Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
RATIONALE: Magnesium oxide may help relieve hot flashes symptoms in women with a history of breast cancer.
PURPOSE: This randomized clinical trial studies how well a high-dose or a low-dose of magnesium oxide works compared to placebo in treating menopausal women with hot flashes and a history of breast cancer.
|Breast Cancer Cancer Survivor Hot Flashes||Drug: magnesium oxide Other: placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Supportive Care
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes|
- The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period. [ Time Frame: Baseline to Week 8 ]
The primary endpoint is the intra-patient changes of weekly hot flash activity from baseline during the treatment period. The hot flash activity will be measured by the weekly average hot flash score, which is a composite entity of both frequency and severity of hot flashes.
The hot flash severity is graded from 1 to 4 (1=mild, 2=moderate, 3=severe, and 4=very severe). The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The weekly hot flash score was calculated by adding all scores for the week.
The mean Hot Flash Score for each week for each group is reported and a repeated measures analysis is reported comparing each dose level group to the Placebo group.
- Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period [ Time Frame: Baseline to Week 8 ]As part of the Hot Flash Diary, the number of hot flashes was recorded for each patient for each week. For this endpoint, the mean number of hot flashes for each group is reported. A repeated measure analysis comparing each dose level group and the Placebo is reported.
- Frequency and Maximum Grade of Adverse Events Reported Via the CTCAE 4.0 During the Treatment Period. [ Time Frame: Baseline to Week 8 ]Frequency and severity of adverse events reported by patients in weekly Symptom Experience Questionnaire and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
- The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination [ Time Frame: Baseline to week 8 ]We will use the Symptom Experience Questionnaire (SEQ) to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. The questionnaire is 14 questions and is based on a 0="Not at all" to 10="As bad as it can be" scale. The change of severity of symptoms as measured by the SEQ from baseline to treatment termination will be first summarized by descriptive statistics as a percent change from baseline.
- The Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS) From Baseline to Treatment Termination. [ Time Frame: Baseline to week 8 ]We will use the Hot Flash Related Daily Interference Scale (HFRDIS) (SEQ) to evaluate the specific effect of hot flashes have on various life activities such as work, social, leisure and relationships while receiving treatment. The questionnaire is 10 questions and is based on a 0="Do not interfere" to 10="Completely interfere" scale. The weekly score is the summation of these 10 questions and therefore ranges from 0 to 100. The total change in severity of symptoms is calculated by subtracting the week 8 score from the baseline. Therefore, values below zero indicate a worsening of symptoms and values above zero indicate an improvement and has a maximum range of -100 to 100. A gatekeeper procedure, following a fixed-sequence hypothesis testing method, was used to examine the higher dose of magnesium vs. placebo first and then the lower dose of magnesium vs. placebo, if the former was statistically significant.
- The Intra-patient Changes of Magnesium Level From Baseline to the End of Treatment Period Between Magnesium Oxide and Placebo Arms. [ Time Frame: Baseline to week 8 ]
The intra-patient changes of magnesium level from baseline to the end of treatment period between magnesium oxide and placebo arms will be compared using a repeated measures model.
Serum magnesium concentrations will be performed prior to study medication usage and during the last week of blinded study use. These will be obtained in the first 150 patients. Mean change in serum magnesium concentrations will be compared between the 3 study arms to determine whether there are any apparent changes in the patients receiving placebos vs the two magnesium doses.
|Study Start Date:||September 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive a low-dose of magnesium oxide orally (PO) daily (QD).
Drug: magnesium oxide
Experimental: Arm II
Patients receive a high-dose of magnesium oxide PO QD.
Drug: magnesium oxide
Placebo Comparator: Arm III
Patients receive a low-dose of placebo PO QD.
Placebo Comparator: Arm IV
Patients receive a high-dose of placebo PO QD.
- Evaluate the efficacy of magnesium oxide on hot flashes in women with a history of breast cancer.
- Evaluate the side-effect profile of magnesium oxide in this study population.
- Evaluate the effect of magnesium oxide on the secondary outcomes hot flash frequencies, hot flash severities, toxicities (including diarrhea), and hot flash-related daily interference on activities.
- Evaluate the effect of magnesium oxide on the change of magnesium level (for the first 150 patients).
OUTLINE: This is a multicenter study. Patients are stratified according to age (18-49 years vs ≥ 50 years), current tamoxifen and/or selective estrogen receptor modulator (yes vs no), current aromatase inhibitor (yes vs no), and daily frequency of hot flashes (4-9 vs ≥ 10). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive a low-dose of magnesium oxide orally (PO) daily (QD).
- Arm II: Patients receive a high-dose of magnesium oxide PO QD.
- Arm III: Patients receive a low-dose of placebo PO QD.
- Arm IV: Patients receive a high-dose of placebo PO QD. In all arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.
Some patients may continue or crossover to receive magnesium for 4 more weeks.
Patients complete the Hot Flash Diary daily for 9 weeks beginning 1 week before treatment. They also complete the Symptom Experience Questionnaire, the Profile of Mood States (POMS), and Hot Flash-Related Daily Interference Scale (HFRDIS) questionnaires periodically during study treatment.
Patients undergo blood sample collection at baseline and at the end of weeks 5 and 9 for serum magnesium level analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439945
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|Principal Investigator:||Charles L. Loprinzi, MD||Mayo Clinic|