Phase 3 Study of Acupression's Bracelets in Nausea and Vomiting Induced by FEC100 Chemotherapy's Sort.
Phase 3
Completed
- Conditions
- Breast Neoplasms
- Registration Number
- NCT00268125
- Lead Sponsor
- Institut Claudius Regaud
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 347
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction of 15% of stage III/IV nausea and vomiting's incidence.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Centre Oscar Lambret
🇫🇷Lille, France
Centre Paul STRAUSS
🇫🇷Strasbourg, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Centre Oscar Lambret🇫🇷Lille, France