Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Acupuncture for Hot Flashes in Prostate Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00244894
• Other study ID #: CDR0000445180
• Secondary ID: OHSU-7235OHSU-HO
• Status: Terminated
• Phase: N/A
• First received: October 25, 2005
• Last updated: April 26, 2017
• Start date: September 2002
• Est. completion date: April 2010

Study information

• Verified date: April 2017
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Hot Flashes
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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
• 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.
• 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.
• management of therapy complications
Short Form Health Survey (SF-36) will be used to assess the patient's overall vitality.
• quality-of-life assessment
Hot Flash Related Daily Interference Scale (HFRDIS)will be used to self-report hot flash related quality of life.

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	Portland VA Medical Center	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	Change in biomarkers at baseline after initiation of study treatment		Baseline after initiation of study treatment.
Secondary	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.
Secondary	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.
Secondary	Change in biomarkers at 4 weeks after initiation of study treatment		4 Weeks after initiation of study treatment.