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

This study is currently recruiting participants.

Verified by Institut Claudius Regaud, November 2006

Sponsored by:	Institut Claudius Regaud
Information provided by:	Institut Claudius Regaud
ClinicalTrials.gov Identifier:	NCT00268125

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 III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

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
Estimated Study Completion Date:	December 2008

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

Contacts

Contact: Jean-Pierre DELORD, Dr

+33 5 61 42 40 79

delord_j@icr.fnclcc.fr

Locations

France
Centre Paul STRAUSS	Recruiting
STRASBOURG, France
Contact: Thierry PETIT, Dr +33 3.88.25.24.24 tpetit@strasbourg.fnclcc.fr
Centre Oscar Lambret	Not yet recruiting
LILLE, France
Contact: Nicolas PENEL, Dr +33 3.20.29.59.20 n-penel@o-lambret.fr
Institut Claudius Regaud	Recruiting
TOULOUSE, France
Contact: Jean-Pierre DELORD, Dr +33.5.61.42.40.79 Delord.Jean-Pierre@claudiusregaud.fr

Sponsors and Collaborators

Institut Claudius Regaud

Investigators

Principal Investigator:

Jean-Pierre DELORD, Dr

Institut Claudius Regaud

More Information

Study ID Numbers:	05 DIVE 05
Study First Received:	December 21, 2005
Last Updated:	November 10, 2006
ClinicalTrials.gov Identifier:	NCT00268125
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Claudius Regaud:

Breast Neoplasm
FEC100
Chemotherapy
acupression

bracelet
nausea
vomiting

Study placed in the following topic categories:

Vomiting
Skin Diseases
Breast Neoplasms
Nausea
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009