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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.


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Reduction of 15% of stage III/IV nausea and vomiting's incidence.

Principal Investigator

Jean-Pierre DELORD, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

05 DIVE 05

NCT ID:

NCT00268125

Start Date:

February 2006

Completion Date:

December 2007

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasm
  • FEC100
  • Chemotherapy
  • acupression
  • bracelet
  • nausea
  • vomiting
  • Breast Neoplasms
  • Neoplasms
  • Nausea
  • Vomiting

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