Acupuncture therapy and fatigue assessment and management and hot flashes attenuation in Fatigue and Hot Flashes and Prostate Cancer - Clinical Trials Registry

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Oregon
  - Portland, Oregon, United States, 97239-3098
    - OHSU Knight Cancer Institute
  - Portland, Oregon, United States, 97239
    - Portland VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Weeks 4 after initiation of study treatment.
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.	10 Weeks after initiation of study treatment.
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.	16 Weeks after initiation of study treatment.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	4 Weeks after initiation of study treatment.
Change in biomarkers at baseline after initiation of study treatment Time Frame: Baseline after initiation of study treatment.	Baseline after initiation of study treatment.
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.	10 weeks after initiation of study treatment.
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.	16 Weeks after intiation of study treatment.
Change in biomarkers at 4 weeks after initiation of study treatment Time Frame: 4 Weeks after initiation of study treatment.	4 Weeks after initiation of study treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Tomasz M. Beer, MD, OHSU Knight Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

October 25, 2005

First Submitted That Met QC Criteria