Richmond, Virginia 23298


Purpose:

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.


Study summary:

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.


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)


Study is Available At:


Original ID:

MCC-12-08248


NCT ID:

NCT02332928


Secondary ID:

HM20003275


Study Acronym:


Brief Title:

Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy


Official Title:

Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy: A Double Blind Placebo-Controlled Trial


Overall Status:

Recruiting


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Virginia Commonwealth University


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

142


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Egidio T Del Fabbro, MD
Principal Investigator
Massey Cancer Center
Primary Contact:Gwendolyn L Parker, MS, FNP
804-828-5090
ggparker@vcu.edu
Backup Contact:Egidio T Del Fabbro, MD
804-828-9909
egidio.delfabbro@vcuhealth.org

Study Dates

Start Date:March 25, 2015
Completion Date:August 31, 2024
Completion Type:Anticipated
Primary Completion Date:August 31, 2023
Primary Completion Type:Anticipated
Verification Date:October 2019
Last Changed Date:October 31, 2019
First Received Date:December 16, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Difference in Fatigue (as measured by the FACIT-Fatigue subscale)
Time Frame:Up to 4 months
Safety Issues:False
Description: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 question
Outcome Type:Secondary Outcome
Measure: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.
Time Frame:Up to 4 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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.
Time Frame:Up to 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Average increase in symptoms from baseline until completion of RT for those patients who received melatonin compared to those who received placebo.
Time Frame:Up to 4 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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.
Time Frame:Up to 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Level of agreement in reported fatigue scores when two different survey instruments are used to measure fatigue.
Time Frame:Up to 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The number of hospital admissions, emergency center visits, and medical days off work between patients receiving melatonin compared to placebo.
Time Frame:Up to 6 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Melatonin
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).
Arm Name:20 mg Melatonin
Intervention Type:Drug
Name:Placebo
Description: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).
Arm Name:Placebo

Study Arms

Study Arm Type:Active Comparator
Arm Name:20 mg Melatonin
Description: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).
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description: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).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Virginia Commonwealth University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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