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Magnesium Oxide in Treating P...

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

Last Updated: 2017-04-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer Cancer Survivor Hot Flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I

Patients receive a low-dose of magnesium oxide orally (PO) daily (QD).

Group Type EXPERIMENTAL

magnesium oxide

Intervention Type DRUG

Given PO

Arm II

Patients receive a high-dose of magnesium oxide PO QD.

Group Type EXPERIMENTAL

magnesium oxide

Intervention Type DRUG

Given PO

Arm III

Patients receive a low-dose of placebo PO QD.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given PO

Arm IV

Patients receive a high-dose of placebo PO QD.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given PO

Interventions

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magnesium oxide

Given PO

Intervention Type DRUG

placebo

Given PO

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Women with a history of breast cancer (currently without malignant disease)
* Bothersome hot flashes (defined by their occurrence ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention)
* Presence of hot flashes for ≥ 30 days prior to study registration
* Willingness to provide the biologic specimens as required by the protocol
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Women who are postmenopausal as defined by absence of a period in the past 12 months or bilateral oophorectomy

* Women with at least one ovary but without a uterus should be deemed postmenopausal by either age over 55 or a combination of estrogen within a postmenopausal range (per local lab) and FSH over 40 mIU/mL
* No women of childbearing potential or who are premenopausal
* Creatinine clearance \> 30 mL/min
* Ability to complete questionnaire(s) by themselves or with assistance
* ECOG performance status 0 or 1
* No history of allergic or other adverse reaction to magnesium
* No diabetes
* No patients with conditions that are implicated in decreased absorption of magnesium (e.g., Crohn disease, ETOH abuse)
* No patients who have diarrhea where magnesium might make it worse (per provider discretion)

PRIOR CONCURRENT THERAPY:

* None of the following current (≤ 28 days prior to registration) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for ≥ 28 days and must not be expected to stop the medication during the study period):

* Antineoplastic chemotherapy (trastuzumab or lapatinib are allowed)
* Androgens
* Estrogens (any delivery route)
* Progestational agents
* No prior use of magnesium for hot flashes
* No current or planned use of gabapentin (for any reasons) or antidepressants (for any reasons) or other agents for treating hot flashes (except stable dose of vitamin E is allowed as long as it was started \> 30 days prior to study registration and are to be continued through the study period; soy is allowed, if it is planned to be continued at the same dose during the study period)
* No current use of magnesium for any indication (except one standard multiple vitamin dose is allowed per day)
* Not taking diuretics, corticosteroids, bile acid sequestrants, and other prescription and over-the-counter medications that may affect magnesium levels
* No current (≤ 7 days prior to registration) or planned use of other non-drug therapies for managing hot flashes, such as acupuncture or yoga (use of these therapies for other reasons is allowed)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles L. Loprinzi, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Hematology Oncology Center

Elyria, Ohio, United States

Site Status

Blanchard Valley Medical Associates

Findlay, Ohio, United States

Site Status

Middletown Regional Hospital

Franklin, Ohio, United States

Site Status

Wayne Hospital

Greenville, Ohio, United States

Site Status

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Herbert D. Kerman Regional Oncology Center - Daytona Beach

Daytona Beach, Florida, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status