Breast Neoplasms
Conditions
Keywords
Breast Neoplasm, FEC100, Chemotherapy, acupression, bracelet, nausea, vomiting
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.
Interventions
DEVICEAcupression's bracelet
BEHAVIORALHygiene and dietetic advices
Sponsors
Institut Claudius Regaud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of 15% of stage III/IV nausea and vomiting's incidence. | — |
Countries
France
Outcome results
None listed