Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer
This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) November 2005
| Sponsors and Collaborators: |
Oregon Health and Science University
|
| 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
Procedure: alternative medical systems
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: complications of therapy assessment/management
Procedure: fatigue assessment/management
Procedure: hot flashes attenuation
Procedure: menopausal symptoms attenuation
Procedure: quality-of-life assessment
Procedure: supportive care/therapy
|
MedlinePlus related topics: Menopause; Prostate Cancer
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 Outcomes: 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 Outcomes: 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
Expected Total Enrollment: 25
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 above, Genders Eligible for Study: Both
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
Life expectancy
Hematopoietic
Hepatic
Renal
Other
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00244894
Oregon
Oregon Health & Science University Cancer Institute, Portland, Oregon, 97239-3098, United States; Recruiting
Tomasz M. Beer, MD 503-494-8108
Study chairs or principal investigators
Tomasz M. Beer, MD, Principal Investigator, Oregon Health and Science University
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000445180; OHSU-7235; OHSU-HOR-02029-LX
Last Updated: November 8, 2006
Record first received: October 25, 2005
ClinicalTrials.gov Identifier:
NCT00244894
Health Authority: Unspecified
(National Cancer Institute)
(Patient Education Institute) - Requires Flash Player