Venlafaxine for Hot Flashes After Breast Cancer

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University School of Medicine
• Collaborators: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Venlafaxine Hydrochloride

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.