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

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Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

This study has been completed.
Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

Official Title ^†

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 ^†

Interventional

Study Design ^†

Supportive Care, Open Label

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Fatigue
Hot Flashes
Prostate Cancer

Intervention ^†

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

MEDLINE PMIDs

Links

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

September 2002

Completion Date

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00244894

Organization ID

CDR0000445180

Secondary IDs ^††

OHSU-7235, OHSU-HOR-02029-LX

Study Sponsor ^†

Oregon Health and Science University Cancer Institute

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Principal Investigator:

Tomasz M. Beer, MD

Oregon Health and Science University Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2007

First Received Date ^†

October 25, 2005

Last Updated Date

March 17, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.