| CTRI Number |
CTRI/2024/07/071467 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To see whether advice about sleeping practices along with medicines can reduce sleeplessness in patients with cancer receiving treatment |
|
Scientific Title of Study
|
Modified Cognitive Behavioural Therapy -I (MCBT-I) with melatonin for acute insomnia in patients undergoing chemotherapy: A Double Blind Randomised Controlled Trial (COMET) |
| Trial Acronym |
COMET |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasanth Ganesan |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Medical oncology, 3rd Floor SSB
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9444216310 |
| Fax |
|
| Email |
pg1980@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanth Ganesan |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Medical oncology, 3rd Floor SSB
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9444216310 |
| Fax |
|
| Email |
pg1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muthuveerappan S |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Medical oncology, 3rd Floor
Super specialty block
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9500595396 |
| Fax |
|
| Email |
muthuveerappan100796@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research, Jipmer Campus, Gorimedu, Dhanvantari nagar, Puducherry, 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Muthuveerappan S |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
Department of Medical Oncology, 3rd Floor, SS Block JIPMER Campus, Dhanvanthri Nagar, Gorimedu
Pondicherry
PONDICHERRY |
9500595396
muthuveerappan100796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
modified cognitive behaviour therapy with melatomin |
patients will receive 2 sessions of modified cognitive behaviour therapy. In addition they will receive tablet melatonin starting at 3 mg and increasing to 6 mg as required over a period of 42 days. |
| Comparator Agent |
modified cognitive behaviour therapy with placebo |
patients will receive 2 sessions of modified cognitive behaviour therapy. In addition they will receive tablet placebo 42 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of cancer
On curative chemotherapy beyond cycle 1
Insomnia as per scale of at least 15
Presence of insomnia after cycle 1 within 4 weeks prior to enrolment
Normal organ function
able to understand tamil or english |
|
| ExclusionCriteria |
| Details |
Already on anti insomnia medication
known psychiatric illnesses
Known sleep disorders on medications
patients with hematological cancers
Primary brain tumors or brain metastasis |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Insomnia status assessed by the ISI score |
Insomnia status assessed by the ISI score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
6 weeks |
| Symptom severity score |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
31/07/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
This is a study to be done in patients undergoing chemotherapy for cancer and suffering from sleeplessness (Insomnia). Eligible patients will receive cognitive behavior therapy. In addition, they will be randomised to 2 groups. One group will receive melatonin for 6 weeks while the other group will receive placebo for 6 weeks. The end point will be improvement in insomnia severity after 6 weeks. This trial will try to see whether addition of melatonin to behaviour therapy will reduce insomnia. |