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
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
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
NCT ID
NCT03205033
First Posted
June 28, 2017
Last Updated
June 28, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
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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