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Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy

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ClinicalTrials.gov Identifier: NCT02332928
Recruitment Status : Active, not recruiting
First Posted : January 7, 2015
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Virginia Commonwealth University

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
Breast Cancer - Female Drug: Melatonin Drug: Placebo 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy: A Double Blind Placebo-Controlled Trial
Actual Study Start Date : March 25, 2015
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
Drug Information available for: Melatonin

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).




Primary Outcome Measures :
  1. Difference in Fatigue (as measured by the FACIT-Fatigue subscale) [ Time Frame: 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Level of agreement in reported fatigue scores when two different survey instruments are used to measure fatigue. [ Time Frame: Up to 6 months ]
  6. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332928


Locations
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Egidio T Del Fabbro, MD Massey Cancer Center

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02332928     History of Changes
Other Study ID Numbers: MCC-12-08248
HM20003275 ( Other Identifier: IRB )
NCI-2015-00345 ( Registry Identifier: CTRP )
P30CA016059 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants