floor and 5th floor, OPD ground floor
South West
DELHI |
9123029312
sanchari1761999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ROUTINE DISCHARGE ADVISE |
NO INTERVENTION TO THE CONTROL GROUP |
| Intervention |
TAILORED DIET PLAN |
The intervention group will be counselled to take kitchen-based feed with raw egg.
If the patient is non eggetarian, he or she will be counselled to take the vegetable puree feed. There are three diet plans based on BMI (less than 18 kg per m2,18 kg per m2 to 25 kg per m2 and more than 25 kg per m2). The patients BMI will be calculated and the corresponding diet will be followed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Post operative patients with oral and gastrointestinal cancer discharged with nasogastric tube.
Post operative patients undergoing radiotherapy.
People having ability to read Hindi and English.
|
|
| ExclusionCriteria |
| Details |
Cancer patients coming for readmission with nasogastric tube
Patients who were on total parenteral nutrition.
Patients not willing to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NUTRITIONAL STATUS |
BASELINE 4 WEEKS 6 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COMPLIANCE BARRIERS PATIENT SATISFACTION |
4 WEEKS 4
6 WEEKA
S |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/08/2023 |
| Date of Study Completion (India) |
27/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
NEED OF THE STUDY:
There
are many studies conducted on hospitalized patients with nutritional
interventions but very few studies focus on the post discharged group of
patients(3). The compliance towards the diet plan is more among the
hospitalized patients probably due to it is
managed by professionals, and it’s the part of routine practice compared to the
patients who gets discharged(8). Therefore, to maintain adequate weight,
the compliance to the nutritional treatment is very essential even after the
discharge. As per the reviewed literature, none
of the study has explored the application of tailored diet plan for tube
feeding (NG) patients getting discharged. The barriers and
patient satisfaction to the tailored structured diet plan will further enhance
the understanding for non-compliance. There are very few studies which has
covered the tailored diet plan for patients getting discharged with nasogastric
tube. This study will develop evidence in effectiveness of tailored structured
diet plan during the discharge of patients with nasogastric tube.
|