Conditions: Breast Cancer Cancer Survivor Hot Flashes
Keywords: hot flashes cancer survivor breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 289
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Patients receive a low-dose of magnesium oxide orally (PO) daily (QD). arm 2: Patients receive a high-dose of magnesium oxide PO QD. arm 3: Patients receive a low-dose of placebo PO QD. arm 4: Patients receive a high-dose of placebo PO QD.

Interventions: intervention 1: magnesium oxide intervention 2: placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol document: