Phase 3 Study of Acupression's Bracelets in Nausea and Vomiting Induced by FEC100 Chemotherapy's Sort.

Institut Claudius Regaud

Status and phase

Completed

Phase 3

Conditions

Breast Neoplasms

Treatments

Behavioral: Hygiene and dietetic advices

Device: Acupression's bracelet

Study type

Interventional

Funder types

Other

Identifiers

NCT00268125

05 DIVE 05

Details and patient eligibility

About

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.

Enrollment

347 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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