Breast Cancer Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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