Breast Cancer, Cancer Survivor, Hot Flashes, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
cancer survivor, hot flashes, breast cancer, unspecified adult solid tumor, protocol specific
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.
Detailed description
OBJECTIVES: Primary * To determine if magnesium oxide supplement will decrease the frequency and severity of hot flashes by 50% in menopausal women with cancer. Secondary * To evaluate the effect of magnesium oxide on overall quality of life. * To evaluate the toxicities of magnesium oxide when administered at commonly used supplement doses. OUTLINE: Patients receive oral magnesium oxide once daily in weeks 2-5. Patients whose hot flashes are not satisfactorily controlled after 2 weeks of treatment may receive magnesium oxide twice daily in weeks 4 and 5. Patients complete a daily hot flash diary for 5 weeks beginning 1 week before treatment. Patients also complete quality-of-life, symptom, and self-assessment questionnaires at baseline, once weekly during treatment, and at the completion of treatment. After completion of study treatment, patients are followed up for at least 30 days.
Interventions
DRUGmagnesium oxide
Given PO
OTHERquestionnaire administration
Ancillary studies
PROCEDUREquality-of-life assessment
Ancillary studies
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5) | from baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Quality of Life | from baseline to week 5 | 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. |
Participant flow
Recruitment details
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.
Pre-assignment details
Of the 31 patients enrolled, 29 received treatment. 25 completed treatment and were analyzed.
Participants by arm
| Arm | Count |
|---|---|
| Supportive Care (Magnesium Oxide) Patients receive magnesium oxide PO QD or BID for 4 weeks. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | unexpected unrelated surgery | 1 |
Baseline characteristics
| Characteristic | Supportive Care (Magnesium Oxide) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 53.5 years STANDARD_DEVIATION 3.7 |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 29 |
| serious Total, serious adverse events | 1 / 29 |
Outcome results
Primary
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.
Time frame: from baseline to week 5
Population: 25 patients completed the complete study and were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care (Magnesium Oxide) | 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
Difference in Quality of Life
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.
Time frame: from baseline to week 5
Population: Participants who completed treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care (Magnesium Oxide) | Difference in Quality of Life | 0.14 units on a scale | Standard Error 0.3 |