Acupuncture for Hot Flashes in Prostate Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 10 weeks after initiation of study treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion 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
- •Not specified
- •Not specified
- •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
- •See Disease Characteristics
- •No prior placement of a pacemaker or other implantable electrical device
- •More than 4 weeks since prior gabapentin
- •No concurrent antidepressant drugs
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 10 weeks after initiation of study treatment
Time Frame: 10 Weeks after initiation of study treatment.
Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 4 weeks after initiation of study treatment
Time Frame: Weeks 4 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
Time Frame: 16 Weeks after initiation of study treatment.
Secondary Outcomes
- 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.)
Investigators
Tom Beer
Principal Investigator
OHSU Knight Cancer Institute