Depression Clinical Trial
Official title:
Melatonin as a Circadian Clock Regulator, Neuromodulator and Myelo-protector in Adjuvant Breast Cancer Chemotherapy: a Randomized, Double-blind, Placebo-controlled Trial.
Verified date | January 2017 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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