Status:
COMPLETED
Phase 3 Study of Acupression's Bracelets in Nausea and Vomiting Induced by FEC100 Chemotherapy's Sort.
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT00268125
Start Date
February 1 2006
End Date
December 1 2007
Last Update
March 18 2009
Active Locations (3)
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1
Centre Oscar Lambret
Lille, France
2
Centre Paul STRAUSS
Strasbourg, France
3
Institut Claudius Regaud
Toulouse, France