Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

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. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Official Title
-----------------
Acupuncture for Hot Flashes in Prostate Cancer Patients

Conditions
-----------------
Fatigue, Hot Flashes, Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: acupuncture therapy
* Procedure: fatigue assessment and management
* Procedure: hot flashes attenuation
* Procedure: management of therapy complications
* Procedure: quality-of-life assessment


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 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|
|Procedure: 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.|
|Procedure: 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.|
|Procedure: management of therapy complications|Short Form Health Survey (SF-36) will be used to assess the patient's overall vitality.|
|Procedure: quality-of-life assessment|Hot Flash Related Daily Interference Scale (HFRDIS)will be used to self-report hot flash related quality of life.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fatigue, recurrent prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, hot flashes