| CTRI Number |
CTRI/2012/11/003115 [Registered on: 16/11/2012] Trial Registered Prospectively |
| Last Modified On: |
16/11/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improvement in swallowing problems with early exercises in head and neck cancer patients. |
|
Scientific Title of Study
|
A comparative, randomized single blind prospective study to find out the impact of early dysphagia intervention on swallowing function in head and neck cancer patients treated with intensity modulated radiation therapy (IMRT) or image guided radiation therapy (IGRT)with or without chemotherapy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DI-HNC 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajender |
| Designation |
Attending Consultant |
| Affiliation |
Max super speciality hospital |
| Address |
Max super specialty hospital
2 press enclave road saket
South
DELHI
110017
India |
| Phone |
9911585358 |
| Fax |
|
| Email |
leo.rajender@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajender |
| Designation |
Attending Consultant |
| Affiliation |
Max super speciality hospital |
| Address |
Max super specialty hospital
2 press enclave road saket
DELHI
110017
India |
| Phone |
9911585358 |
| Fax |
|
| Email |
leo.rajender@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajender |
| Designation |
Attending Consultant |
| Affiliation |
Max super speciality hospital |
| Address |
Max super specialty hospital
2 press enclave road saket
DELHI
110017
India |
| Phone |
9911585358 |
| Fax |
|
| Email |
leo.rajender@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Specialty Hospital, saket |
|
|
Primary Sponsor
|
| Name |
Devki Devi Foundation |
| Address |
Max super speciality hospital
2 Press enclave road saket |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 rajender |
Max super specialty hospital a unit of Devki Devi |
2 press enclave road saket new delhi 110017
South
DELHI |
09911585358
leo.rajender@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
head and neck cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
clinical evaluation (not giving FEES) |
Dysphegia assessment with out FEES |
| Intervention |
FEES (Fiberoptic Endoscopic Evaluation of Swallowing)
|
Dysphagia assessment (clinical evaluation + FEES) with the intervention
Swallowing assessment (Dysphegia Assessment) will be done three times for each patient, in the 1st week, after 3 & 6 months of radiation. Patient will come for routine follow up as per departmental policy at 2 weeks, 1, 3 & 6 months after completion of radiation. Patients will be reinforced to continue regular dysphagia exercises, at least twice a day and 4 days in a week. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
1. Patients 19 to 85 years of age, either sex.
2. Head & Neck sites (Nasopharynx, Oral Cavity, Oropharynx, Hypopharynx, Larynx)
3. Confirmed histopathological diagnosis
4. Must undergo pre-treatment evaluation of tumor extent and tumor measurement.
5. Nutritional and general physical condition must be considered compatible with treatment
6. No prior radiotherapy to the head and neck; no previous chemotherapy
7. No prophylactic use of amifostine or pilocarpine
8. No other malignancy in the rest of the body
9. No evidence of distant metastasis
10. No major medical or psychiatric illness
|
|
| ExclusionCriteria |
| Details |
1. Patients having tracheostomy tube
2. Second malignancy of head and neck region
3. Previously radiated patients
4. Psychiatric and neurological conditions involving brain and cervical spine
5. Unable to comprehend the function and use of the rehabilitation exercises
6. Patient not agreeing for follow up.
7. Swallowing problem other than due to malignancy.
8. Age > 65 and < 18 Years
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Head and neck cancer patients with or without dysphagia . |
Head and neck cancer patients with or without dysphagia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
12/12/2012 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
After completion the Trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study
Title
Title of the study: Randomized prospective study to find out the impact of
early dysphagia intervention on swallowing function in head and neck cancer
patients treated with intensity modulated radiation therapy (IMRT) or image guided radiation therapy
(IGRT)with or without chemotherapy
Objectives
To find out the impact of early dysphagia intervention on
swallowing function
Design and Outcome
This
study is a randomized Prospective study where Head and neck cancer patients will
be randomly allocated to either of the groups with or without dysphagia intervention.
Interventions and duration
GROUP A-Dysphagia
assessment (clinical evaluation + FEES) with the intervention will be provided
from the day of the onset of radiation therapy.
GROUP
B – Dysphagia assessment (clinical evaluation + FEES) without the intervention
will be provided from the day of the onset of radiation therapy.
Swallowing
assessment will be done three times for each patient, in the 1st
week, after 3 & 6 months of radiation. Patient will come for routine follow
up as per departmental policy at 2 weeks, 1, 3 & 6 months after completion
of radiation. Patients will be reinforced to continue regular dysphagia
exercises, at least twice a day and 4 days in a week.
Radiation
will be delivered with IMRT or IGRT, 5 days a week for 6-7 weeks along with or
without concurrent chemotherapy.
Sample size and Population
50 Head and neck cancer patients, 25 patients group A &
25 patients in group B. |