NCT01439945

Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer

A Randomized, Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Magnesium oxide may help relieve hot flashes symptoms in women with a history of breast cancer. PURPOSE: This randomized clinical trial studies how well a high-dose or a low-dose of magnesium oxide works compared to placebo in treating menopausal women with hot flashes and a history of breast cancer.

Detailed description

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.

Conditions

• Breast Cancer
• Cancer Survivor
• Hot Flashes

Interventions

Type	Name	Description
DRUG	magnesium oxide	Given PO
OTHER	placebo	Given PO

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-09-23
• Last updated: 2017-04-04
• Results posted: 2017-04-04

Locations

283 sites across 1 country: United States