Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01008904
First received: November 5, 2009
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Cancer Survivor
Hot Flashes
Unspecified Adult Solid Tumor, Protocol Specific
Drug: magnesium oxide
Other: questionnaire administration
Procedure: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Phase II Trial of Magnesium Supplements to Reduce Menopausal Hot Flashes in Cancer Patients

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5) [ Time Frame: from baseline to week 5 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Difference in Quality of Life [ Time Frame: from baseline to week 5 ] [ Designated as safety issue: No ]
    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.


Enrollment: 31
Study Start Date: July 2009
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (magnesium oxide)
Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
Drug: magnesium oxide
Given PO
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008904

Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Thomas J. Smith, MD Massey Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01008904     History of Changes
Other Study ID Numbers: MCC-12062, HM12062, CDR0000650938, NCI-2012-01059
Study First Received: November 5, 2009
Results First Received: August 12, 2013
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
cancer survivor
hot flashes
breast cancer
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Magnesium Oxide
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014