Prostate CancerNCT00421902
Acupuncture Treatment for Hot Flashes Study
A study testing Acupuncture in people with Prostate Cancer, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
Trial summary
Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jun 2012
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment for prostate cancer using hormonal ablation therapy
- Average of three or more hot flashes a day
- Performance Status (Karnofsky ≥ 60)
- Patients must be ≥ 18 years of age
- No other clinically significant disease
- Signed study-specific consent form prior to study entry
Who cannot join
- Initiation of a new chemotherapy regimen, immunotherapy; or initiation/ cessation of hormonal therapy during the study or for 3 weeks before the start of the study
- Pharmacological treatment of hot flashes or use of selective serotonin reuptake inhibitors (unless the dose and patients' condition have been stable for 4 weeks)
- Skin infections
- Patients who had acupuncture treatment in the 6 weeks prior to entering the study, or acupuncture given specifically for the treatment of hot flashes in the previous 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYP- Brooklyn Methodist Hospital
Brooklyn, New York, 11215
About this study
Official title: Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study
Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks
Read the detailed description
Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks. Acupuncture was done according to specific guidelines and mapping.
- Conditions
- Prostate Cancer
- Being tested
- Acupuncture
- Keywords
- Hot flashes, prostate cancer, acupuncture
- Medical subject headings
- Prostatic Neoplasms, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Patients will be have acupuncture (with electro stimulation)
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture of the patients Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief from the hot flashes as determined by the hot flashes scoring system.
A Questionnaire was given to the patients to determine the relief of hot flashes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startJan 2006
- Primary completionJun 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Acupuncture to pevent hot flushes
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hani Ashamalla, MD, New York Presbyterian Brooklyn Methodist Hospital
- Investigators
- Hani Ashamalla, MD, FCCP, Principal investigator, NY Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421902
- Sponsor's protocol ID
- NYM # 325
- Status last verified
- Sep 2020
- First submitted
- 12 Jan 2007
- Last updated
- 18 Sep 2020
- Results posted
- No
Publications
Ashamalla H, Jiang ML, Guirguis A, Peluso F, Ashamalla M. Acupuncture for the alleviation of hot flashes in men treated with androgen ablation therapy. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1358-63. doi: 10.1016/j.ijrobp.2010.01.025. Epub 2010 Jun 3.
PubMed 20605360
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study
- ClinicalTrials.gov ID
- NCT00421902
- Acronym / sponsor ID
- NYM # 325
- Conditions
- Prostate Cancer
- Keywords
- Hot flashes, prostate cancer, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- New York Presbyterian Brooklyn Methodist HospitalUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Jan 2007 (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.
Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks
Detailed description
Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks. Acupuncture was done according to specific guidelines and mapping.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Acupuncture to pevent hot flushes
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureAcupuncture of the patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Treatment for prostate cancer using hormonal ablation therapy
- Average of three or more hot flashes a day
- Performance Status (Karnofsky ≥ 60)
- Patients must be ≥ 18 years of age
- No other clinically significant disease
Key exclusion criteria (4 listed)
- Initiation of a new chemotherapy regimen, immunotherapy; or initiation/ cessation of hormonal therapy during the study or for 3 weeks before the start of the study
- Pharmacological treatment of hot flashes or use of selective serotonin reuptake inhibitors (unless the dose and patients' condition have been stable for 4 weeks)
- Skin infections
- Patients who had acupuncture treatment in the 6 weeks prior to entering the study, or acupuncture given specifically for the treatment of hot flashes in the previous 6 months.
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 |
|---|---|---|
| AcupuncturePatients will be have acupuncture (with electro stimulation) | Procedure or surgery | Acupuncture |
Primary outcome
Relief from the hot flashes as determined by the hot flashes scoring system.
Time frame: 6 months
A Questionnaire was given to the patients to determine the relief of hot flashes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Derived from this study: PubMed 20605360Ashamalla H, Jiang ML, Guirguis A, Peluso F, Ashamalla M. Acupuncture for the alleviation of hot flashes in men treated with androgen ablation therapy. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1358-63. doi: 10.1016/j.ijrobp.2010.01.025. Epub 2010 Jun 3.
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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.
Hani Ashamalla, MD, FCCP principal investigator
NY Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Prostate Cancer, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site 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?
The sponsor lists 6 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relief from the hot flashes as determined by the hot flashes scoring system. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00421902, which also lists 1 linked publication.
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 18 Sep 2020; AzTrials last refreshed its copy on 28 Oct 2026.