Clinical trial · Interventional
Melatonin as a Circadian Clock Regulator, Neuromodulator and Myelo-protector in Adjuvant Breast Cancer Chemotherapy
Melatonin as a Circadian Clock Regulator, Neuromodulator and Myelo-protector in Adjuvant Breast Cancer Chemotherapy: a Randomized, Double-blind, Placebo-controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression | — | UNRESOLVED | — |
| Genotoxicity | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Sleep Disorders, Circadian Rhythm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melatonin 20 MG Oral Capsule | Drug | — | UNRESOLVED |
| Placebo oral capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Melatonin
- description
- Melatonin 20 mg Oral Capsules, once a day at bedtime
- interventionNames
- Drug: Melatonin 20 MG Oral Capsule
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo Oral Capsules, once a day at bedtime
- interventionNames
- Drug: Placebo oral capsule
Primary outcomes (1)
- measure
- To evaluate the response to melatonin as a sleep-wake rhythm synchronizer on the effects induced by chemotherapy in women with breast cancer.
- timeFrame
- 1 capsule of melatonin 20 mg or Placebo capsule, once a day, 1 hour before go to bed
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPalmer 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 31824318