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

Breast Neoplasms Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268125
• Other study ID #: 05 DIVE 05
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2005
• Last updated: March 17, 2009
• Start date: February 2006
• Est. completion date: December 2007

Study information

• Verified date: March 2009
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Vomiting

Intervention

Device:
• Acupression's bracelet

Behavioral:
• Hygiene and dietetic advices

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	Centre Paul STRAUSS	Strasbourg
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of 15% of stage III/IV nausea and vomiting's incidence.