Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen

Phase 4TerminatedNCT02819921

Seoul National University Hospital59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hot Flashes Breast Neoplasms

Interventions

Desvenlafaxine succinate 100mgDRUG

Pristiq 100mg

Desvenlafaxine succinate 50mgDRUG

Pristiq 50mg

PlaceboDRUG

Placebo

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (3)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Reduction rate of hot flashes symptom score

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.

Time frame: From baseline to Week 5 (Intervention is started from Week 1)

Secondary Outcomes

Clinical impression state and change

Clinical global impression (CGI) would be used to assess clinical impression state and change.

Time frame: Week 1, Week 2, Week 5

Peripheral neuropathy

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.

Time frame: Week 1, Week 2, Week 5

Depression

Patient health questionnaire (PHQ-9) would be used to assess mood status.

Time frame: Baseline, Week 2, Week 5

Anxiety

Generalized anxiety disorder-7 (GAD-7) would be used to assess anxiety.

Time frame: Baseline, Week 2, Week 5

Manic or Hypomanic symptoms.

Mood disorder questionnaire (MDQ) would be used to assess manic or hypomanic symptoms.

Data from ClinicalTrials.gov

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