Acupuncture for Hot Flashes in Prostate Cancer Patients
18 Years
N/A
Male
Fatigue, Hot Flashes, Prostate Cancer
Trial Information
Acupuncture for Hot Flashes in Prostate Cancer Patients
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.
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
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 4 weeks after initiation of study treatment
Outcome Time Frame:
Weeks 4 after initiation of study treatment.
Safety Issue:
No
Principal Investigator
Tomasz M. Beer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000445180
NCT ID:
NCT00244894
Start Date:
September 2002
Completion Date:
April 2010
Related Keywords:
- Fatigue
- Hot Flashes
- Prostate Cancer
- fatigue
- recurrent prostate cancer
- stage II prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- hot flashes
- Fatigue
- Prostatic Neoplasms
- Hot Flashes
Name | Location |
|---|---|
| OHSU Knight Cancer Institute | Portland, Oregon 97239 |
| Portland VA Medical Center | Portland, Oregon 97239 |
