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Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT01439945
First received: September 22, 2011
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Cancer Survivor
Hot Flashes
Drug: magnesium oxide
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Magnesium Supplements to Reduce Menopausal Hot Flashes

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • The intra-patient changes of weekly hot flash activity from baseline during the treatment period [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change of weekly frequency and maximum grade of hot flashes as measured by the Hot Flash Diary during the treatment period [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • The change of frequency and maximum grade of adverse events reported via the CTCAE 4.0 during the treatment period, in particular, diarrhea [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: Yes ]
  • The change of severity of symptoms as measured the Symptom Experience Questionnaire from baseline to treatment termination [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • The change of mood as measured by the POMS from baseline to treatment termination [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • The change of daily interference as measured by the HFRDIS from baseline to treatment termination [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • The intra-patient changes of weekly hot flash activity from baseline during the treatment period between two placebo groups using different dosing [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: September 2011
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive a low-dose of magnesium oxide orally (PO) daily (QD).
Drug: magnesium oxide
Given PO
Experimental: Arm II
Patients receive a high-dose of magnesium oxide PO QD.
Drug: magnesium oxide
Given PO
Placebo Comparator: Arm III
Patients receive a low-dose of placebo PO QD.
Other: placebo
Given PO
Placebo Comparator: Arm IV
Patients receive a high-dose of placebo PO QD.
Other: placebo
Given PO

Detailed Description:

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.

  Eligibility

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

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)
  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: NCT01439945

  Show 283 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Charles L. Loprinzi, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier: NCT01439945     History of Changes
Other Study ID Numbers: N10C2, NCCTG-N10C2, CDR0000711021, NCI-2011-03537
Study First Received: September 22, 2011
Last Updated: July 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
hot flashes
cancer survivor
breast cancer

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 August 25, 2014