Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT00244894
Status:
TERMINATED
Last Update Posted:
2017-04-28
First Post:
2005-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
Acupuncture for Hot Flashes in Prostate Cancer Patients
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: