Breast CancerNCT00081965
Acupuncture in Treating Hot Flashes in Women With Breast Cancer
A study testing acupuncture therapy, hot flashes attenuation and management of therapy complications in people with Breast Cancer and Hot Flashes, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Acupuncture may help relieve hot flashes in women with breast cancer. It is not yet known whether acupuncture is more effective than a placebo in treating hot flashes in women with breast cancer PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Hot Flashes
- What is being tested?
- acupuncture therapy, hot flashes attenuation and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento May 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer (including in situ disease)
- Must be receiving treatment for breast cancer at Memorial Sloan Kettering Cancer Center (MSKCC) or its regional site (Commack)
- Has an average of 3 or more hot flashes a day during 1 week of baseline diary recording
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Pre- or postmenopausal
- Karnofsky performance status 70-100%
- Ambulatory
- No skin infection
PRIOR CONCURRENT THERAPY:
- More than 3 weeks since prior and no concurrent treatment with any of the following during the 6 week evaluation period of the trial:
- Surgery
- Initiation of a new chemotherapy regimen
- Initiation of immunotherapy
- Initiation of radiotherapy
- Initiation or cessation of hormonal therapy
- More than 6 weeks since prior acupuncture treatment (6 months for acupuncture specifically for the treatment of hot flashes)
- No concurrent pharmacological treatment for hot flashes unless dose has been stable for 4 weeks
- No concurrent selective serotonin reuptake inhibitors (SSRIs) unless dose has been stable for 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial
RATIONALE: Acupuncture may help relieve hot flashes in women with breast cancer. It is not yet known whether acupuncture is more effective than a placebo in treating hot flashes in women with breast cancer
PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in treating hot flashes in women with breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine whether acupuncture, compared to placebo, reduces the incidence of hot flashes in women with breast cancer.
Secondary
- Determine the long-term effects of acupuncture on hot flashes.
OUTLINE: This a randomized, placebo-controlled, multicenter study. Patients are stratified according to concurrent treatment with selective estrogen receptor modulators, gonadotropin-releasing hormone analogs, or aromatase inhibitors (yes vs no), concurrent use of hot flash medication or selective serotonin reuptake inhibitors (SSRIs) (yes vs no), baseline hot flash frequency (> 7 per day), and menopausal status at diagnosis (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.
- Arm I (treatment): Patients receive 8 acupuncture treatments over 4 weeks.
- Arm II (control): Patients receive 8 placebo acupuncture treatments over 4 weeks. Beginning at week 7, patients are offered 8 true acupuncture treatments over 4 weeks.
Patients in both arms complete a "hot flash" diary for 1 week before treatment and then periodically during and after treatment.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
- Conditions
- Breast Cancer, Hot Flashes
- Being tested
- acupuncture therapy, hot flashes attenuation, management of therapy complications
- Keywords
- breast cancer in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IV breast cancer, recurrent breast cancer, stage IIIC breast cancer, hot flashes
- Medical subject headings
- Breast Neoplasms, Hot Flashes, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture therapyProcedure or surgery
hot flashes attenuationProcedure or surgery
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of hot flashes, as measured by a hot flash diary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2004 (estimated)
- Primary completionMay 2007
- Study completionMay 2007
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Randomised
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Barrie R. Cassileth, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081965
- Sponsor's protocol ID
- 02-108
- Other IDs
- MSKCC-02108A
- Status last verified
- Dec 2012
- First submitted
- 27 Apr 2004
- Last updated
- 13 Dec 2012
- Results posted
- No
Publications
Deng G, Vickers A, Yeung S, D'Andrea GM, Xiao H, Heerdt AS, Sugarman S, Troso-Sandoval T, Seidman AD, Hudis CA, Cassileth B. Randomized, controlled trial of acupuncture for the treatment of hot flashes in breast cancer patients. J Clin Oncol. 2007 Dec 10;25(35):5584-90. doi: 10.1200/JCO.2007.12.0774.
PubMed 18065731
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00081965
- Acronym / sponsor ID
- 02-108
- Conditions
- Breast Cancer, Hot Flashes
- Keywords
- breast cancer in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IV breast cancer, recurrent breast cancer, stage IIIC breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 28 Apr 2004 (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 women with breast cancer. It is not yet known whether acupuncture is more effective than a placebo in treating hot flashes in women with breast cancer
PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in treating hot flashes in women with breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine whether acupuncture, compared to placebo, reduces the incidence of hot flashes in women with breast cancer.
Secondary
- Determine the long-term effects of acupuncture on hot flashes.
OUTLINE: This a randomized, placebo-controlled, multicenter study. Patients are stratified according to concurrent treatment with selective estrogen receptor modulators, gonadotropin-releasing hormone analogs, or aromatase inhibitors (yes vs no), concurrent use of hot flash medication or selective serotonin reuptake inhibitors (SSRIs) (yes vs no), baseline hot flash frequency (> 7 per day), and menopausal status at diagnosis (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.
- Arm I (treatment): Patients receive 8 acupuncture treatments over 4 weeks.
- Arm II (control): Patients receive 8 placebo acupuncture treatments over 4 weeks. Beginning at week 7, patients are offered 8 true acupuncture treatments over 4 weeks.
Patients in both arms complete a "hot flash" diary for 1 week before treatment and then periodically during and after treatment.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 therapy | Procedure or surgery | – |
| hot flashes attenuation | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Frequency and severity of hot flashes, as measured by a hot flash diary
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 13 Dec 2012.
- Results publication: PubMed 18065731Deng G, Vickers A, Yeung S, D'Andrea GM, Xiao H, Heerdt AS, Sugarman S, Troso-Sandoval T, Seidman AD, Hudis CA, Cassileth B. Randomized, controlled trial of acupuncture for the treatment of hot flashes in breast cancer patients. J Clin Oncol. 2007 Dec 10;25(35):5584-90. doi: 10.1200/JCO.2007.12.0774.
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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.
Barrie R. Cassileth, PhD principal investigator
Memorial Sloan Kettering Cancer Center
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 therapy, hot flashes attenuation and management of therapy complications in people with Breast Cancer and Hot Flashes, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2012. 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?
Frequency and severity of hot flashes, as measured by a hot flash diary. 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 NCT00081965, 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 13 Dec 2012.