Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy

NCT ID: NCT02332928

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-25
• Study Completion Date: 2021-06-02

Brief Summary

This is a double-blind, placebo-controlled trial wherein subjects with breast cancer will be randomized to receive either 20 mg oral melatonin or placebo the night before their first radiotherapy (RT), nightly throughout their RT, and for an additional 2 weeks following the completion of their RT. After informed consent is obtained from eligible subjects, they will then be electronically randomized on a 1:1 ratio to melatonin treatment or placebo. The subjects will be stratified according to treatment duration (less than 3 weeks; equal to or greater than 3 weeks) and prior chemotherapy.

Detailed Description

Subjects will be randomized to receive either melatonin or placebo. Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT. Patients with localized breast cancer will receive standard-of-care RT as determined by the treating physician. The RT regimens include: (1) 1 week of accelerated (APBI); (2) 3-4 weeks of an accelerated hypofractionation RT schedule; and (3) 6-8 weeks of a standard RT schedule. No additional concomitant medication or supportive care guidelines are required for this study. Subjects will receive daily melatonin or placebo beginning the night before their course of RT and for an additional 2-week period that extends beyond the conclusion of their RT. Subjects will be given a Study Diary to record their use of study medication. Patients will be followed for 60 days after removal from the study treatment or until death, whichever occurs first. Patients removed from the study treatment for unacceptable adverse events (AEs) will be followed until resolution or stabilization of the adverse event.

Conditions

Breast Cancer - Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

20 mg Melatonin

RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).

Group Type: ACTIVE_COMPARATOR

Melatonin

Intervention Type: DRUG

Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).

Placebo

RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).

Interventions

Melatonin

Melatonin + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).

Intervention Type: DRUG

Placebo

Placebo + RT (as clinically indicated) (Subjects will receive 20-mg oral melatonin or placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ambulatory outpatients with breast (including ductal carcinoma in situ [DCIS]) cancer.

2. Patients to be treated with RT for curative intent.

3. Women ≥18 years of age.

4. Eastern Cooperative Oncology Group (ECOG) performance status <3 (Appendix 4).

5. Hemoglobin ≥ 9 g/dL

6. Either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control during study treatment and for 3 months afterwards.

7. Subjects who are currently taking melatonin must discontinue melatonin for 5 days before enrolling in the study.

8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Fatigue brought on by conditions other than cancer such as (the indicated tests are required only if that mechanism of fatigue is suspected):

• uncontrolled hypothyroidism (TSH >10 IU)
• hypercalcemia (calcium >11 mg/dL) Calcium (Ca) = Serum Calcium (SerumCa) + 0.8 * (NormalAlbumin - PatientAlbumin)
• decompensated congestive heart failure
• chronic obstructive pulmonary disease requiring oxygen replacement

2. Patients with a creatinine clearance <30 mL/min

3. Aspartate aminotransferase (AST) > 3X upper limit of normal (ULN)

4. Alanine aminotransferase (ALT) > 3X ULN

5. Bilirubin > 1X ULN

6. Use of systemic steroids, or other pharmacological agents such as methylphenidate for cancer-related fatigue

7. Current use of American ginseng, remelteon, or warfarin.

8. Depression ≥ grade 2 (CTCAE v4.0)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfredo I Urdaneta, MD

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Locations

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HM20003275

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2015-00345

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA016059

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-12-08248

Identifier Type: -

Identifier Source: org_study_id