Breast NeoplasmsPhase 3NCT00268125
Phase 3 Study of Acupression's Bracelets in Nausea and Vomiting Induced by FEC100 Chemotherapy's Sort.
A Phase 3 study testing Acupression's bracelet and Hygiene and dietetic advices in people with Breast Neoplasms, run by Institut Claudius Regaud at 3 sites in France.
Trial summary
The purpose of this study is to demonstrate a betterment of the digestive symptomatology by the anti-emetic acupression's bracelets's use associated with hygiene and dietetic advices. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Acupression's bracelet and Hygiene and dietetic advices
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 347 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2006to Dec 2007
- Phase
- Phase 3
- 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
- Woman
- Age > 18 years
- Well-informed written consent, signed by the patient before the beginning of the study
- Breast cancer's diagnosis (operated or not)
- Forecast of a treatment by FEC100 chemotherapy's sort (D1=D21) during at least 3 cycles.
- Patient affiliated at a welfare or beneficiary from it
- Investigator estimates that the patient is able to conform with protocol's conditions and to respect them
Who cannot join
- Operated arm's lymphedema
- Wrist's morphology which cannot permit the bracelet's wearing (20 cm)
- D1=D15 FEC100's treatment
- Psychic incapability to sign a well-informed consent
- Refusal to give a written consent
- Patient under tutelage or guardianship
- Pregnant or breast-feeding woman
- Any clinical trial's participation which would impose nausea and vomiting's treatment modalities
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Oscar Lambret
Lille
Centre Paul STRAUSS
Strasbourg
Institut Claudius Regaud
Toulouse
About this study
Official title: Evaluation of Acupression's Bracelets Associated to an Educational Step Versus Education Only in Nausea and Vomiting's Mastering Induced by FEC100 Chemotherapy's Sort.
The purpose of this study is to demonstrate a betterment of the digestive symptomatology by the anti-emetic acupression's bracelets's use associated with hygiene and dietetic advices.
- Conditions
- Breast Neoplasms
- Being tested
- Acupression's bracelet, Hygiene and dietetic advices
- Keywords
- Breast Neoplasm, FEC100, Chemotherapy, acupression, bracelet, nausea, vomiting
- Medical subject headings
- Breast Neoplasms, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupression's braceletDevice
Hygiene and dietetic advicesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of 15% of stage III/IV nausea and vomiting's incidence.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startFeb 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 347 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Pierre DELORD, Dr, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268125
- Sponsor's protocol ID
- 05 DIVE 05
- Status last verified
- Mar 2009
- First submitted
- 21 Dec 2005
- Last updated
- 18 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acupression's Bracelets Associated to an Educational Step Versus Education Only in Nausea and Vomiting's Mastering Induced by FEC100 Chemotherapy's Sort.
- ClinicalTrials.gov ID
- NCT00268125
- Acronym / sponsor ID
- 05 DIVE 05
- Conditions
- Breast Neoplasms
- Keywords
- Breast Neoplasm, FEC100, Chemotherapy, acupression, bracelet, nausea, vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Dec 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.
The purpose of this study is to demonstrate a betterment of the digestive symptomatology by the anti-emetic acupression's bracelets's use associated with hygiene and dietetic advices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Woman
- Age > 18 years
- Well-informed written consent, signed by the patient before the beginning of the study
- Breast cancer's diagnosis (operated or not)
- Forecast of a treatment by FEC100 chemotherapy's sort (D1=D21) during at least 3 cycles.
Key exclusion criteria (8 listed)
- Operated arm's lymphedema
- Wrist's morphology which cannot permit the bracelet's wearing (20 cm)
- D1=D15 FEC100's treatment
- Psychic incapability to sign a well-informed consent
- Refusal to give a written consent
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 |
|---|---|---|
| Acupression's bracelet | Device | – |
| Hygiene and dietetic advices | Behavioural | – |
Primary outcome
Reduction of 15% of stage III/IV nausea and vomiting's incidence.
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 Mar 2009.
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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.
Jean-Pierre DELORD, Dr principal investigator
Institut Claudius Regaud
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acupression's bracelet and Hygiene and dietetic advices in people with Breast Neoplasms, run by Institut Claudius Regaud at 3 sites in France.
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 7 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 18 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Reduction of 15% of stage III/IV nausea and vomiting's incidence.. 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 18 Mar 2009.