Breast Cancer, Hot Flashes
Conditions
Keywords
breast cancer, hot flashes
Brief summary
RATIONALE: Pregabalin may help relieve hot flashes in women with a history of breast cancer or those who have no history and do not wish to take estrogen therapy for fear of increased risk of breast cancer. It is not yet known what dose of pregabalin may be more effective in treating hot flashes. PURPOSE: This is a randomized phase III trial to determine the efficacy of two doses of pregabalin, in comparison to placebo, in the prevention of hot flashes.
Detailed description
OBJECTIVES: * To evaluate the efficacy of 150 mg of pregabalin versus placebo on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer. * To evaluate the side effect profile of different doses of pregabalin in these patients. * To evaluate the effect of 150 mg of pregabalin versus placebo on the secondary outcome of interference of activities from hot flashes in these patients. * To evaluate the efficacy and side effect profile of 75 mg of pregabalin versus placebo in these patients. OUTLINE: Patients are stratified according to age (18-49 years vs ≥ 50 years); selective estrogen-receptor modulator (i.e., tamoxifen or raloxifene) or aromatase inhibitor use (yes vs no); duration of hot flashes (\< 9 months vs ≥ 9 months); and frequency of hot flashes per 24-hour period (4-9 vs ≥ 10). Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive 75 mg of oral pregabalin twice daily for 6 weeks. * Arm II: Patients receive 150 mg of oral pregabalin twice daily for 6 weeks. * Arm III: Patients receive oral placebo twice daily for 6 weeks. Treatment in all arms continues in the absence of unacceptable toxicity. Patients complete Hot Flash Diaries at baseline and once daily during treatment and the Symptom Experience Diary at baseline and once weekly during treatment. Patients also complete the Profile of Mood States and the Hot Flash Related Daily Interference Scale questionnaires at baseline and after completion of study treatment.
Interventions
DRUGpregabalin
Given orally
OTHERplacebo
Given orally
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
DISEASE CHARACTERISTICS: * Meeting 1 of the following criteria: * History of breast cancer (currently without malignant disease) * No history of breast cancer, but patient wishes to avoid estrogen due to a perceived increased risk of breast cancer * Bothersome hot flashes (defined by their occurrence ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention) * Presence of hot flashes for ≥ 1 month prior to study entry PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Life expectancy ≥ 6 months * Able to complete questionnaire(s) by themselves or with assistance * Women of childbearing potential not eligible (per the judgment of the attending clinician) * Serum creatinine ≤ 1.5 times upper limit of normal PRIOR CONCURRENT THERAPY: * No prior gabapentin or pregabalin * More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents * Vaginal estrogen is allowed if used for the past month and not planned to be discontinued * Concurrent adjuvant targeted therapy (i.e., lapatinib, trastuzumab \[Herceptin®\]) allowed in patients with no evidence of disease * Concurrent tamoxifen, raloxifene, or aromatase inhibitors on a constant dose for at least 4 weeks allowed provided the medication will not be stopped during the study period * No concurrent or planned use of other agents for hot flashes except for any of the following: * Stable dose of vitamin E is allowed as long as agent was started \> 30 days prior to study initiation and is to be continued throughout the study period * Soy is allowed, if it is planned to be continued at the same dose during the study period * Stable dose of antidepressants is allowed as long as it was started \> 30 days prior to study initiation and is to be continued at a stable dose throughout the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | Baseline, after week 6 of treatment | Hot flash activity will be analyzed in a number of ways. For the primary analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA). |
| Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | Baseline, after week 6 of treatment | Hot flash activity will be analyzed in a number of ways. For the primary analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of 75 mg of Pregabalin vs Placebo, Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | Baseline, after week 6 of treatment | Hot flash activity will be analyzed in a number of ways. For the this analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA). |
| Comparison of 75 mg of Pregabalin vs Placebo. Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | Baseline, after week 6 of treatment | Hot flash activity will be analyzed in a number of ways. For the this analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA). |
| Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | Baseline, after week 6 of treatment | The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA). |
| Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Baseline, after week 6 of treatment. | Endpoints for this analysis will be median change from baseline to after week 6 of treatment. Hot Flash Related Daily Interference Scale is used 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. Responses to the questionnaire are recorded on a 0 to 10 scale. Lower scores are better. |
| Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Baseline, 6 weeks during treatment. | A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire weekly. This patient diary contains several questions related to potential side effects and side benefits of pregabalin measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity, providing numbers representing the worst median changes from baseline minus Maximum (Week 1-6) Symptom Experience Diary Distributions). |
| Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | Baseline, after week 6 of treatment | The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA). |
Countries
United States
Participant flow
Recruitment details
Total of 207 patients were enrolled on this trial between 06/20/2008, and 07/21/2008.
