Ovarian NeoplasmsPhase 1NCT00090389
Acupuncture for Women's Health Conditions
A Phase 1 study testing Chinese Acupuncture in people with Ovarian Neoplasms and Endometriosis, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of acupuncture in treating women's health conditions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Endometriosis, Pelvic Pain
- What is being tested?
- Chinese Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to May 2007
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed ovarian cancer; primary peritoneal cancer; papillary serous cancer of the endometrium; or mixed mesodermal tumor of the uterus, ovary, or fallopian tube
- Currently undergoing chemotherapy
- Meet certain laboratory test requirements
- Currently closed to recruitment
- Diagnosed with endometriosis or unspecified pelvic pain
Who cannot join
- Use of white blood cell boosters
- Prior radiotherapy with the exception of whole-breast irradiation for breast cancer
- Prior myelotoxic chemotherapy
- History of symptomatic cardiac or psychiatric disorder
- Use of a pacemaker
- Use of herbs or herbal supplements
- Prior use of acupuncture
- Enrollment in other research studies
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: New England School of Acupuncture (NESA) Acupuncture Research Collaborative
The purpose of this study is to evaluate the safety and effectiveness of acupuncture in treating women's health conditions.
Read the detailed description
This trial comprises three studies. In the first two studies, women will be randomly assigned to receive either real or sham acupuncture therapy. Study 1 will include women with various forms of cancer. White blood cell counts will be used to assess the effects of acupuncture on participants' immune responses. Study 2 will include women with unspecified pelvic pain and endometriosis; a self-report pain scale will be used to assess the effects of acupuncture on participants' symptoms. Study 3 will evaluate the validity and reliability of diagnoses made by Chinese medicine practitioners. In this study, a group of Chinese medicine practitioners will diagnose the same group of patients; consistency of the diagnoses will be evaluated.
- Conditions
- Ovarian Neoplasms, Endometriosis, Pelvic Pain, Uterine Neoplasms
- Being tested
- Chinese Acupuncture
- Keywords
- Acupuncture, Medicine, Chinese Traditional
- Medical subject headings
- Ovarian Neoplasms, Endometriosis, Pelvic Pain, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese AcupunctureProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2004 (estimated)
- Study startJan 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Peter Wayne, PhD, Principal investigator, New England School of Acupuncture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090389
- Sponsor's protocol ID
- U19AT002022
- Status last verified
- Jan 2008
- First submitted
- 25 Aug 2004
- Last updated
- 25 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New England School of Acupuncture (NESA) Acupuncture Research Collaborative
- ClinicalTrials.gov ID
- NCT00090389
- Acronym / sponsor ID
- U19AT002022
- Conditions
- Ovarian Neoplasms, Endometriosis, Pelvic Pain, Uterine Neoplasms
- Keywords
- Acupuncture, Medicine, Chinese Traditional
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Jan 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 26 Aug 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.
The purpose of this study is to evaluate the safety and effectiveness of acupuncture in treating women's health conditions.
Detailed description
This trial comprises three studies. In the first two studies, women will be randomly assigned to receive either real or sham acupuncture therapy. Study 1 will include women with various forms of cancer. White blood cell counts will be used to assess the effects of acupuncture on participants' immune responses. Study 2 will include women with unspecified pelvic pain and endometriosis; a self-report pain scale will be used to assess the effects of acupuncture on participants' symptoms. Study 3 will evaluate the validity and reliability of diagnoses made by Chinese medicine practitioners. In this study, a group of Chinese medicine practitioners will diagnose the same group of patients; consistency of the diagnoses will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed ovarian cancer; primary peritoneal cancer; papillary serous cancer of the endometrium; or mixed mesodermal tumor of the uterus, ovary, or fallopian tube
- Currently undergoing chemotherapy
- Meet certain laboratory test requirements
- Currently closed to recruitment
- Diagnosed with endometriosis or unspecified pelvic pain
Key exclusion criteria (8 listed)
- Use of white blood cell boosters
- Prior radiotherapy with the exception of whole-breast irradiation for breast cancer
- Prior myelotoxic chemotherapy
- History of symptomatic cardiac or psychiatric disorder
- Use of a pacemaker
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 |
|---|---|---|
| Chinese Acupuncture | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 25 Jan 2008.
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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.
Peter Wayne, PhD principal investigator
New England School of Acupuncture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chinese Acupuncture in people with Ovarian Neoplasms and Endometriosis, run by National Center for Complementary and Integrative Health (NCCIH) 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 5 inclusion and 8 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 25 Jan 2008. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 25 Jan 2008.