Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

OHSU Knight Cancer Institute

Status: Terminated

Conditions: Hot Flashes; Fatigue; Prostate Cancer

Treatments: Procedure: hot flashes attenuation; Procedure: acupuncture therapy; Procedure: fatigue assessment and management; Procedure: quality-of-life assessment; Procedure: management of therapy complications

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00244894

OHSU-7235

CDR0000445180

OHSU-HOR-02029-LX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Male

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)