Trial Outcomes & Findings for Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer (NCT NCT01008904)

NCT ID: NCT01008904

Last Updated: 2016-06-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: from baseline to week 5
• Results posted on: 2016-06-21

Participant Flow

We enrolled female patients with bothersome hot flashes (defined by their occurrence ≥14 times per week and of sufficient severity to make the patient desire therapeutic intervention for ≥ 1 month prior to study entry) after undergoing treatment for cancer. Patients were recruited from the Massey Cancer Center oncology clinics.

Of the 31 patients enrolled, 29 received treatment. 25 completed treatment and were analyzed.

Participant milestones

Measure	Supportive Care (Magnesium Oxide) Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
Overall Study STARTED	29
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Supportive Care (Magnesium Oxide) Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
Overall Study Lost to Follow-up	1
Overall Study Adverse Event	2
Overall Study unexpected unrelated surgery	1

Baseline Characteristics

Magnesium Oxide in Treating Hot Flashes in Menopausal Women With Cancer

Baseline characteristics by cohort

Measure	Supportive Care (Magnesium Oxide) n=29 Participants Patients receive magnesium oxide PO QD or BID for 4 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	53.5 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: from baseline to week 5

Population: 25 patients completed the complete study and were analyzed

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.

Outcome measures

Measure	Supportive Care (Magnesium Oxide) n=25 Participants Patients receive magnesium oxide PO QD or BID for 4 weeks.
Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)	-50.4 percentage of difference Standard Error 40.9

SECONDARY outcome

Timeframe: from baseline to week 5

Population: Participants who completed treatment

Mayo Clinic Uniscale instrument (6 questions with each question rating 0=as bad as it can be and 10=as good as it can be). A lower score is considered to be a better outcome.

Outcome measures

Measure	Supportive Care (Magnesium Oxide) n=25 Participants Patients receive magnesium oxide PO QD or BID for 4 weeks.
Difference in Quality of Life	0.14 units on a scale Standard Error 0.3

Adverse Events

Supportive Care (Magnesium Oxide)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Supportive Care (Magnesium Oxide) n=29 participants at risk Patients receive magnesium oxide PO QD or BID for 4 weeks.
Skin and subcutaneous tissue disorders Surgery	3.4% 1/29 • Number of events 1 • Study start to study completion. (5 weeks

Other adverse events

Measure	Supportive Care (Magnesium Oxide) n=29 participants at risk Patients receive magnesium oxide PO QD or BID for 4 weeks.
Gastrointestinal disorders Diarrhea	6.9% 2/29 • Number of events 2 • Study start to study completion. (5 weeks

Additional Information

Thomas J. Smith, MD

Virginia Commonwealth University

Phone: 410-955-2091

Email: tsmit136@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place