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A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients

Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Cancer Survivor, Hot Flashes, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients



- To determine if magnesium oxide supplement will decrease the frequency and severity of
hot flashes by 50% in menopausal women with cancer.


- To evaluate the effect of magnesium oxide on overall quality of life.

- To evaluate the effect of magnesium oxide on other drugs used.

- To evaluate the toxicities of magnesium oxide when administered at commonly used
supplement doses.

OUTLINE: Patients receive oral magnesium oxide once daily in weeks 2-5. Patients whose hot
flashes are not satisfactorily controlled after 2 weeks of treatment may receive magnesium
oxide twice daily in weeks 4 and 5.

Patients complete a daily hot flash diary for 5 weeks beginning 1 week before treatment.
Patients also complete quality-of-life, symptom, and self-assessment questionnaires at
baseline, once weekly during treatment, and at the completion of treatment.

After completion of study treatment, patients are followed up for at least 30 days.

Inclusion Criteria


- Meets 1 of the following criteria:

- History of breast cancer (currently without malignant disease)

- No history of breast cancer but wishes to avoid estrogen due to a perceived
increased risk of breast cancer

- Must have bothersome hot flashes (defined by their occurrence of ≥ 14 times per week
and of sufficient severity to make the patient desire therapeutic intervention) for ≥
1 month before study entry

- Has undergone treatment for cancer (patients other than breast cancer survivors are


- ECOG performance status 0-2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Creatinine clearance ≥ 30 mL/min

- No hypersensitivity to magnesium oxide

- No medical or other condition(s) that, in the opinion of the
investigator/sub-investigator, may compromise the objectives of the study


- See Disease Characteristics

- More than 4 weeks since prior and no concurrent antineoplastic chemotherapy,
androgens, estrogens, progestational agents, or gabapentin

- More than 28 days since prior and no other concurrent investigational drugs

- Concurrent tamoxifen, raloxifene, or aromatase inhibitors allowed provided patient
has been on a constant dose for > 4 weeks AND is not expected to stop the medication
during the study period

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Difference in hot flash activity (score) between baseline and week 5

Outcome Description:

Plots will provided of hot flash scores over the 5 week period. Descriptive statistics for the hot flash measurements will be provided. A longitudinal repeated measures analysis using generalized linear models (GLM) methods will be applied to analyze the hot flash

Outcome Time Frame:

from baseline to week 5

Safety Issue:


Principal Investigator

Thomas J. Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2009

Completion Date:

February 2014

Related Keywords:

  • Breast Cancer
  • Cancer Survivor
  • Hot Flashes
  • Unspecified Adult Solid Tumor, Protocol Specific
  • cancer survivor
  • hot flashes
  • breast cancer
  • unspecified adult solid tumor, protocol specific
  • Breast Neoplasms
  • Hot Flashes