| CTRI Number |
CTRI/2024/12/078565 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to know the use of laser light therapy to reduce neck stiffness caused by radiation therapy in patients with head and neck cancer |
|
Scientific Title of Study
|
A study on use of photobiomodulation for mitigating radiation induced neck fibrosis among patients with head and neck cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rachita Gururaj |
| Designation |
Junior Research Fellow |
| Affiliation |
M. S. Ramaiah College of Physiotherapy |
| Address |
Third floor, M. S. Ramaiah College of Physiotherapy, Ramaiah Medical College Hospital, M. S. Ramaiah University of Applied Sciences, MSR Nagar, MSRIT Post, New BEL Road, Bengaluru.
Bangalore
KARNATAKA
560054
India |
| Phone |
9741127717 |
| Fax |
|
| Email |
rachitagururaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Sundar Kumar |
| Designation |
Associate Professor |
| Affiliation |
M. S. Ramaiah College of Physiotherapy |
| Address |
Third floor, M. S. Ramaiah College of Physiotherapy, Ramaiah Medical College Hospital, M. S. Ramaiah University of Applied Sciences, MSR Nagar, MSRIT Post, New BEL Road, Bengaluru.
Bangalore
KARNATAKA
560054
India |
| Phone |
9739468755 |
| Fax |
|
| Email |
sundar.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Sundar Kumar |
| Designation |
Associate Professor |
| Affiliation |
M. S. Ramaiah College of Physiotherapy |
| Address |
Third floor, M. S. Ramaiah College of Physiotherapy, Ramaiah Medical College Hospital, M. S. Ramaiah University of Applied Sciences, MSR Nagar, MSRIT Post, New BEL Road, Bengaluru.
Bangalore
KARNATAKA
560054
India |
| Phone |
9739468755 |
| Fax |
|
| Email |
sundar.rcp@msruas.ac.in |
|
|
Source of Monetary or Material Support
|
| The study would be self funded. The infrastructure support would be provided by M. S. Ramaiah Medical College Hospital, Bengaluru, Karnataka, India- 560054 |
|
|
Primary Sponsor
|
| Name |
Rachita Gururaj |
| Address |
Third floor, M. S. Ramaiah College of Physiotherapy, Ramaiah Medical College Hospital, M. S. Ramaiah University of Applied Sciences, MSR Nagar, MSRIT Post, New BEL Road, Bengaluru, Karnataka, India- 560054 |
| 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 |
| Dr V Sundar Kumar |
M. S. Ramaiah Medical College Hospital |
Third floor, M. S. Ramaiah College of Physiotherapy, Ramaiah Medical College Hospital, M. S. Ramaiah University of Applied Sciences, MSR Nagar, MSRIT Post, New BEL Road, Bengaluru. 560054
Bangalore
KARNATAKA |
9739468755
sundar.rcp@msruas.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Ramaiah Medical College |
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 |
| Intervention |
Photobiomodulation |
In addition to standard care, PBMT would be delivered over the sternocleidomastoid muscle region bilaterally on the days of radiotherapy. Based on World Association for Photobiomodulation Therapy guidelines, an energy dose of two Einstein will be delivered to the target site. The treatment time would be calculated based on the area of treatment for each participant and would be in the range of 10-30 minutes.
PBMT would be delivered during the course of radiation therapy (about 6-8 weeks, as decided by the radiation oncologist.)
Each side would receive PBMT on alternative days. |
| Comparator Agent |
Standard care |
Participants in standard care group will be taught to perform neck range of motion exercises, neck muscle stretches and mouth opening exercises. Participants will also be given a booklet explaining exercise type, frequency, and general precautions.
Participants would also receive placebo PBMT (masked by goggles) for a duration similar to the intervention arm through the course of radiation therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
• Patients diagnosed with head and cancer
• Patients planned for radiotherapy (radical/ concurrent/ adjuvant)
• Patients consenting for participation in the study |
|
| ExclusionCriteria |
| Details |
• Patients with recurrent disease
• Patients with surgical resection of sternocleidomastoid muscle
• Patients with active disease in the area exposed to PBMT delivery
• Patients planned for palliative radiotherapy
• Patients with tattoos in the region of Photobiomodulation therapy
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Fibrosis severity
• Shear wave elastography of the bilateral sternocleidomastoid muscle
• LENT SOMA Scale
2. Neck range of motion assessment
• Goniometry (Angles)
• Tape measurements (Distance)
3. Quality of life
• Functional Assessment of Cancer Therapy- Head and Neck Questionnaire |
1. At baseline
2. Follow up: three, six, nine and 12 months post completion of radiation therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiation dermatitis (CTCAE) |
At the last day of radiation therapy |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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 Yet Recruiting |
| 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
|
Lay summary:
Radiation therapy can cause long-term neck stiffness and scarring, known as neck fibrosis, which affects movement and quality of life. A treatment called photobiomodulation therapy (PBMT) uses low-level laser light to reduce side effects of radiation therapy, but most studies only track short-term results (4–6 weeks). This study aims to test if PBMT can help prevent or reduce neck fibrosis over a longer period (12 months). The study will include patients receiving radiation therapy for head and neck cancer. Participants will be randomly divided into two groups: one receiving standard care (neck, mouth exercises and education booklet) and the other receiving standard care plus PBMT. PBMT will be applied to neck muscles during radiation therapy, and participants will be assessed before treatment and at 3, 6, 9, and 12 months after radiation therapy. Researchers will measure neck movement, scarring severity, and quality of life to compare the two groups. This study could provide valuable evidence about the long-term benefits of PBMT for managing neck fibrosis. |