Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Virginia Commonwealth University
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01008904
First received: November 5, 2009
Last updated: April 23, 2013
Last verified: April 2013
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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:
- Difference in hot flash activity (score) between baseline and week 5 [ Time Frame: from baseline to week 5 ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Difference in quality of life [ Time Frame: from baseline to week 5 ] [ Designated as safety issue: No ]Difference in quality of life measured using Linear Analogue Self-Assessment (LASA) Quality of Life Questionnaire
- Toxicity and adverse events [ Time Frame: up to 30 days post treatment ] [ Designated as safety issue: Yes ]Toxicity and adverse events categorized according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. We will analyze the toxicities in a descriptive manner.
- Difference in self-assessment scale score [ Time Frame: from baseline to week 5 ] [ Designated as safety issue: No ]We will analyze the self-reported side effects in a descriptive manner.
| Enrollment: | 31 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | February 2014 |
| 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 PO QD or BID 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 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.
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:
- 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 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 |
| Last Updated: | April 23, 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 May 23, 2013