Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer
NCT ID: NCT00244894
Last Updated: 2017-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
22 participants
INTERVENTIONAL
2002-09-30
2010-04-30
Brief Summary
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PURPOSE: This clinical trial is studying how well acupuncture works in treating hot flashes in patients with prostate cancer who are undergoing androgen deprivation.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Interventions
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acupuncture therapy
Acupuncture treatments will be administered by a qualified practitioner twice a week for the first four weeks and once per week for an additional 6 weeks. Sterile, disposable Seirin needles will be placed bilaterally at the point Gallbladder 34, and along the spine at Bladder 15, Bladder 23, and Bladder 32. Low intensity electrostimulation at 2 Hz will be used for both Bladder 23 and Bladder 32. Points will also be placed unilaterally at Governing vessel 20, Heart 7, Pericardium 6, Liver 2, and Spleen 6
fatigue assessment and management
Patients will utilize the Pittsburgh Sleep Quality Index (PSQI) to assess if the patient is an overall good sleeper or a poor sleeper.
hot flashes attenuation
Patients will be asked to report hot flash frequency and severity daily using the hot flash diary (HFD) and hot flash severity guidelines (HFSG) throughout the treatment period.
management of therapy complications
Short Form Health Survey (SF-36) will be used to assess the patient's overall vitality.
quality-of-life assessment
Hot Flash Related Daily Interference Scale (HFRDIS)will be used to self-report hot flash related quality of life.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Tom Beer
Principal Investigator
Principal Investigators
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Tomasz M. Beer, MD
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Locations
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OHSU Knight Cancer Institute
Portland, Oregon, United States
Portland VA Medical Center
Portland, Oregon, United States
Countries
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Other Identifiers
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OHSU-7235
Identifier Type: -
Identifier Source: secondary_id
OHSU-HOR-02029-LX
Identifier Type: -
Identifier Source: secondary_id
CDR0000445180
Identifier Type: -
Identifier Source: org_study_id
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