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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)

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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  25
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 No
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.




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