NCT03205033

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

June 28, 2017

Last Update Submit

June 28, 2017

Conditions

Sleep Disorders, Circadian RhythmDepressionGenotoxicityPain

Keywords

MelatoninBreast cancerChemotherapySleep-wake rhytmsCircadian rhythms

Outcome Measures

Primary Outcomes (1)

  • 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

    1 capsule of melatonin 20 mg or Placebo capsule, once a day, 1 hour before go to bed

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

Melatonin 20 mg Oral Capsules, once a day at bedtime

Drug: Melatonin 20 MG Oral Capsule

Placebo

PLACEBO COMPARATOR

Placebo Oral Capsules, once a day at bedtime

Drug: Placebo oral capsule

Interventions

Melatonin 20 MG Oral CapsuleDRUG

1 capsule/day 1 hour before go to bed

Also known as: MTN
Melatonin
Placebo oral capsuleDRUG

1 capsule/day 1 hour before go to bed

Also known as: PCB
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Diagnosed with breast cancer
  • Indicated for the adjuvant treatment for breast cancer
  • Between 18 years and 75 years
  • Alphabetized

You may not qualify if:

  • Pregnant
  • Epilepsy
  • Brain Stroke
  • Multiple sclerosis
  • BMI above 45 kg / m 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31824318DERIVED

MeSH Terms

Conditions

Sleep Disorders, Circadian RhythmDepressionPainBreast Neoplasms

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental DisordersBehavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Wolnei Caumo, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 2, 2017

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 2, 2017

Record last verified: 2017-01