Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00244894
First received: October 25, 2005
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Fatigue
Hot Flashes
Prostate Cancer
Procedure: acupuncture therapy
Procedure: fatigue assessment and management
Procedure: hot flashes attenuation
Procedure: management of therapy complications
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Acupuncture for Hot Flashes in Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 4 weeks after initiation of study treatment [ Time Frame: Weeks 4 after initiation of study treatment. ] [ Designated as safety issue: No ]
  • Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 10 weeks after initiation of study treatment [ Time Frame: 10 Weeks after initiation of study treatment. ] [ Designated as safety issue: No ]
  • Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 16 weeks after initiation of study treatment [ Time Frame: 16 Weeks after initiation of study treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 4 Weeks after initiation of study treatment. ] [ Designated as safety issue: No ]
  • Change in biomarkers at baseline after initiation of study treatment [ Time Frame: Baseline after initiation of study treatment. ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 10 weeks after initiation of study treatment. ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 16 Weeks after intiation of study treatment. ] [ Designated as safety issue: No ]
  • Change in biomarkers at 4 weeks after initiation of study treatment [ Time Frame: 4 Weeks after initiation of study treatment. ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: September 2002
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244894

Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Portland VA Medical Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Tomasz M. Beer, MD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00244894     History of Changes
Other Study ID Numbers: CDR0000445180, OHSU-7235, OHSU-HOR-02029-LX
Study First Received: October 25, 2005
Last Updated: August 29, 2011
Health Authority: United States: Federal Government

Keywords provided by OHSU Knight Cancer Institute:
fatigue
recurrent prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
hot flashes

Additional relevant MeSH terms:
Prostatic Neoplasms
Fatigue
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014