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

Breast Neoplasms Clinical Trial

Official title:

Desvenlafaxine for the Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen: a Randomized, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02819921
• Other study ID #: WI209149
• Status: Terminated
• Phase: Phase 4
• Start date: November 10, 2017
• Est. completion date: June 15, 2019

Study information

• Verified date: September 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: June 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Hot Flashes

Intervention

Drug:
• Desvenlafaxine succinate 100mg
Pristiq 100mg
• Desvenlafaxine succinate 50mg
Pristiq 50mg
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Seoul National University Hospital	Korea Cancer Center Hospital, Pfizer, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to Week 5 (Intervention is started from Week 1)
Secondary	Clinical impression state and change	Clinical global impression (CGI) would be used to assess clinical impression state and change.	Week 1, Week 2, Week 5
Secondary	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.	Week 1, Week 2, Week 5
Secondary	Depression	Patient health questionnaire (PHQ-9) would be used to assess mood status.	Baseline, Week 2, Week 5
Secondary	Anxiety	Generalized anxiety disorder-7 (GAD-7) would be used to assess anxiety.	Baseline, Week 2, Week 5
Secondary	Manic or Hypomanic symptoms.	Mood disorder questionnaire (MDQ) would be used to assess manic or hypomanic symptoms.	Baseline, Week 2, Week 5
Secondary	Sleep quality	Pittsburgh sleep quality index (PSQI) would be used to assess sleep quality.	Baseline, Week 2, Week 5
Secondary	Chonotype	Morningness-Eveningness questionnaire (MEQ) would be used to assess chronotype.	Baseline
Secondary	Circadian misalignment	Munich Chronotype Questionnaire (MCTQ) would be used to assess circadian misalignment.	Baseline, Week 2, Week 5
Secondary	Fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) would be used to assess fatigue.	Baseline, Week 2, Week 5
Secondary	Quality of life	Functional Assessment of Cancer Therapy-Breast (FACT-B) would be used to assess quality of life.	Baseline, Week 2, Week 5
Secondary	Beliefs about medicines	Beliefs about Medicines Questionnaire (BMQ) would be used to assess beliefs about medicines.	Baseline
Secondary	Illness perception	Brief Illness Perception Questionnaire (BIPQ) would be used to assess illness perception.	Baseline
Secondary	Social support	Multidimensional Scale of Perceived Social Support (MSPSS) would be used to assess social supports.	Baseline
Secondary	Body image	Body Image Scale (BIS) would be used to assess body image.	Baseline
Secondary	Resilience	Connor-Davidson Resilience Scale (CDRS) would be used to assess resilience.	Baseline
Secondary	Hormonal level	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.	Week 2
Secondary	Genetic polymorphism	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.	Week 2