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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014