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

This study has been completed.
Sponsor:
Information provided by:
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT00268125
First received: December 21, 2005
Last updated: March 17, 2009
Last verified: March 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
 Device: Acupression's bracelet
Behavioral: Hygiene and dietetic advices
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • Reduction of 15% of stage III/IV nausea and vomiting's incidence.

Estimated Enrollment: 347
Study Start Date: February 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268125

Locations
France
Centre Oscar Lambret
Lille, France
Centre Paul STRAUSS
Strasbourg, France
Institut Claudius Regaud
Toulouse, France
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Jean-Pierre DELORD, Dr Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Dr Jean-Pierre DELORD, Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT00268125     History of Changes
Other Study ID Numbers: 05 DIVE 05
Study First Received: December 21, 2005
Last Updated: March 17, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
Breast Neoplasm
FEC100
Chemotherapy
acupression
 bracelet
nausea
vomiting

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Nausea
Vomiting
Neoplasms by Site
 Breast Diseases
Skin Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013