Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008904
• Other study ID #: MCC-12062
• Secondary ID: HM12062CDR000065
• Status: Completed
• Phase: Phase 2
• First received: November 5, 2009
• Last updated: June 17, 2016
• Start date: July 2009
• Est. completion date: March 2013

Study information

• Verified date: June 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Magnesium oxide may help relieve hot flashes in women with cancer.

PURPOSE: This phase II trial is studying how well magnesium oxide works in treating hot flashes in menopausal women with cancer.

Description:

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

• Eastern Cooperative Oncology Group (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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Cancer Survivor
• Hot Flashes
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• magnesium oxide
Given PO

Other:
• questionnaire administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

References & Publications (1)

Park H, Parker GL, Boardman CH, Morris MM, Smith TJ. A pilot phase II trial of magnesium supplements to reduce menopausal hot flashes in breast cancer patients. Support Care Cancer. 2011 Jun;19(6):859-63. doi: 10.1007/s00520-011-1099-7. Epub 2011 Jan 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)	Hot flash score (frequency x severity) at baseline was compared to the end of treatment. The number of flashes in a 24 hour day and a score combining the number and severity of hot flashes (ie, 1 point for mild, 2 points for moderate, 3 points for severe and 4 points for very severe.	from baseline to week 5	No
Secondary	Difference in Quality of Life	Mayo Clinic Uniscale instrument (6 questions with each question rating 0=as bad as it can be and 10=as good as it can be). A lower score is considered to be a better outcome.	from baseline to week 5	No