FatigueNCT00244894
Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer
A study testing acupuncture therapy, fatigue assessment and management and hot flashes attenuation in people with Fatigue and Hot Flashes, run by OHSU Knight Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Fatigue, Hot Flashes, Prostate Cancer
- What is being tested?
- acupuncture therapy, fatigue assessment and management and hot flashes attenuation
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2002to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
2 sites in 1 country.
United States2 sites
OHSU Knight Cancer Institute
Portland, Oregon, 97239-3098
Portland VA Medical Center
Portland, Oregon, 97239
About this study
Official title: Acupuncture for Hot Flashes in Prostate Cancer Patients
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.
Read the 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.
- Conditions
- Fatigue, Hot Flashes, Prostate Cancer
- Being tested
- acupuncture therapy, fatigue assessment and management, hot flashes attenuation, management of therapy complications, quality-of-life assessment
- Keywords
- fatigue, recurrent prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, hot flashes
- Medical subject headings
- Fatigue, Hot Flashes, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture therapyProcedure or surgery
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
fatigue assessment and managementProcedure or surgery
Patients will utilize the Pittsburgh Sleep Quality Index (PSQI) to assess if the patient is an overall good sleeper or a poor sleeper.
hot flashes attenuationProcedure or surgery
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.
management of therapy complicationsProcedure or surgery
Short Form Health Survey (SF-36) will be used to assess the patient's overall vitality.
quality-of-life assessmentProcedure or surgery
Hot Flash Related Daily Interference Scale (HFRDIS)will be used to self-report hot flash related quality of life.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced hot flash frequency and intensity as measured by hot flash score from hot flash diary at 4 weeks after initiation of study treatment
Measured: 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
Measured: 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
Measured: 16 Weeks after initiation of study treatment.
Secondary outcomes (5)
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
Measured: 4 Weeks after initiation of study treatment.
Change in biomarkers at baseline after initiation of study treatment
Measured: 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
Measured: 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
Measured: 16 Weeks after intiation of study treatment.
Change in biomarkers at 4 weeks after initiation of study treatment
Measured: 4 Weeks after initiation of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startSep 2002
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Tom Beer, OHSU Knight Cancer Institute
- Investigators
- Tomasz M. Beer, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244894
- Sponsor's protocol ID
- CDR0000445180
- Other IDs
- OHSU-7235, OHSU-HOR-02029-LX
- Status last verified
- Apr 2017
- First submitted
- 25 Oct 2005
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Hot Flashes in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT00244894
- Acronym / sponsor ID
- CDR0000445180
- Conditions
- Fatigue, Hot Flashes, Prostate Cancer
- Keywords
- fatigue, recurrent prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer, hot flashes
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2002
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 27 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture therapyAcupuncture 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 or surgery | – |
| fatigue assessment and managementPatients will utilize the Pittsburgh Sleep Quality Index (PSQI) to assess if the patient is an overall good sleeper or a poor sleeper. | Procedure or surgery | – |
| hot flashes attenuationPatients 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 or surgery | – |
| management of therapy complicationsShort Form Health Survey (SF-36) will be used to assess the patient's overall vitality. | Procedure or surgery | – |
| quality-of-life assessmentHot Flash Related Daily Interference Scale (HFRDIS)will be used to self-report hot flash related quality of life. | Procedure or surgery | – |
Primary outcome
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.
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.
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.
5 secondary outcomes
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.
Change in biomarkers at baseline after initiation of study treatment
Time frame: 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.
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.
Change in biomarkers at 4 weeks after initiation of study treatment
Time frame: 4 Weeks after initiation of study treatment.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz M. Beer, MD principal investigator
OHSU Knight Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture therapy, fatigue assessment and management and hot flashes attenuation in people with Fatigue and Hot Flashes, run by OHSU Knight Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: Weeks 4 after initiation of study treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.