NCT00244894

Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

Acupuncture for Hot Flashes in Prostate Cancer Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fatigue
• Hot Flashes
• Prostate Cancer

Interventions

Type	Name	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.

Timeline

• Start date: 2002-09-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2005-10-27
• Last updated: 2017-04-28

Locations

2 sites across 1 country: United States