Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Alliance for Clinical Trials in Oncology
With
OBJECTIVES: Primary * Evaluate the efficacy of magnesium oxide on hot flashes in women with a history of breast cancer. Secondary * Evaluate the side-effect profile of magnesium oxide in this study population. * Evaluate the effect of magnesium oxide on the secondary outcomes hot flash frequencies, hot flash severities, toxicities (including diarrhea), and hot flash-related daily interference on activities. * Evaluate the effect of magnesium oxide on the change of magnesium level (for the first 150 patients). OUTLINE: This is a multicenter study. Patients are stratified according to age (18-49 years vs ≥ 50 years), current tamoxifen and/or selective estrogen receptor modulator (yes vs no), current aromatase inhibitor (yes vs no), and daily frequency of hot flashes (4-9 vs ≥ 10). Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive a low-dose of magnesium oxide orally (PO) daily (QD). * Arm II: Patients receive a high-dose of magnesium oxide PO QD. * Arm III: Patients receive a low-dose of placebo PO QD. * Arm IV: Patients receive a high-dose of placebo PO QD. In all arms, treatment continues for 8 weeks in the absence of unacceptable toxicity. Some patients may continue or crossover to receive magnesium for 4 more weeks. Patients complete the Hot Flash Diary daily for 9 weeks beginning 1 week before treatment. They also complete the Symptom Experience Questionnaire, the Profile of Mood States (POMS), and Hot Flash-Related Daily Interference Scale (HFRDIS) questionnaires periodically during study treatment. Patients undergo blood sample collection at baseline and at the end of weeks 5 and 9 for serum magnesium level analysis.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
