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Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy

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ClinicalTrials.gov Identifier: NCT02332928
Recruitment Status : Recruiting
First Posted : January 7, 2015
Last Update Posted : July 12, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Virginia Commonwealth University

December 16, 2014
January 7, 2015
July 12, 2017
March 25, 2015
August 31, 2018   (Final data collection date for primary outcome measure)
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.
Difference in Fatigue (as measured by the FACIT-Fatigue subscale) [ Time Frame: Up to 3 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.
Complete list of historical versions of study NCT02332928 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Level of agreement in reported fatigue scores when two different survey instruments are used to measure fatigue. [ Time Frame: Up to 6 months ]
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy
Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy: A Double Blind Placebo-Controlled Trial
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Breast Cancer - Female
  • 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).
  • 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).
  • 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).
    Intervention: Drug: Melatonin
  • 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).
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
142
112
August 31, 2019
August 31, 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact: Gwendolyn L Parker, MS, FNP 804-828-5090 ggparker@vcu.edu
Contact: Egidio T Del Fabbro, MD 804-828-9909 egidio.delfabbro@vcuhealth.org
United States
 
 
NCT02332928
MCC-12-08248
HM20003275 ( Other Identifier: IRB )
NCI-2015-00345 ( Registry Identifier: CTRP )
P30CA016059 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Virginia Commonwealth University
Virginia Commonwealth University
National Cancer Institute (NCI)
Principal Investigator: Egidio T Del Fabbro, MD Massey Cancer Center
Virginia Commonwealth University
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP