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Melatonin as a Circadian Clock Regulator, Neuromodulator and Myelo-protector in Adjuvant Breast Cancer Chemotherapy

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Completed
CT.gov ID
NCT03205033
Collaborator
(none)
36
Enrollment
2
Arms
12
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Breast cancer is the second most common cancer in the world, the most common in women, representing the leading cause of death in Brazil. The therapeutic approach for breast cancer includes surgery, radiotherapy, chemotherapy and endocrine therapy. Chemotherapy courses with side effects because the cytotoxic effects affect indistinctly neoplastic cells and normal cells. The cancer per se may promote disruption in circadian rhythm. Chemotherapy induces or enhances desynchronization of the sleep-wake cycle, which competes with impaired memory, mood, pain and poor quality of life. Melatonin is an attractive therapeutic option in this context. This neurohormone also has immunomodulatory, co-analgesic and anti-depressant properties. Additionally, the antioxidant properties of melatonin may decrease free radical formation, reducing damage to DNA. The objective is to assess the response to melatonin as a synchronizer of the sleep-wake rhythm, neuromodulator, and mieloprotetor genoprotetor in the effects induced by chemotherapy in women with breast cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: Melatonin 20 MG Oral Capsule
  • Drug: Placebo oral capsule
 Phase 2

Detailed Description

This is a randomized, double-blind clinical trial, parallel, placebo-controlled trial. Breast cancer women treated surgically and with indication for adjuvant chemotherapy, aged between 18 and 75 years will be included. Patients will be randomized to receive 20mg of melatonin or placebo at bedtime. Treatment will initiate seven days before the start of chemotherapy to three days after the first cycle, totaling ten days. The sleep-wake rhythm will be assessed by actigraphy, which use will precede three days to start treatment. We will also evaluate the sleep-wake cycle by sleep diary. Other parameters will be measured as depressive symptoms, pain threshold pressure, effect on platelets and white series, the pain response to conditioned stimuli and quality of life. Serum markers of neuroplasticity will be measured as the Derivate Nerve Factor Brain BDNF and S100 β. The icronucleus effect will quantified by cell material from the oral mucosa. We expect that the use of melatonin, as a competitor to chemotherapy and synchronizer, improves tolerance to adjuvant treatment of breast cancer chemotherapy adverse effects.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Melatonin as a Circadian Clock Regulator, Neuromodulator and Myelo-protector in Adjuvant Breast Cancer Chemotherapy: a Randomized, Double-blind, Placebo-controlled Trial.
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Melatonin

Melatonin 20 mg Oral Capsules, once a day at bedtime

Drug: Melatonin 20 MG Oral Capsule
1 capsule/day 1 hour before go to bed
Other Names:
  • MTN

    		•
    Placebo Comparator: Placebo

    Placebo Oral Capsules, once a day at bedtime

    Drug: Placebo oral capsule
    1 capsule/day 1 hour before go to bed
    Other Names:
  • PCB

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the response to melatonin as a sleep-wake rhythm synchronizer on the effects induced by chemotherapy in women with breast cancer. [1 capsule of melatonin 20 mg or Placebo capsule, once a day, 1 hour before go to bed]

      Actigraphy to assess the circadian rhythm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female

    • Diagnosed with breast cancer

    • Indicated for the adjuvant treatment for breast cancer

    • Between 18 years and 75 years

    • Alphabetized

    Exclusion Criteria:

    • Undergone chemotherapy or radiotherapy before inclusion in the study.

    • Pregnant

    • Epilepsy

    • Brain Stroke

    • Multiple sclerosis

    • BMI above 45 kg / m 2

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hospital de Clinicas de Porto Alegre

    Investigators

    • Principal Investigator: Wolnei Caumo, PhD, Hospital de Clínicas de Porto Alegre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital de Clinicas de Porto Alegre
    ClinicalTrials.gov Identifier:
    NCT03205033
    Other Study ID Numbers:
    • 14-0701
    First Posted:
    Jul 2, 2017
    Last Update Posted:
    Jul 2, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hospital de Clinicas de Porto Alegre
    Melatonin
    Breast cancer
    Chemotherapy
    Sleep-wake rhytms
    Circadian rhythms
    Additional relevant MeSH terms:
    Sleep Wake Disorders
    Sleep Disorders, Circadian Rhythm
    Melatonin

    Study Results

    No Results Posted as of Jul 2, 2017