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| ID | Type | Description | Link |
|---|---|---|---|
| HM12062 | Other Identifier | VCU IRB | |
| CDR0000650938 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-2012-01059 | Registry Identifier | CTRP (Clinical Trials Reporting System) |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (magnesium oxide) | Experimental | Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnesium oxide | Drug | Given PO |
| |
| questionnaire administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J. Smith, MD | Massey Cancer Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21271347 | Result | 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. |
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Of the 31 patients enrolled, 29 received treatment. 25 completed treatment and were analyzed.
We enrolled female patients with bothersome hot flashes (defined by their occurrence ≥14 times per week and of sufficient severity to make the patient desire therapeutic intervention for ≥ 1 month prior to study entry) after undergoing treatment for cancer. Patients were recruited from the Massey Cancer Center oncology clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Supportive Care (Magnesium Oxide) | Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
patient who started study treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Supportive Care (Magnesium Oxide) | Patients receive magnesium oxide PO QD or BID for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 25 patients completed the complete study and were analyzed | Posted | Mean | Standard Error | percentage of difference | from baseline to week 5 |
|
|
Study start to study completion. (5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supportive Care (Magnesium Oxide) | Patients receive magnesium oxide PO QD or BID for 4 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgery | Skin and subcutaneous tissue disorders | CTC V3 | Non-systematic Assessment | unrelated due to seroma involving the left breast flap, after bilateral TRAM flap |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTC V3 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas J. Smith, MD | Virginia Commonwealth University | 410-955-2091 | tsmit136@jhmi.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008277 | Magnesium Oxide |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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| Other |
Ancillary studies |
|
| quality-of-life assessment | Procedure | Ancillary studies |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 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. | Participants who completed treatment | Posted | Mean | Standard Error | units on a scale | from baseline to week 5 |
|
|
|
| 1 |
| 29 |
| 2 |
| 29 |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |