Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy

• Status: Completed
• Trial end date: 2021-06-02
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Melatonin; Polystyrene sulfonic acid

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. 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) Ca = 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)