Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 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 AEs will be followed until resolution or stabilization of the adverse event.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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). |
Drug: 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).
|
| Placebo Comparator: 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). |
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).
|
Outcome Measures
Primary Outcome Measures
- Difference in Fatigue per Participant (as measured by the FACIT-Fatigue subscale) [Up to 4 months]
To determine whether the average increase in fatigue (as measured by the FACIT-Fatigue subscale) from baseline to completion of RT is different in those patients who received melatonin than in those who received placebo. FACIT Fatigue Scale is 13 questions on fatigue with 0 (not at all) and 4 (very much). Scores at baseline will be compared to scores at completion of radiation therapy.
Secondary Outcome Measures
- Average increase in health-related quality of life (HRQOL) from baseline to completion of RT in those patients who received melatonin compared to those who received placebo. [Up to 4 months]
- Average increase in fatigue from baseline until 2 weeks and 8 weeks after completion of RT in those patients who received melatonin compared to those who received placebo. [Up to 6 months]
- Average increase in symptoms from baseline until completion of RT for those patients who received melatonin compared to those who received placebo. [Up to 4 months]
- Average increase in fatigue (as measured by the PROMIS Fatigue-Short Form 8a) from baseline to completion of RT is less in those patients who received melatonin compared to those who received placebo. [Up to 6 months]
- Level of agreement per participant in reported fatigue scores when two different survey instruments are used to measure fatigue. [Up to 6 months]
- The number of hospital admissions, emergency center visits, and medical days off work between patients receiving melatonin compared to placebo. [Up to 6 months]
Eligibility Criteria
Criteria
Inclusion Criteria
-
Ambulatory outpatients with breast (including ductal carcinoma in situ [DCIS]) cancer.
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Patients to be treated with RT for curative intent.
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Women ≥18 years of age.
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ECOG performance status <3 (Appendix 4).
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Hemoglobin ≥ 9 g/dL
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Either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control during study treatment and for 3 months afterwards.
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Subjects who are currently taking melatonin must discontinue melatonin for 5 days before enrolling in the study.
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Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Fatigue brought on by conditions other than cancer such as (the indicated tests are required only if that mechanism of fatigue is suspected):
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uncontrolled hypothyroidism (TSH >10 IU)
-
hypercalcemia (calcium >11 mg/dL) Ca = SerumCa + 0.8 * (NormalAlbumin - PatientAlbumin)
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decompensated congestive heart failure
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chronic obstructive pulmonary disease requiring oxygen replacement
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Patients with a creatinine clearance <30 mL/min
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Aspartate aminotransferase (AST) > 3X upper limit of normal (ULN)
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Alanine aminotransferase (ALT) > 3X ULN
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Bilirubin > 1X ULN
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Use of systemic steroids, or other pharmacological agents such as methylphenidate for cancer-related fatigue
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Current use of American ginseng, remelteon, or warfarin.
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Depression ≥ grade 2 (CTCAE v4.0)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Alfredo I Urdaneta, MD, Massey Cancer Center
Study Documents (Full-Text)
More Information
Publications
None provided.- MCC-12-08248
- HM20003275
- NCI-2015-00345
- P30CA016059