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


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

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Trial Information

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


OBJECTIVES:

Primary

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

Secondary

- 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


DISEASE CHARACTERISTICS:

- 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
eligible)

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- 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:

Interventional

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:

No

Principal Investigator

Thomas J. Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

MCC-12062

NCT ID:

NCT01008904

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

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