Venlafaxine for Hot Flashes After Breast Cancer
Information source: Indiana University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: venlafaxine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Indiana University School of Medicine Official(s) and/or principal investigator(s):
Janet S Carpenter, PhD, Principal Investigator, Affiliation: Indiana University School of Medicine
Summary
The purpose of this study is to evaluate Venlafaxine as a treatment option for hot flashes in
breast cancer survivors. The goals of this study are to assess the effectiveness and toxicity
of venlafaxine hydrochloride and identify the psychological, behavioral, and physical
outcomes associated with relief of hot flashes in women following treatment for breast
cancer.
Clinical Details
Official title: Venlafaxine for Hot Flashes After Breast Cancer
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: -Assess the effectiveness venlafaxine hydrochloride versus placebo in alleviating hot flash frequency, severity, distress, and magnitude in women following treatment for breast cancer.
Secondary outcome: Identify the psychological, behavioral, and physical outcomes associated with relief of hot flashes in women following treatment for breast cancer.
Detailed description:
Hot flashes are the most severe and fourth most prevalent menopausal symptom reported by
women with breast cancer. Hot flashes affect over 65% of this population, with 59% rating the
symptom as severe and 44% reporting they are extremely distressed by the symptom. Despite the
high prevalence, severity and distress associated with this symptom, the scientific basis for
managing hot flashes in women with breast cancer is limited. This randomized, double-blind,
placebo-controlled crossover trial examines the effectiveness and toxicity of sustained
release venlafaxine hydrochloride (37. 5 mg po qd) on hot flashes in women following treatment
for breast cancer. Venlafaxine is a phenylethylamine derivative that potently inhibits the
reuptake of neuronal serotonin and norepinephrine and weakly inhibits the reuptake of
dopamine. A secondary aim of this project is to examine the impact of hot flashes on
psychological, behavioral, and physical outcomes. This study is based on the Wickham Symptom
Management Model which depicts interrelationships between symptoms, symptom management
strategies, and symptom management outcomes. Participants (n = 80) who are at least one month
post-completion of surgery, radiation, and/or chemotherapy and who have been on tamoxifen (if
prescribed) for at least six weeks will complete a two-week baseline hot flash assessment and
be randomized to one arm of the crossover trial. At the end of the first six-week arm,
participants will crossover to the opposite study arm for an additional six weeks. Outcomes
to be assessed include effectiveness of the intervention (hot flash frequency, severity,
distress and magnitude), toxicity of the intervention (subjective preference, side effects),
psychological outcomes (mood disturbance), behavioral outcomes (quality of life, interference
with daily activities) and physical outcomes (fatigue and sleep disturbance). Hot flashes
will be measured daily, using a subjective, prospective diary methodology, and weekly, using
objective state-of-the art 24-hour physiological monitoring of sternal skin conductance.
Other outcomes will be measured weekly. Compliance with the intervention/placebo will be
assessed weekly using medication blister pack cards. Timing of outcome assessments is based
on limitations of the physiological monitoring device and expected timing of treatment
effects. Summary statistics (i. e., mean, slope, maximum response, range, proportion,
achievable difference) will be used to effectively reduce the design to a 2 X 2 crossover and
data will be analyzed accordingly (i. e., t-tests, linear regression, GEE, mixed model). Study
findings will significantly contribute to the scientific basis of hot flash management in
women following treatment for breast cancer.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- women at least 21 years of age
- willing and able to provide informed consent
- first time diagnosis of breast cancer
- no other history of cancer
- considered disease free at time of study enrollment
- at least four weeks post-completion of surgery, radiation, and/or chemotherapy for
non-metastatic cancer
- experiencing daily hot flashes
- desirous of treatment for hot flashes, but not concurrently using any other hot flash
treatments
- living within 60 miles of Indianapolis
- able to read, write and speak English
Exclusion Criteria:
- current treatment with antidepressants for depression, neuropathic pain or hot
flashes
- diagnosis of metastatic breast cancer (stage IV)
- treatment for hot flashes within the past four weeks, including (a) soy supplements;
(b) botanicals, such as dong quai (Angelica sinensis), black cohosh, ginseng, gotu
kola, licorice root, chaste tree, sage, or wild yam root; (c) vitamin E; or (d)
prescription medications, such as clonidine hydrochloride or megestrol acetate.
Locations and Contacts
Indiana University Cancer Center, Indianapolis, Indiana 46202, United States
Additional Information
Starting date: May 2000
Ending date: November 2005
Last updated: November 5, 2007
|
