Melatonin as a Circadian Clock Regulator, Neuromodulator and Myelo-protector in Adjuvant Breast Cancer Chemotherapy
Słowa kluczowe
Abstrakcyjny
Opis
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.
Daktyle
| Ostatnia weryfikacja: | 12/31/2016 |
| Pierwsze przesłane: | 06/27/2017 |
| Szacowana liczba przesłanych rejestracji: | 06/27/2017 |
| Wysłany pierwszy: | 07/01/2017 |
| Ostatnia aktualizacja przesłana: | 06/27/2017 |
| Ostatnia opublikowana aktualizacja: | 07/01/2017 |
| Rzeczywista data rozpoczęcia badania: | 12/31/2015 |
| Szacowana data zakończenia podstawowej działalności: | 12/31/2016 |
| Szacowana data zakończenia badania: | 12/31/2016 |
Stan lub choroba
Interwencja / leczenie
Drug: Melatonin
Drug: Placebo
Faza
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| Active Comparator: Melatonin Melatonin 20 mg Oral Capsules, once a day at bedtime | Drug: Melatonin 1 capsule/day 1 hour before go to bed |
| Placebo Comparator: Placebo Placebo Oral Capsules, once a day at bedtime | Drug: Placebo 1 capsule/day 1 hour before go to bed |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
| Płeć kwalifikująca się do nauki | Female |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | 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 |
Wynik
Podstawowe miary wyników
1. To evaluate the response to melatonin as a sleep-wake rhythm synchronizer on the effects induced by chemotherapy in women with breast cancer. [1 capsule of melatonin 20 mg or Placebo capsule, once a day, 1 hour before go to bed]
