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

Comparison of effect of oral melatonin on sleep and fatigue with control groups in cancer patients of head and neck region

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055598
Enrollment
70
Registered
2023-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Oral melatonin (M)will be given to one group and oral melatonin (P) will be given to other group of similar colour: 70 patients will be assigned to groups given oral melatonin (M)or giv

Sponsors

Vardhman mahavir medical college and Safdarjung hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To study effect of oral Melatonin on sleep quality and fatigue of cancer patients of head and neck region using Pittsburg sleep quality index scaleTimepoint: First and 14th day of oral melatonin

Secondary

MeasureTime frame
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.Timepoint: First and 14th day of oral melatonin

Countries

India

Contacts

Public ContactPUSHPA

Vardhman mahavir medical college and Safdarjung hospital

drmadhudayal@gmail.com9811271996

Outcome results

None listed

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