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

Primary Purpose

Sleep Disorders, Circadian Rhythm, Depression, Genotoxicity

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Melatonin 20 MG Oral Capsule
Placebo oral capsule
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders, Circadian Rhythm focused on measuring Melatonin, Breast cancer, Chemotherapy, Sleep-wake rhytms, Circadian rhythms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Melatonin

    Placebo

    Arm Description

    Melatonin 20 mg Oral Capsules, once a day at bedtime

    Placebo Oral Capsules, once a day at bedtime

    Outcomes

    Primary Outcome Measures

    To evaluate the response to melatonin as a sleep-wake rhythm synchronizer on the effects induced by chemotherapy in women with breast cancer.
    Actigraphy to assess the circadian rhythm

    Secondary Outcome Measures

    Full Information

    First Posted
    June 28, 2017
    Last Updated
    June 28, 2017
    Sponsor
    Hospital de Clinicas de Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03205033
    Brief Title
    Melatonin as a Circadian Clock Regulator, Neuromodulator and Myelo-protector in Adjuvant Breast Cancer Chemotherapy
    Official Title
    Melatonin as a Circadian Clock Regulator, Neuromodulator and Myelo-protector in Adjuvant Breast Cancer Chemotherapy: a Randomized, Double-blind, Placebo-controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital de Clinicas de Porto Alegre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Disorders, Circadian Rhythm, Depression, Genotoxicity, Pain
    Keywords
    Melatonin, Breast cancer, Chemotherapy, Sleep-wake rhytms, Circadian rhythms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Melatonin
    Arm Type
    Active Comparator
    Arm Description
    Melatonin 20 mg Oral Capsules, once a day at bedtime
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Oral Capsules, once a day at bedtime
    Intervention Type
    Drug
    Intervention Name(s)
    Melatonin 20 MG Oral Capsule
    Other Intervention Name(s)
    MTN
    Intervention Description
    1 capsule/day 1 hour before go to bed
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo oral capsule
    Other Intervention Name(s)
    PCB
    Intervention Description
    1 capsule/day 1 hour before go to bed
    Primary Outcome Measure Information:
    Title
    To evaluate the response to melatonin as a sleep-wake rhythm synchronizer on the effects induced by chemotherapy in women with breast cancer.
    Description
    Actigraphy to assess the circadian rhythm
    Time Frame
    1 capsule of melatonin 20 mg or Placebo capsule, once a day, 1 hour before go to bed

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wolnei Caumo, PhD
    Organizational Affiliation
    Hospital de Clínicas de Porto Alegre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31824318
    Citation
    Palmer ACS, Souza A, Dos Santos VS, Cavalheiro JAC, Schuh F, Zucatto AE, Biazus JV, Torres ILDS, Fregni F, Caumo W. The Effects of Melatonin on the Descending Pain Inhibitory System and Neural Plasticity Markers in Breast Cancer Patients Receiving Chemotherapy: Randomized, Double-Blinded, Placebo-Controlled Trial. Front Pharmacol. 2019 Nov 22;10:1382. doi: 10.3389/fphar.2019.01382. eCollection 2019.
    Results Reference
    derived

    Learn more about this trial

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

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