| CTRI Number |
CTRI/2023/01/049171 [Registered on: 24/01/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
exercise therapy during radiotherapy to improve quality of life in head and neck cancer. |
Scientific Title of Study
Modification(s)
|
A randomized clinical study to evaluate the effect of exercise therapy during ongoing radiotherapy to improve mouth opening and quality of life in patients with head and neck cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOUMYAJIT MANDAL |
| Designation |
MPT (MUSCULOSKELETAL) |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9091943875 |
| Fax |
|
| Email |
soumyajitmandal2204@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AKSH CHAHAL |
| Designation |
PROFESSOR |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, MM(DU),Department of sport physiotherapy, room number 5
Ambala
HARYANA
133207
India |
| Phone |
9711774174 |
| Fax |
|
| Email |
drakshchahal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr DEEPIKA MALIK |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences & Research |
| Address |
Maharishi Markandeshwar Institute of Medical Sciences & Research, MM(DU),Department of Radiotherapy room no 3
Ambala
HARYANA
133207
India |
| Phone |
8600033246 |
| Fax |
|
| Email |
drdeepikamalik36@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar Deemed to be University,
Mullana, Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
SOUMYAJIT MANDAL |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, MM(DU), Mullana, Ambala |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| SOUMYAJIT MANDAL |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Department of Musculoskeletal Physiotherapy, OPD-1
Ambala
HARYANA |
9091943875
soumyajitmandal2204@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe of Maharishi Markandeshwar Institute of medical science and research (Deemed to be university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intensive exercise by
wooden tongue depressors
|
The patient is asked to place 3 wooden sticks into the mouth hold it, Twice a day for two days per week for 4 weeks |
| Intervention |
Stretching exercise by hester
jaw opening device
|
The patient is asked to place the hester jaw opening device in the mouth, Twice a day for two days per week for 4 weeks |
| Intervention |
Warm-up Exercise |
Warm-up (exercises to enhance joint lubrication): 10 times mouth opening and closing, 10 times right lateral excursion, 10 times left lateral and 10 times mandibular protrusion Twice a day for two days per week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants are willing to participate.
2. Histologically proven Squamous Cell Carcinoma of oral cavity, oropharynx, hypopharynx, and larynx.
3. Stage II-IV by AJCC Cancer Staging Manual Eighth Edition, 2017.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or less.
5. Age group between 18 to 70 years. |
|
| ExclusionCriteria |
| Details |
1. Any Pre- existing diagnosed neurological condition.
2. History of pervious Radiotherapy to the head and neck region.
3. Initial mouth opening less than 10mm.
4. patients taking any physiotherapy or speech therapy treatment for trismus. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mouth Opening measure by Digital vernier caliper. |
At baseline and after 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life measure by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN35) |
At baseline and after 4 week |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
24/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/01/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Ethical approval of this study was taken from the
institutional Ethical Committee of Maharishi Markandeshwar (Deemed to be
University), Mullana,(MMDU/IEC/2227). It will be done by Helsinki declaration
revised in 2013 and National Ethical Guidelines for Biomedical Research
involving Human participants, 2017. Difficulty in mouth
opening is a common problem in patients with Head Neck Cancer(HNC). There are
therapeutic interventions for HNC. This study has been planned to evaluate the
effect of exercise therapy during ongoing radiotherapy to improve mouth opening
and quality of life in patients with HNC.
|