Melatonin as a Circadian Clock Regulator, Neuromodulator and Myelo-protector in Adjuvant Breast Cancer Chemotherapy
Condition: Sleep Disorders, Circadian Rhythm; Depression; Genotoxicity; Pain
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Melatonin 20 MG Oral Capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule/day 1 hour before go to bed; 1 capsule/day 1 hour before go to bed
Other intervention name(s): MTN; PCB
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Melatonin; Breast cancer; Chemotherapy; Sleep-wake rhytms; Circadian rhythms