Clinical trial NCT00244894: Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer
Official title: Acupuncture for Hot Flashes in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fatigue
Hot Flashes
Prostate Cancer
Keywords: fatigue
recurrent prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
hot flashes
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-10-27
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 4 weeks after initiation of study treatment
timeFrame: Weeks 4 after initiation of study treatment.
measure: Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 10 weeks after initiation of study treatment
timeFrame: 10 Weeks after initiation of study treatment.
measure: Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 16 weeks after initiation of study treatment
timeFrame: 16 Weeks after initiation of study treatment.
Secondary outcomes:
measure: 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
timeFrame: 4 Weeks after initiation of study treatment.
measure: Change in biomarkers at baseline after initiation of study treatment
timeFrame: Baseline after initiation of study treatment.
measure: 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
timeFrame: 10 weeks after initiation of study treatment.
measure: 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
timeFrame: 16 Weeks after intiation of study treatment.
measure: Change in biomarkers at 4 weeks after initiation of study treatment
timeFrame: 4 Weeks after initiation of study treatment.
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Tomasz M. Beer, MD
role: PRINCIPAL_INVESTIGATOR
References: