Breast Neoplasms, Hot Flashes
Conditions
Keywords
Hot Flashes, Breast Neoplasms, Tamoxifen, Desvenlafaxine Succinate
Brief summary
This study is a randomized, placebo-controlled study of desvenlafaxine versus placebo. The purpose of this study is to determine if desvenlafaxine was effective in decreasing the frequency and severity of hot flashes in breast cancer patients taking tamoxifen.
Interventions
DRUGDesvenlafaxine succinate 100mg
Pristiq 100mg
DRUGDesvenlafaxine succinate 50mg
Pristiq 50mg
DRUGPlacebo
Placebo
Sponsors
Seoul National University Bundang Hospital
Korea Cancer Center Hospital
Pfizer
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i. Women age 18 years and older with localized breast cancer. Histologic documentation of atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive adenocarcinoma of the breast stages I-III A. ii. Current daily tamoxifen use (≥ 6 days/week). Any planned surgery, adjuvant chemotherapy or radiation must have been completed. iii. History of bothersome hot flushes: ≥ 14 hot flushes/week (average ≥ 2 hot flushes/day), sufficiently severe that intervention is desired. Participants must have had bothersome hot flushes for at least one month prior to enrollment.
Exclusion criteria
i. Women who is pregnant or breast feeding, or who has a history of seizure disorder or hepatic or renal insufficiency ii. Concurrent systemic hormone replacement therapy (estrogen, progestational agents, androgens) or use of corticosteroids iii. Concurrent use of other antidepressants, anxiolytics and antipsychotics, gabapentin, pregabalin and clonidine for treatment of hot flushes or depression. iv. Presense or past history of severe psychiatric symptoms such as hallucinations and delusions, manic episodes, or high suicide risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction rate of hot flashes symptom score | From baseline to Week 5 (Intervention is started from Week 1) | Participants would complete self -report daily diary on which they record the number and severities (1 - 4 points) of hot flashes from baseline to week 5. Each symptom severities are multiplied by the numbers of symptoms to determine the daily hot flashes symptom score. The mean of daily hot flashes symptom score of one week is calculated and regared as a hot flashes symptom score for the week. The efficacy of Desvenlafaxine is assessed by comparing the reduction rate of weekly hot flashes symptom score (= hot flashes symptom score at week 5 - hot flashes symptom score at baseline / hot flashes symptom score of baseline) for each group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral neuropathy | Week 1, Week 2, Week 5 | European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy(EORTC-QLQ-CIPN-20) would be used to assess peripheral neuropathy. |
| Depression | Baseline, Week 2, Week 5 | Patient health questionnaire (PHQ-9) would be used to assess mood status. |
| Anxiety | Baseline, Week 2, Week 5 | Generalized anxiety disorder-7 (GAD-7) would be used to assess anxiety. |
| Manic or Hypomanic symptoms. | Baseline, Week 2, Week 5 | Mood disorder questionnaire (MDQ) would be used to assess manic or hypomanic symptoms. |
| Sleep quality | Baseline, Week 2, Week 5 | Pittsburgh sleep quality index (PSQI) would be used to assess sleep quality. |
| Chonotype | Baseline | Morningness-Eveningness questionnaire (MEQ) would be used to assess chronotype. |
| Circadian misalignment | Baseline, Week 2, Week 5 | Munich Chronotype Questionnaire (MCTQ) would be used to assess circadian misalignment. |
| Fatigue | Baseline, Week 2, Week 5 | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) would be used to assess fatigue. |
| Clinical impression state and change | Week 1, Week 2, Week 5 | Clinical global impression (CGI) would be used to assess clinical impression state and change. |
| Beliefs about medicines | Baseline | Beliefs about Medicines Questionnaire (BMQ) would be used to assess beliefs about medicines. |
| Illness perception | Baseline | Brief Illness Perception Questionnaire (BIPQ) would be used to assess illness perception. |
| Social support | Baseline | Multidimensional Scale of Perceived Social Support (MSPSS) would be used to assess social supports. |
| Body image | Baseline | Body Image Scale (BIS) would be used to assess body image. |
| Resilience | Baseline | Connor-Davidson Resilience Scale (CDRS) would be used to assess resilience. |
| Hormonal level | Week 2 | Serum estradiol, follicle-stimulating hormone (FSH) and anti-Müllerian hormone (AMH) levels would be used to examine pathophysiological mechanisms associated with the presence of hot flashes, mood status and desvenlafaxine treatment. |
| Genetic polymorphism | Week 2 | estrogen receptors (ESR1 PvuII; rs#2234693 and XbaI; rs#9340799 and ESR2-02; rs#4986938) and serotonin transporter gene (SLC6A4; rs#11080121) would be used to examine pathophysiological mechanisms associated with the presence of hot flashes, mood status and desvenlafaxine treatment. |
| Quality of life | Baseline, Week 2, Week 5 | Functional Assessment of Cancer Therapy-Breast (FACT-B) would be used to assess quality of life. |
Countries
South Korea
Outcome results
None listed