Pre-assignment details
There were 16 cancels (6 in Arm I, 3 in Arm II and 7 in Arm III).
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin75 Patients receive 75 mg of oral pregabalin twice daily for 6 weeks. | 63 |
| Pregabalin150 Patients receive 150 mg of oral pregabalin twice daily for 6 weeks. | 66 |
| Placebo Patients receive oral placebo twice daily for 6 weeks. | 62 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 6 | 3 |
| Overall Study | Other Medical Reason/unknown | 1 | 1 | 3 |
| Overall Study | Refusal | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | Pregabalin75 | Pregabalin150 | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 10.6 | 60.6 years STANDARD_DEVIATION 9.5 | 56.6 years STANDARD_DEVIATION 6.4 | 60.3 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment United States | 63 participants | 66 participants | 62 participants | 191 participants |
| Sex: Female, Male Female | 63 Participants | 66 Participants | 62 Participants | 191 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 42 / 63 | 56 / 66 | 37 / 62 |
| serious Total, serious adverse events | 0 / 63 | 0 / 66 | 0 / 62 |
Outcome results
Primary
Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).
Hot flash activity will be analyzed in a number of ways. For the primary analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).
Time frame: Baseline, after week 6 of treatment
Population: Arm II: 66 EPs, 56 are EFP and 10 are not (2 off-study by refusal, 6 AE, 1 unknown reason and 1 NODATA). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin150 | Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -9.6 units on a scale |
| Placebo | Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -6.1 units on a scale |
Comparison: Comparing the median numerical change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.p-value: 0.007t-test, 2 sided
Primary
Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).
Hot flash activity will be analyzed in a number of ways. For the primary analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).
Time frame: Baseline, after week 6 of treatment
Population: Arm II: 66 EPs, 56 are EFP and 10 are not (2 off-study by refusal, 6 AE, 1 unknown reason and 1 NODATA). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin150 | Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -71.0 percent change |
| Placebo | Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -50.1 percent change |
Comparison: Comparing the median percent change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.p-value: 0.007t-test, 2 sided
Secondary
Comparison of 75 mg of Pregabalin vs Placebo, Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).
Hot flash activity will be analyzed in a number of ways. For the this analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).
Time frame: Baseline, after week 6 of treatment
Population: Arm I: 63 EPs, 56 are EFP and 7 are not (3 off-study by refusal, 1 AE, 2 NODATA and 1 due to other medical reasons). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin150 | Comparison of 75 mg of Pregabalin vs Placebo, Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -9.7 units on a scale |
| Placebo | Comparison of 75 mg of Pregabalin vs Placebo, Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -6.1 units on a scale |
Comparison: Comparing the median numerical change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.p-value: 0.002t-test, 2 sided
Secondary
Comparison of 75 mg of Pregabalin vs Placebo. Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).
Hot flash activity will be analyzed in a number of ways. For the this analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).
