Patients receive a low-dose of magnesium oxide orally (PO) daily (QD).

Patients receive a high-dose of magnesium oxide PO QD.

Patients receive a low-dose of placebo PO QD.

Patients receive a high-dose of placebo PO QD.

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).

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

High Dose Magnesium Oxide (1200 mg/Day)

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).

Placebo

Total

Age, Customized

Sex: Female, Male

Region of Enrollment

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.

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.

Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period

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.

Frequency and Maximum Grade of Adverse Events Reported Via the CTCAE 4.0 During the Treatment Period.

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 Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination

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 Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS) From Baseline to Treatment Termination.

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 Intra-patient Changes of Magnesium Level From Baseline to the End of Treatment Period Between Magnesium Oxide and Placebo Arms.

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).

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 three placebo tablets daily (QD).

High Dose Placebo

Double-Blind Treatment Phase

Optional Continuation Phase

Charles Lawrence Loprinzi, M.D.

After the double blind phase patient questionnaire booklet has been completed and returned to the investigator, the patient will be told whether she was on magnesium or placebo. If the patient wishes to continue or start the magnesium, and healthcare provider approves that this is an appropriate option, she may be registered on the Optional Continuation Phase of the study. This phase will last up to 4 weeks of treatment following either 800 or 1200 mg/day treatment group.

Breast Cancer

Cancer Survivor

Hot Flashes

magnesium oxide

placebo

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Mayo Clinic Scottsdale

Aurora Presbyterian Hospital

Boulder Community Hospital

Penrose Cancer Center at Penrose Hospital

St. Anthony Central Hospital

Porter Adventist Hospital

Presbyterian - St. Luke's Medical Center

St. Joseph Hospital

Rose Medical Center

Swedish Medical Center

Poudre Valley Hospital

Front Range Cancer Specialists

North Colorado Medical Center

Sky Ridge Medical Center

Hope Cancer Care Center at Longmont United Hospital

McKee Medical Center

St. Mary - Corwin Regional Medical Center

Exempla Lutheran Medical Center

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Herbert D. Kerman Regional Oncology Center - Daytona Beach

Mayo Clinic - Jacksonville

MBCCOP - Medical College of Georgia Cancer Center

Kapiolani Medical Center at Pali Momi

Oncare Hawaii, Incorporated - Pali Momi

Cancer Research Center of Hawaii

OnCare Hawaii, Incorporated - Lusitana

Queen's Cancer Institute at Queen's Medical Center

Straub Clinic and Hospital, Incorporated

Kuakini Medical Center

OnCare Hawaii, Incorporated - Kuakini

Kapiolani Medical Center for Women and Children

Tripler Army Medical Center

Castle Medical Center

Kauai Medical Clinic

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Rush-Copley Cancer Care Center

Illinois CancerCare - Bloomington

St. Joseph Medical Center

Illinois CancerCare - Canton

Illinois CancerCare - Carthage

Eureka Community Hospital

Illinois CancerCare - Eureka

Galesburg Clinic, PC

Illinois CancerCare - Havana

Illinois CancerCare - Kewanee Clinic

Illinois CancerCare - Macomb

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

Illinois CancerCare - Monmouth

OSF Holy Family Medical Center

BroMenn Regional Medical Center

Community Cancer Center

Community Hospital of Ottawa

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Cancer Treatment Center at Pekin Hospital

Illinois CancerCare - Pekin

Proctor Hospital

CCOP - Illinois Oncology Research Association

Oncology Hematology Associates of Central Illinois, PC - Peoria

Methodist Medical Center of Illinois

OSF St. Francis Medical Center

Illinois CancerCare - Peru

Illinois Valley Community Hospital

Illinois CancerCare - Princeton

CCOP - Carle Cancer Center

Elkhart Clinic, LLC

Michiana Hematology-Oncology, PC - Elkhart

Elkhart General Hospital

St. Francis Hospital Cancer Care Services

Howard Community Hospital

Center for Cancer Therapy at LaPorte Hospital and Health Services

Saint Anthony Memorial Health Centers

Michiana Hematology-Oncology, PC - South Bend

Saint Joseph Regional Medical Center

Michiana Hematology Oncology PC - Plymouth

Reid Hospital & Health Care Services

CCOP - Northern Indiana CR Consortium

Memorial Hospital of South Bend

Michiana Hematology Oncology PC - La Porte

Cedar Rapids Oncology Associates

Mercy Regional Cancer Center at Mercy Medical Center

Medical Oncology and Hematology Associates - West Des Moines

Mercy Cancer Center - West Lakes

CCOP - Iowa Oncology Research Association

John Stoddard Cancer Center at Iowa Methodist Medical Center

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Medical Oncology and Hematology Associates at Mercy Cancer Center

Mercy Cancer Center at Mercy Medical Center - Des Moines

John Stoddard Cancer Center at Iowa Lutheran Hospital

Mercy Cancer Center at Mercy Medical Center - North Iowa

McCreery Cancer Center at Ottumwa Regional

Siouxland Hematology-Oncology Associates, LLP

Mercy Medical Center - Sioux City

St. Luke's Regional Medical Center

Methodist West Hospital

Cancer Center of Kansas, PA - Chanute

Cancer Center of Kansas, PA - Dodge City

Cancer Center of Kansas, PA - El Dorado

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

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

cancro da mama

breast neoplasms

mgo/cancro da mama

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

O mais completo banco de dados de ervas medicinais apoiado pela ciência