NCT00198250

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started May 2000

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

November 14, 2008

Status Verified

November 1, 2008

Enrollment Period

5.5 years

First QC Date

September 15, 2005

Last Update Submit

November 13, 2008

Conditions

Breast Cancer

Keywords

Breast cancer survivorshiphot flashestreatment

Outcome Measures

Primary Outcomes (1)

  • Assess the effectiveness venlafaxine hydrochloride versus placebo in alleviating hot flash frequency, severity, distress, and magnitude in women following treatment for breast cancer.

    completed

Secondary Outcomes (1)

  • Identify the psychological, behavioral, and physical outcomes associated with relief of hot flashes in women following treatment for breast cancer.

    completed

Interventions

venlafaxineDRUG

Venlafaxine taper dose from 37.5mg for one week to 75 mg for 3 weeks

Also known as: Effexor

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Carpenter JS, Storniolo AM, Johns S, Monahan PO, Azzouz F, Elam JL, Johnson CS, Shelton RC. Randomized, double-blind, placebo-controlled crossover trials of venlafaxine for hot flashes after breast cancer. Oncologist. 2007 Jan;12(1):124-35. doi: 10.1634/theoncologist.12-1-124.

    PMID: 17227907RESULT

MeSH Terms

Conditions

Breast NeoplasmsHot Flashes

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Officials

  • Janet S Carpenter, PhD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 20, 2005

Study Start

May 1, 2000

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

November 14, 2008

Record last verified: 2008-11

Locations

US(1)