Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

Not Applicable

Terminated

• Conditions: Fatigue; Hot Flashes; Prostate Cancer

• Registration Number: NCT00244894
• Lead Sponsor: OHSU Knight Cancer Institute

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-10-25
• Study First Submitted QC: 2005-10-25
• Study First Posted: 2005-10-27
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Portland VA Medical Center; 🇺🇸 Portland, Oregon, United States

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States