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Trial record 1 of 1 for:    N10C2
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Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01439945
First received: September 22, 2011
Last updated: February 17, 2017
Last verified: February 2017

September 22, 2011
February 17, 2017
September 2011
August 2013   (Final data collection date for primary outcome measure)
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.

The intra-patient changes of weekly hot flash activity from baseline during the treatment period
Complete list of historical versions of study NCT01439945 on ClinicalTrials.gov Archive Site
  • 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.

  • The change of weekly frequency and maximum grade of hot flashes as measured by the Hot Flash Diary during the treatment period
  • The change of frequency and maximum grade of adverse events reported via the CTCAE 4.0 during the treatment period, in particular, diarrhea
  • The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination
  • The change of mood as measured by the POMS from baseline to treatment termination
  • The change of daily interference as measured by the HFRDIS from baseline to treatment termination
  • The intra-patient changes of weekly hot flash activity from baseline during the treatment period between two placebo groups using different dosing
  • The intra-patient changes of magnesium level from baseline to the end of treatment period between magnesium oxide and placebo arms and whether it is correlated with hot flash activity level and change
Not Provided
Not Provided
 
Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer
A Randomized, Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes

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.

OBJECTIVES:

Primary

  • Evaluate the efficacy of magnesium oxide on hot flashes in women with a history of breast cancer.

Secondary

  • 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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Supportive Care
  • Breast Cancer
  • Cancer Survivor
  • Hot Flashes
  • Drug: magnesium oxide
    Given PO
  • Other: placebo
    Given PO
  • Experimental: Arm I
    Patients receive a low-dose of magnesium oxide orally (PO) daily (QD).
    Intervention: Drug: magnesium oxide
  • Experimental: Arm II
    Patients receive a high-dose of magnesium oxide PO QD.
    Intervention: Drug: magnesium oxide
  • Placebo Comparator: Arm III
    Patients receive a low-dose of placebo PO QD.
    Intervention: Other: placebo
  • Placebo Comparator: Arm IV
    Patients receive a high-dose of placebo PO QD.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
289
August 2013
August 2013   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Women with a history of breast cancer (currently without malignant disease)
  • Bothersome hot flashes (defined by their occurrence ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention)
  • Presence of hot flashes for ≥ 30 days prior to study registration
  • Willingness to provide the biologic specimens as required by the protocol
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Women who are postmenopausal as defined by absence of a period in the past 12 months or bilateral oophorectomy

    • Women with at least one ovary but without a uterus should be deemed postmenopausal by either age over 55 or a combination of estrogen within a postmenopausal range (per local lab) and FSH over 40 mIU/mL
    • No women of childbearing potential or who are premenopausal
  • Creatinine clearance > 30 mL/min
  • Ability to complete questionnaire(s) by themselves or with assistance
  • ECOG performance status 0 or 1
  • No history of allergic or other adverse reaction to magnesium
  • No diabetes
  • No patients with conditions that are implicated in decreased absorption of magnesium (e.g., Crohn disease, ETOH abuse)
  • No patients who have diarrhea where magnesium might make it worse (per provider discretion)

PRIOR CONCURRENT THERAPY:

  • None of the following current (≤ 28 days prior to registration) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for ≥ 28 days and must not be expected to stop the medication during the study period):

    • Antineoplastic chemotherapy (trastuzumab or lapatinib are allowed)
    • Androgens
    • Estrogens (any delivery route)
    • Progestational agents
  • No prior use of magnesium for hot flashes
  • No current or planned use of gabapentin (for any reasons) or antidepressants (for any reasons) or other agents for treating hot flashes (except stable dose of vitamin E is allowed as long as it was started > 30 days prior to study registration and are to be continued through the study period; soy is allowed, if it is planned to be continued at the same dose during the study period)
  • No current use of magnesium for any indication (except one standard multiple vitamin dose is allowed per day)
  • Not taking diuretics, corticosteroids, bile acid sequestrants, and other prescription and over-the-counter medications that may affect magnesium levels
  • No current (≤ 7 days prior to registration) or planned use of other non-drug therapies for managing hot flashes, such as acupuncture or yoga (use of these therapies for other reasons is allowed)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01439945
NCCTG-N10C2
NCCTG-N10C2
CDR0000711021 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-03537 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
Yes
Not Provided
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Principal Investigator: Charles L. Loprinzi, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP