| CTRI Number |
CTRI/2024/04/065944 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study is checking if putting methylene blue directly on the mouth sores caused by radiation can make the pain feel better, but its not comparing it to anything else. |
|
Scientific Title of Study
|
Assessing topical methylene blue efficacy for radiation-induced oral mucositis pain: a single arm phase ii clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navas Bright |
| Designation |
DNB Student |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Pain and Palliative department,
Cancer Institute (W.I.A)
No. 38, sardar patel road
Adyar, chennai -36.
Pain and Palliative department,
Cancer Institute (W.I.A)
No. 38, sardar patel road
Adyar, chennai -36
044-22351615
Chennai
TAMIL NADU
600036
India |
| Phone |
9061690691 |
| Fax |
|
| Email |
navas09090@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi VV |
| Designation |
Associate Professor |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Anaesthesiology, Pain and Palliative care,
Cancer Institute (W.I.A)
No. 38, sardar patel road
Adyar, chennai -36.
Anaesthesiology, Pain and Palliative care,
Cancer Institute (W.I.A)
No. 38, sardar patel road
Adyar, chennai -36
044-22351615
Chennai
TAMIL NADU
600036
India |
| Phone |
9940370735 |
| Fax |
|
| Email |
meenaram99@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Navas Bright |
| Designation |
DNB Student |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Cancer Institute (W.I.A)
No. 38, sardar patel road
Adyar, chennai -36.
Cancer Institute (W.I.A)
No. 38, sardar patel road
Adyar, chennai -36
044-22351615
Chennai
TAMIL NADU
600036
India |
| Phone |
9061690691 |
| Fax |
|
| Email |
navas09090@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cancer Institute (W.I.A)
No. 38, sardar patel road
Adyar, chennai -36. |
| NIL |
|
|
Primary Sponsor
|
| Name |
Navas Bright |
| Address |
Cancer Institute
No. 38, sardar patel road
Adyar, chennai -600036
044-22351615 |
| Type of Sponsor |
Other [principal investigator] |
|
|
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 |
| Navas Bright |
Cancer Institute (WIA) |
Department of pain and palliative care
Cancer Institute (W.I.A)
No. 38, sardar patel road
Adyar, chennai -36
044-22351615
Chennai
TAMIL NADU |
9061690691
navas09090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Cancer Institute (wia), Institutional Ethics Committee- NABH Accredited |
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 |
ASSESSING TOPICAL METHYLENE BLUE EFFICACY FOR RADIATION-INDUCED ORAL MUCOSITIS PAIN: A SINGLE ARM PHASE II CLINICAL TRIAL |
In instances where patients report a pain score greater than 4 and consenting to study, they will be provided with a 10 ml solution containing 0.025% methylene blue for a 5-minute rinse and gargle to be repeated every 6 hours for 2 weeks. After each use, the patient will be asked not take anything orally for the next 30 minutes. The Numerical Rating Scale (NRS) and Harris Oral Mucositis assessment will be conducted both before and 1 hour after the initial use, followed by once daily assessments for the subsequent two weeks. Then for 2 weeks for residual effects. Patient without adequate pain relief after first use of oral methylene blue will be given oral analgesics.
Patient with pain score of more than 6, at initial assessment will be given oral/intravenous analgesics as per WHO analgesic ladder.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 18 years
2. Oral cavity and oropharynx cancer patients
receiving radiation or chemoradiation
3. Oral cavity pain with NRS ≥4 and not on
analgesic for oral pain.
4. Pain score more ≥7, with or without
analgesia for oral pain
5. Any grade of oral mucositis
6. All stages of cancer with cancer-related
pain adequately controlled before radiation
7. Voluntary written consent.
|
|
| ExclusionCriteria |
| Details |
1.Oro-cutaneous fistula
2.Inability to rinse/gargle/no mouth opening
3Known allergy to methylene blue
4.Cognitive impairment and inability to
consent
5.Confused/ agitated patient
6.Patient with cognitive impairment
7.Patients undergoing re-radiation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate pain relief with topical methylene blue 0.025% in patients with radiation-induced oral mucositis. |
baseline, 1st hour, every day once for 2 weeks,then alternate day for 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Oral functioning of the patient with radiation induced OM on methylene blue rinse.
2.Dose of systemic analgesics and adjuvants in patients receiving methylene blue.
3. Side effects of methylene blue on topical use for oral mucositis.
|
Four weeks of starting intervention. |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
26/04/2024 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Radiation is one of
the primary treatments for head and neck cancer, but it also contributes to
mucositis, resulting in pain and a diminished quality of life. Pain management
typically involves the use of topical agents and systemic opioids. The
rationale for this study is to investigate the effectiveness of a novel topical
agent, methylene blue, in alleviating pain caused by radiation-induced
mucositis, with the ultimate goal of reducing the need of systemic opioids.
|