Time frame: Baseline, after week 6 of treatment
Population: Arm I: 63 EPs, 56 are EFP and 7 are not (3 off-study by refusal, 1 AE, 2 NODATA and 1 due to other medical reasons). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin150 | Comparison of 75 mg of Pregabalin vs Placebo. Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -64.9 percent change |
| Placebo | Comparison of 75 mg of Pregabalin vs Placebo. Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -50.1 percent change |
Comparison: Comparing the median percent change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.p-value: 0.009t-test, 2 sided
Secondary
Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment
Endpoints for this analysis will be median change from baseline to after week 6 of treatment. Hot Flash Related Daily Interference Scale is used 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. Responses to the questionnaire are recorded on a 0 to 10 scale. Lower scores are better.
Time frame: Baseline, after week 6 of treatment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pregabalin150 | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Work | -1.0 units on a scale |
| Pregabalin150 | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Social Activities | -1 units on a scale |
| Pregabalin150 | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Leisure Activities | -1 units on a scale |
| Pregabalin150 | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Sleep | -2 units on a scale |
| Pregabalin150 | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Mood | -1 units on a scale |
| Pregabalin150 | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Concentration | -1 units on a scale |
| Pregabalin150 | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Relations | -1 units on a scale |
| Pregabalin150 | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Sexuality | 0 units on a scale |
| Pregabalin150 | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Enjoy Life | -1 units on a scale |
| Pregabalin150 | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Overall QOL | -1.5 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Enjoy Life | -2 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Work | -1.5 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Concentration | -1 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Mood | -1 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Social Activities | -1.5 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Overall QOL | -1.5 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Sexuality | 0 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Leisure Activities | -1 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Relations | 0 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Sleep | -3 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Sexuality | 0 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Sleep | -1 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Mood | 0 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Concentration | -1 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Enjoy Life | -1 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Relations | 0 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Work | -1 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Overall QOL | 0 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Social Activities | 0 units on a scale |
| Placebo | Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment | Leisure Activities | 0 units on a scale |
Secondary
Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).
The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).
Time frame: Baseline, after week 6 of treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin150 | Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -4.6 Hot flashes per day |
| Placebo | Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -4.9 Hot flashes per day |
| Placebo | Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -2.9 Hot flashes per day |
Secondary
Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).
The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).
Time frame: Baseline, after week 6 of treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin150 | Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -58.5 percent change |
| Placebo | Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -61.1 percent change |
| Placebo | Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). | -36.3 percent change |
Secondary
Toxicity Data for the Individual Study Arms From the Symptom Experience Diary .
A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire weekly. This patient diary contains several questions related to potential side effects and side benefits of pregabalin measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity, providing numbers representing the worst median changes from baseline minus Maximum (Week 1-6) Symptom Experience Diary Distributions).
Time frame: Baseline, 6 weeks during treatment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pregabalin150 | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about concentration | 1.0 units on a scale |
| Pregabalin150 | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about dizziness | 1.0 units on a scale |
| Pregabalin150 | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about blurred/double vision | 0.0 units on a scale |
| Pregabalin150 | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about weight gain | 1.0 units on a scale |
| Pregabalin150 | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about coordination | 0.0 units on a scale |
| Pregabalin150 | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about sleepiness | 1.0 units on a scale |
| Placebo | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about coordination | 1.0 units on a scale |
| Placebo | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about concentration | 1.0 units on a scale |
| Placebo | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about sleepiness | 2.0 units on a scale |
| Placebo | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about blurred/double vision | 1.0 units on a scale |
| Placebo | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about weight gain | 2.0 units on a scale |
| Placebo | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about dizziness | 2.0 units on a scale |
| Placebo | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about blurred/double vision | 0.0 units on a scale |
| Placebo | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about weight gain | 1.0 units on a scale |
| Placebo | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about sleepiness | 1.0 units on a scale |
| Placebo | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about dizziness | 0 units on a scale |
| Placebo | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about coordination | 0.0 units on a scale |
| Placebo | Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . | Concern about concentration | 0.0 units on a scale |