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Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

Primary Purpose

Fatigue, Hot Flashes, Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acupuncture therapy
fatigue assessment and management
hot flashes attenuation
management of therapy complications
quality-of-life assessment
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring fatigue, recurrent prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, hot flashes

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • OHSU Knight Cancer Institute
  • Portland VA Medical Center

Outcomes

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
Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 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

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
Change in biomarkers at 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
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
Change in biomarkers at 4 weeks after initiation of study treatment

Full Information

First Posted
October 25, 2005
Last Updated
April 26, 2017
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00244894
Brief Title
Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer
Official Title
Acupuncture for Hot Flashes in Prostate Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Study Start Date
September 2002 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Hot Flashes, Prostate Cancer
Keywords
fatigue, recurrent prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, hot flashes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
acupuncture therapy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
fatigue assessment and management
Intervention Description
Patients will utilize the Pittsburgh Sleep Quality Index (PSQI) to assess if the patient is an overall good sleeper or a poor sleeper.
Intervention Type
Procedure
Intervention Name(s)
hot flashes attenuation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Intervention Description
Short Form Health Survey (SF-36) will be used to assess the patient's overall vitality.
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Description
Hot Flash Related Daily Interference Scale (HFRDIS)will be used to self-report hot flash related quality of life.
Primary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
Change in biomarkers at baseline after initiation of study treatment
Time Frame
Baseline after initiation of study treatment.
Title
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.
Title
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.
Title
Change in biomarkers at 4 weeks after initiation of study treatment
Time Frame
4 Weeks after initiation of study treatment.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz M. Beer, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer

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