Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

Sponsor

OHSU Knight Cancer Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT00244894

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Acupuncture for Hot Flashes in Prostate Cancer Patients

Study Start Date :

Sep 1, 2002

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Improved quality of life as measured by hot flash related-quality of life (HFR-QOL) and elements of short form health survey (SF-36) at 4 weeks after initiation of study treatment [4 Weeks after initiation of study treatment.]
Change in biomarkers at baseline after initiation of study treatment [Baseline after initiation of study treatment.]
Improved quality of life as measured by hot flash related-quality of life (HFR-QOL) and elements of short form health survey (SF-36) at 10 weeks after initiation of study treatment [10 weeks after initiation of study treatment.]
Improved quality of life as measured by hot flash related-quality of life (HFR-QOL) and elements of short form health survey (SF-36) at 16 weeks after initiation of study treatment [16 Weeks after intiation of study treatment.]
Change in biomarkers at 4 weeks after initiation of study treatment [4 Weeks after initiation of study treatment.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	OHSU Knight Cancer Institute	Portland	Oregon	United States	97239-3098
2	Portland VA Medical Center	Portland	Oregon	United States	97239

Sponsors and Collaborators

OHSU Knight Cancer Institute
National Cancer Institute (NCI)

Investigators

Principal Investigator: Tomasz M. Beer, MD, OHSU Knight Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tom Beer, Principal Investigator, OHSU Knight Cancer Institute

ClinicalTrials.gov Identifier:

NCT00244894

Other Study ID Numbers:

CDR0000445180
OHSU-7235
OHSU-HOR-02029-LX

First Posted:

Oct 27, 2005

Last Update Posted:

Apr 28, 2017

Last Verified:

Apr 1, 2017

Keywords provided by Tom Beer, Principal Investigator, OHSU Knight Cancer Institute

fatigue

recurrent prostate cancer

stage II prostate cancer

stage III prostate cancer

stage IV prostate cancer

hot flashes

Additional relevant MeSH terms:

Prostatic Neoplasms

Fatigue

Hot Flashes

Study Results

No Results Posted as of Apr 28, 2017