Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy
Condition: Breast Cancer - Female
MeSH terms: Fatigue
Intervention: Melatonin; Placebo
Intervention description: 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) (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 MeSH terms: Melatonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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)