Clinical trial NCT02819921: Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen
Official title: Desvenlafaxine for the Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen: a Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hot Flashes
Breast Neoplasms
Keywords: Hot Flashes
Breast Neoplasms
Tamoxifen
Desvenlafaxine Succinate
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Korea Cancer Center Hospital
name: Pfizer
First posted: 2016-06-30
Enrollment: 59
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction rate of hot flashes symptom score
timeFrame: From baseline to Week 5 (Intervention is started from Week 1)
Secondary outcomes:
measure: Clinical impression state and change
timeFrame: Week 1, Week 2, Week 5
measure: Peripheral neuropathy
timeFrame: Week 1, Week 2, Week 5
measure: Depression
timeFrame: Baseline, Week 2, Week 5
measure: Anxiety
timeFrame: Baseline, Week 2, Week 5
measure: Manic or Hypomanic symptoms.
timeFrame: Baseline, Week 2, Week 5
measure: Sleep quality
timeFrame: Baseline, Week 2, Week 5
measure: Chonotype
timeFrame: Baseline
measure: Circadian misalignment
timeFrame: Baseline, Week 2, Week 5
measure: Fatigue
timeFrame: Baseline, Week 2, Week 5
measure: Quality of life
timeFrame: Baseline, Week 2, Week 5
measure: Beliefs about medicines
timeFrame: Baseline
measure: Illness perception
timeFrame: Baseline
measure: Social support
timeFrame: Baseline
measure: Body image
timeFrame: Baseline
measure: Resilience
timeFrame: Baseline
measure: Hormonal level
timeFrame: Week 2
measure: Genetic polymorphism
timeFrame: Week 2
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Bong-Jin Hahm, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: