Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

NCT01008904 | Completed Phase 2 Results DMC

• 4 other identifiers: MCC-12062HM12062CDR0000650938NCI-2012-01059
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer; Cancer Survivor; Hot Flashes; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

cancer survivor; hot flashes; breast cancer; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Difference in Quality of Life

  from baseline to week 5

Study Arms (1)

Supportive care (magnesium oxide)

EXPERIMENTAL

Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.

Drug: magnesium oxide; Other: questionnaire administration; Procedure: quality-of-life assessment

Interventions

magnesium oxide DRUG

Given PO

Supportive care (magnesium oxide)

questionnaire administration OTHER

Ancillary studies

Supportive care (magnesium oxide)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Supportive care (magnesium oxide)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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: * Eastern Cooperative Oncology Group (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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Related Publications (1)

• 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.

  PMID: 21271347 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes

Interventions

Magnesium Oxide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Thomas J. Smith, MD
• Organization: Virginia Commonwealth University

tsmit136@jhmi.edu

410-955-2091

Study Officials

• Thomas J. Smith, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 21, 2016
• Results First Posted: February 5, 2014

Record last verified: 2016-06