To see whether advice about sleeping practices along with medicines can reduce sleeplessness in patients with cancer receiving treatment

Modified Cognitive Behavioural Therapy -I (MCBT-I) with melatonin for acute insomnia in patients undergoing chemotherapy: A Double Blind Randomised Controlled Trial (COMET) - COMET

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071467

Enrollment

140

Registered

2024-07-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G470- Insomnia

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Already on anti insomnia medication known psychiatric illnesses Known sleep disorders on medications patients with hematological cancers Primary brain tumors or brain metastasis

Design outcomes

Primary

Measure	Time frame
Insomnia status assessed by the ISI scoreTimepoint: Insomnia status assessed by the ISI score	—

Secondary

Measure	Time frame
Quality of lifeTimepoint: 6 weeks;Symptom severity scoreTimepoint: 6 weeks	—

Countries

India

Contacts

Public ContactDr Muthuveerappan S

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

pg1980@gmail.com9444216310

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026