Comparison of effect of melatonin on sleep with control groups in cancer patients

Not yet recruiting

• Conditions: Neoplasms,

• Registration Number: CTRI/2023/07/055598
• Lead Sponsor: Vardhman mahavir medical college and Safdarjung hospital

Brief Summary

This study is prospective randomised comparative controlled trial where 70 participants will be randomly assigned a group given oral melatonin (M) and group given oral melatonin (P) of similar colour .

The patients will be instructed to take tablet every day for 14 days 2 hours before bed time.They will be evaluated with Pittsburg sleep quality index (PSQI) scale while visiting pain clinic or via telephone.Fatigue assessment will be done using fatigue assessment scale and sleep perception of caregivers will be assessed by SATED scale.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-20
• Study Start: 2023-07-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Participants of age 18.
• 65 years ,with any stage of head and neck cancer with sleep disturbances of more than one month.

Exclusion Criteria

• Patients already on sleep medication for more than 2 months.
• Pregnancy and lactation .
• Patient with history of psychiatric disorders .
• Patients with communication difficulties.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study effect of oral Melatonin on sleep quality and fatigue of cancer patients of head and neck region using Pittsburg sleep quality index scale	First and 14th day of oral melatonin

Secondary Outcome Measures

Name	Time	Method
To compare fatigue in cancer patients of head and neck region before and after giving oral melatonin by using fatigue assessment scale and to assess sleep perception of caregivers by SATED scale.	First and 14th day of oral melatonin

Trial Locations

Locations (1)

VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL; 🇮🇳 South, DELHI, India

VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL

🇮🇳South, DELHI, India

Pushpa

Principal investigator

9650709548

connectmbbs08@gmail.com