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Acupuncture for Hot Flashes in Prostate Cancer Patients


N/A
18 Years
N/A
Not Enrolling
Male
Fatigue, Hot Flashes, Prostate Cancer

Thank you

Trial Information

Acupuncture for Hot Flashes in Prostate Cancer Patients


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome 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

Outcome Time Frame:

Weeks 4 after initiation of study treatment.

Safety Issue:

No

Principal Investigator

Tomasz M. Beer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000445180

NCT ID:

NCT00244894

Start Date:

September 2002

Completion Date:

April 2010

Related Keywords:

  • Fatigue
  • Hot Flashes
  • Prostate Cancer
  • fatigue
  • recurrent prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • hot flashes
  • Fatigue
  • Prostatic Neoplasms
  • Hot Flashes

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239
Portland VA Medical CenterPortland, Oregon  97239