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| ID | Type | Description | Link |
|---|---|---|---|
| OHSU-7235 | |||
| OHSU-HOR-02029-LX |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture therapy | Procedure | 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 | Procedure | 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 | Procedure | 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 | Procedure | Short Form Health Survey (SF-36) will be used to assess the patient's overall vitality. |
| 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. |
| 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 |
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DISEASE CHARACTERISTICS:
Confirmed diagnosis of prostate cancer
Hot flash score ≥ 4 per day
Prior or concurrent treatment with 1 of the following :
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz M. Beer, MD | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239-3098 | United States | ||
| Portland VA Medical Center |
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| quality-of-life assessment | Procedure | Hot Flash Related Daily Interference Scale (HFRDIS)will be used to self-report hot flash related quality of life. |
| 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. |
| Portland |
| Oregon |
| 97239 |
| United States |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D019584 | Hot Flashes |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
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