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Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

This study has been completed.

Sponsors and Collaborators: Oregon Health and Science University Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00244894
  Purpose

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.


Condition Intervention
Fatigue
Hot Flashes
Prostate Cancer
Procedure: acupuncture therapy
Procedure: fatigue assessment and management
Procedure: hot flashes attenuation
Procedure: management of therapy complications
Procedure: quality-of-life assessment

MedlinePlus related topics:   Acupuncture   Cancer   Prostate Cancer  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Open Label
Official Title:   Acupuncture for Hot Flashes in Prostate Cancer Patients

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 Measures:
  • 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

Estimated Enrollment:   25
Study Start Date:   September 2002
Primary Completion Date:   December 2007 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244894

Locations
United States, Oregon
Oregon Health & Science University Cancer Institute    
      Portland, Oregon, United States, 97239-3098

Sponsors and Collaborators
Oregon Health and Science University Cancer Institute
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Tomasz M. Beer, MD     Oregon Health and Science University Cancer Institute    
  More Information

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

Study ID Numbers:   CDR0000445180, OHSU-7235, OHSU-HOR-02029-LX
First Received:   October 25, 2005
Last Updated:   March 17, 2008
ClinicalTrials.gov Identifier:   NCT00244894
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
fatigue  
recurrent prostate cancer  
stage II prostate cancer  
stage III prostate cancer
stage IV prostate cancer
hot flashes

Study placed in the following topic categories:
Fatigue
Prostatic Diseases
Genital Neoplasms, Male
Hot Flashes
Urogenital Neoplasms
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Signs and Symptoms
Neoplasms
Neoplasms by Site
Genital Diseases, Male

ClinicalTrials.gov processed this record on July 03, 2008




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