Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

October 25, 2005

Last Updated Date

September 30, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 4, 10, and 16 weeks after initiation of study treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00244894 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Improved quality of life as measured by HFR-QOL and elements of SF-36 at 4, 10, and 16 weeks after initiation of study treatment
Change in biomarkers at baseline and 4 weeks after initiation of study treatment

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

Official Title ^ICMJE

Acupuncture for Hot Flashes in Prostate Cancer Patients

Brief Summary

RATIONALE: Acupuncture may help relieve hot flashes in patients with prostate cancer.

PURPOSE: This clinical trial is studying how well acupuncture works in treating hot flashes in patients with prostate cancer who are undergoing androgen deprivation.

Detailed Description

OBJECTIVES:

Determine the impact of acupuncture therapy on the frequency and intensity of hot flashes and the quality of life of patients with prostate cancer undergoing androgen deprivation.
Determine if blood serotonin and urinary 5-HIAA are increased in patients treated with acupuncture.
Determine if plasma calcitonin gene-related peptide and MHPG are reduced in patients with hot flashes due to androgen deprivation treated with acupuncture.
Determine the ability of tongue diagnosis, a traditional Chinese clinical assessment method, to predict clinical and biological changes in these patients.
Determine the effect of acupuncture on insomnia and loss of vitality caused by hot flashes in these patients.

OUTLINE: Patients undergo acupuncture for 30 minutes twice weekly for 4 weeks and then once weekly for an additional 6 weeks.

Quality of life is assessed at baseline, at weeks 2, 4, 6, and 10, and then at 6 weeks after completion of study treatment.

After completion of study treatment, patients are followed at 6 weeks.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Open Label

Condition ^ICMJE

Fatigue
Hot Flashes
Prostate Cancer

Intervention ^ICMJE

Procedure: acupuncture therapy
Procedure: fatigue assessment and management
Procedure: hot flashes attenuation
Procedure: management of therapy complications
Procedure: quality-of-life assessment

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Confirmed diagnosis of prostate cancer
Hot flash score ≥ 4 per day
Prior or concurrent treatment with 1 of the following :
- Bilateral orchiectomy
- Gonadotropin releasing-hormone (GnRH) agonist or antagonist therapy
- Antiandrogen therapy

PATIENT CHARACTERISTICS:

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No mental impairment

PRIOR CONCURRENT THERAPY:

Chemotherapy

No concurrent chemotherapy

Endocrine therapy

See Disease Characteristics
More than 4 weeks since prior estrogen or progestational drugs

Surgery

See Disease Characteristics
No prior placement of a pacemaker or other implantable electrical device

Other

More than 4 weeks since prior gabapentin
No concurrent antidepressant drugs

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00244894

Responsible Party

Tomasz M. Beer, MD, OHSU Knight Cancer Institute

Study ID Numbers ^ICMJE

CDR0000445180, OHSU-7235, OHSU-HOR-02029-LX

Study Sponsor ^ICMJE

OHSU Knight Cancer Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Tomasz M. Beer, MD

OHSU Knight Cancer Institute

Information Provided By

OHSU Knight Cancer Institute

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP