| CTRI Number |
CTRI/2024/06/069629 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study effects of two feeding tubes, nasogastric tube and feeding jejunostomy, on patients undergoing radiotherapy for oral cancer |
|
Scientific Title of Study
|
Randomised control trial comparing nasogastric tube feeding and feeding jejunostomy in head and neck cancer patients undergoing radiotherapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mekha Ann Andrews |
| Designation |
Senior Resident |
| Affiliation |
Yenepoya University |
| Address |
MCh Surgical Oncology Resident
Department of Surgical Oncology
Yenepoya Medical College
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9687615775 |
| Fax |
|
| Email |
drandrewsmekha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M. Vijayakumar |
| Designation |
Professor |
| Affiliation |
Yenepoya University |
| Address |
Department of Surgical Oncology
Yenepoya Medical College
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9687615775 |
| Fax |
|
| Email |
drandrewsmekha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mekha Ann Andrews |
| Designation |
Senior Resident |
| Affiliation |
Yenepoya University |
| Address |
MCh Surgical Oncology Resident
Department of Surgical Oncology
Yenepoya Medical College
Mangalore
KARNATAKA
575018
India |
| Phone |
9687615775 |
| Fax |
|
| Email |
drandrewsmekha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital |
|
|
Primary Sponsor
|
| Name |
Yenepoya University |
| Address |
Yenepoya Medical College
Mangalore-575018 |
| 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 |
| Dr Mekha Ann Andrews |
Yenepoya Medical College Hospital |
Department of Surgical & Radiation Oncology
YENEPOYA (DEEMED TO BE UNIVERSITY),
University Road, Deralakatte ,
Mangaluru – 575018, Karnataka, India
Dakshina Kannada
KARNATAKA |
9687615775
drandrewsmekha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| YENEPOYA ETHICS COMMITTEE-1 |
Approved |
| YENEPOYA ETHICS COMMITTEE-1 |
Approved |
| YENEPOYA ETHICS COMMITTEE-1 |
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 |
Feeding through jejunostomy tube |
Participants randomised to receive a feeding jejunostomy will be first
explained about the procedure, informed consent taken and posted for the
surgery after due pre anesthetic clearance. In the operation theatre,
participant would be anesthetised and in supine position. Upper abdomen
would be cleaned with sterile betadine solution & draped as per standard
protocol. A 4-5cm midline upper abdominal incision will be placed and
the abdomen will be opened in layers. Once within the peritoneal cavity,
duodenojejunal flexure will be identified and a 0.5cm opening will be
created in the jejunum 15-20cm distal to the duodenojejunal flexure. A
deroofed T tube will be utilised as the jejunostomy tube. It will be
inserted into the jejunal opening and purse-string sutures will be used to
fix the tube to the jejunum. Patency will be tested by free flow of fluid
through the tube. The free end of the tube will then be brought out
through a small opening in the left upper quadrant anterior abdominal
wall about 5cm away from midline. The tube will then be fixed to skin
using sutures and the jejunal loop intra-abdominally will be fixed to the
peritoneum adjacent to the site of exit of the tube. Patency of the tube
will be rechecked. Hemostasis will be ensured and abdominal wound will
be closed in layers. Cleaning & dressing of the wound will be done and
participant will be shifted out of the operation theatre after anesthestic
clearance. Feeding via tube would only be started after participant recovers
with bowel sounds present on auscultation, usually around postoperative
day 2 or 3. |
| Intervention |
Nasogastric tube feeding |
Participants randomised to receive nasogastric tube will be first explained
about the procedure, informed consent taken and made comfortable. An
appropriate sized nasogastric tube will be chosen based on participant’s size
and inserted through one of the nostrils after applying sufficient
lignocaine 2% gel on the tube. After insertion, the tube will be fixed to
the nose using plaster. Feeding via tube would only be started after
checking the position of the tube tip clinically (by auscultation of the
sound of gush of air pushed in) and radiologically (visualising the radioopaque
tube tip in the stomach in Xray) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with head & neck cancer undergoing
curative radiotherapy who require insertion of a feeding tube |
|
| ExclusionCriteria |
| Details |
1. Patients with head & neck cancer undergoing curative
radiotherapy who aren’t willing for insertion of a feeding tube
2. Patients with head & neck cancer undergoing radiotherapy on
outpatient basis
3. Patients who are critically ill |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare the mean weight loss and percentage of patients with head and neck cancer completing the course of curative radiotherapy who have been randomised to receive
nasogastric tube or feeding jejunostomy |
Baseline Weight checked prior to start of tube feeding and Weight checked at completion or discontinuation of radiotherapy at around less than or equal to six weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
06/07/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a randomised control study where patients with head & neck cancer undergoing curative radiotherapy will be randomised to get a nasogastric tube or a feeding jejunostomy for nutritional support prior to the start of radiotherapy. The two groups will be compared to study the effect of type of feeding procedure on completion of radiotherapy and weight loss. |