Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer
This study has been terminated.
Sponsor:
OHSU Knight Cancer Institute
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00244894
First received: October 25, 2005
Last updated: August 29, 2011
Last verified: August 2011
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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 therapy Procedure: fatigue assessment and management Procedure: hot flashes attenuation Procedure: management of therapy complications Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Acupuncture for Hot Flashes in Prostate Cancer Patients |
Resource links provided by NLM:
Further study details as provided by OHSU Knight Cancer Institute:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: 4 Weeks after initiation of study treatment. ] [ Designated as safety issue: No ]
- Change in biomarkers at baseline after initiation of study treatment [ Time Frame: Baseline after initiation of study treatment. ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 10 weeks after initiation of study treatment. ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 16 Weeks after intiation of study treatment. ] [ Designated as safety issue: No ]
- Change in biomarkers at 4 weeks after initiation of study treatment [ Time Frame: 4 Weeks after initiation of study treatment. ] [ Designated as safety issue: No ]
| Enrollment: | 22 |
| Study Start Date: | September 2002 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
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 older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244894
Locations
| United States, Oregon | |
| OHSU Knight Cancer Institute | |
| Portland, Oregon, United States, 97239-3098 | |
| Portland VA Medical Center | |
| Portland, Oregon, United States, 97239 | |
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
| Principal Investigator: | Tomasz M. Beer, MD | OHSU Knight Cancer Institute |
More Information
No publications provided
| Responsible Party: | OHSU Knight Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00244894 History of Changes |
| Other Study ID Numbers: | CDR0000445180, OHSU-7235, OHSU-HOR-02029-LX |
| Study First Received: | October 25, 2005 |
| Last Updated: | August 29, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by OHSU Knight Cancer Institute:
|
fatigue recurrent prostate cancer stage II prostate cancer |
stage III prostate cancer stage IV prostate cancer hot flashes |
Additional relevant MeSH terms:
|
Fatigue Prostatic Neoplasms Hot Flashes Signs and Symptoms Genital Neoplasms, Male |
Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013