| CTRI Number |
CTRI/2020/03/024269 [Registered on: 26/03/2020] Trial Registered Prospectively |
| Last Modified On: |
19/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to find out the effectiveness of Gabapentin on patients who develop pain due to oral mucositis while they are on chemo-radaition therapy with Head and Neck Cancers with the site of tumor at the following regions (oral & oropharynx versus larynx & hypopharynx). |
|
Scientific Title of Study
|
A randomized study to evaluate the effectiveness of Gabapentin on Oral-Mucositis induced pain due to chemo-radio therapy in patients with head and neck cancers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 3421 |
Protocol Number |
| Version 2.0 Dated 07/02/2020 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay M Patil |
| Designation |
Associate Professor, Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1110,
11 th Floor Homi bhabha Block Department of Medical Oncology,
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869382266 |
| Fax |
02224171734 |
| Email |
vijaypgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay M Patil |
| Designation |
Associate Professor, Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1110,
11 th Floor Homi bhabha Block Department of Medical Oncology,
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869382266 |
| Fax |
02224171734 |
| Email |
vijaypgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay M Patil |
| Designation |
Associate Professor, Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1110,
11 th Floor Homi bhabha Block Department of Medical Oncology,
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869382266 |
| Fax |
02224171734 |
| Email |
vijaypgi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
TATA MEMORIAL HOSPITAL DR E BORGES MARG PAREL
MUMBAI 400012 |
| Type of Sponsor |
Other [Government Hospital] |
|
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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 Vjiay Patil |
Tata Memorial Hospital |
DEPARTMENT OF MEDICAL ONCOLOGY, HOMI BHABHA
BLOCK, ROOM NO 204
DR E BORGES ROAD
PAREL MUMBAI
400012
MAHARASHTRA
Mumbai
MAHARASHTRA |
9869382266
02224171734
vijaypgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
Gabapentin |
All eligible subjects will be randomized in a 1:1 ratio to one of the following two treatment arms:
Arm A- local Anesthetic ( Benzocaine 20% w/w gel)+Tramadol.
Arm B- local Anesthetic ( Benzocaine 20% w/w gel)+Tramadol + Gabapentin
In Arm A -Tramadol - 50 mg TDS administered with or without food, and should be swallowed whole with sufficient fluid (e.g. a glass of water).
And in Arm B-Gabapentin Treatment typically will be started at 300mg once daily, escalating by 300mg per day until reaching 900mg daily (t.i.d). Thereafter, if required, the dose can be increased in 300mg/day increments every 2 to 3 days up to a maximum dose of 1800mg/day. Gabapentin will be administered with or without food, and should be swallowed whole with sufficient fluid (e.g. a glass of water). |
| Comparator Agent |
Tramadol |
All eligible subjects will be randomized in a 1:1 ratio to one of the following two treatment arms: Arm A- local Anesthetic ( Benzocaine 20% w/w gel)+Tramadol. Arm B- local Anesthetic ( Benzocaine 20% w/w gel)+Tramadol + Gabapentin In Arm A -Tramadol - 50 mg TDS administered with or without food, and should be swallowed whole with sufficient fluid (e.g. a glass of water). And in Arm B-Gabapentin Treatment typically will be started at 300mg once daily, escalating by 300mg per day until reaching 900mg daily (t.i.d). Thereafter, if required, the dose can be increased in 300mg/day increments every 2 to 3 days up to a maximum dose of 1800mg/day. Gabapentin will be administered with or without food, and should be swallowed whole with sufficient fluid (e.g. a glass of water). |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 70-years
2. Histologically or cytologically confirmed head and neck cancers receiving CTRT
3. Presence of radiation induced mucositis grade 1 or above
4. Pain related to mucositis on Visual analogue scale of 1 or more
5. ECOG PS 0-2
6. Normal haematological parameters
a. Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused)
7. Normal Liver functions
a. Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN-1.2 mg/dl) range and AST and ALT levels ≤ 2.5 × ULN ( AST/ALT <50 U/L) |
|
| ExclusionCriteria |
| Details |
1. Use of analgesic for more than 1 week X
2. Deranged serum creatinine > 1.5ULN
3. Known allergy to tramadol
|
|
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Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Objective is to Evaluate the Pain scores at baseline, post 1st dose of analgesic and at day 7 |
1. Pain score at baseline (on Visual analogue scale) and first dose of analgesic and at day 7 would be noted. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the rate of change or escalation of analgesic post 1 week of start of studied analgesic in the treatment of CTRT induced mucositis pain in patients with HNC. |
1. To compare the rate of change or escalation of analgesic post 1 week of start of studied analgesic |
| To compare the QOL week 1 post randomisation andat the end of CTRT between the 2 arms |
3. To compare the QOL week 1 post randomisation andat the end of CTRT between the 2 arms |
| To compare the compliance and adverse events |
After completion of treatment |
| Treatment delay |
After completion of treatment |
|
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Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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 |
|
Date of First Enrollment (India)
|
07/04/2020 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
In this study 154 head and neck cancer patients undergoing radical or adjuvant chemoradiation, who have grade 1 or above mucositis ( in accordance with CTCAE version 5.0) and have pain related to it would be randomly assigned to either Gabapentin or tramadol for mucositis related pain control. Pain score would be noted at baseline (on Visual analogue scale), postfirst dose of analgesic and at day 7. The area under the curve (AUC) will be calculated with the pain scores been plotted on Y axis and time points been plotted on X axis. The time scale will be adjusted for baseline with scale 0 and the other the time scales would be replaced by a numerical scale of 1, 2, 3, 4, 5, and 6 to avoid overweighting the later time points.The AUCs for the two treatment arms will be compared by using the Wilcoxon rank sum test with 95% CIs.The primary endpoint comparison of change of analgesic at 1 week postrandomisation. The secondary endpoints of this study are comparison of analgesia post administration of the studied analgesic post first dose ,to compare the QOL, compliance and adverse events at end of treatment. |