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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:
ClinicalTrials.gov Identifier:
NCT01439945
First Posted: September 23, 2011
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
Results First Submitted: December 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Cancer Survivor
Hot Flashes
Interventions: Drug: magnesium oxide
Other: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After the double blind phase patient were allowed to re-registered on the Optional Continuation Phase of the study. This phase lasted up to 4 weeks of treatment following either 800 or 1200 mg/day treatment group.

Reporting Groups
  Description
Low Dose Magnesium Oxide (800 mg/Day)

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

High Dose Magnesium Oxide (1200 mg/Day)

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Low Dose Placebo

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take two placebo tablets daily (QD).

High Dose Placebo

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take three placebo tablets daily (QD).


Participant Flow for 2 periods

Period 1:   Double-Blind Treatment Phase
    Low Dose Magnesium Oxide (800 mg/Day)   High Dose Magnesium Oxide (1200 mg/Day)   Low Dose Placebo   High Dose Placebo
STARTED   97   96   48   48 
COMPLETED   93   91   45   46 
NOT COMPLETED   4   5   3   2 
Withdrawal by Subject                3                3                3                1 
Ineligible                1                2                0                1 

Period 2:   Optional Continuation Phase
    Low Dose Magnesium Oxide (800 mg/Day)   High Dose Magnesium Oxide (1200 mg/Day)   Low Dose Placebo   High Dose Placebo
STARTED   72   44   0   0 
COMPLETED   72   44   0   0 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Low Dose Magnesium Oxide (800 mg/Day)

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

High Dose Magnesium Oxide (1200 mg/Day)

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Placebo

Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take two or three placebo tablets daily (QD).

Total Total of all reporting groups

Baseline Measures
   Low Dose Magnesium Oxide (800 mg/Day)   High Dose Magnesium Oxide (1200 mg/Day)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 93   91   91   275 
Age, Customized 
[Units: Participants]
Count of Participants
       
Age Group         
18-49 years      15  16.1%      15  16.5%      15  16.5%      45  16.4% 
>=50      78  83.9%      76  83.5%      76  83.5%      230  83.6% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      93 100.0%      91 100.0%      91 100.0%      275 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   93   91   91   275 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period.   [ Time Frame: Baseline to Week 8 ]

2.  Secondary:   Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period   [ Time Frame: Baseline to Week 8 ]

3.  Secondary:   Frequency and Maximum Grade of Adverse Events Reported Via the CTCAE 4.0 During the Treatment Period.   [ Time Frame: Baseline to Week 8 ]

4.  Secondary:   The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination   [ Time Frame: Baseline to week 8 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Charles Lawrence Loprinzi, M.D.
Organization: Mayo Clinic
e-mail: cloprinzi@mayo.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01439945     History of Changes
Other Study ID Numbers: NCCTG-N10C2
CDR0000711021 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-03537 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: September 22, 2011
First Posted: September 23, 2011
Results First Submitted: December 8, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017