NCT00268125

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

March 18, 2009

Status Verified

March 1, 2009

Enrollment Period

1.8 years

First QC Date

December 21, 2005

Last Update Submit

March 17, 2009

Conditions

Breast Neoplasms

Keywords

Breast NeoplasmFEC100Chemotherapyacupressionbraceletnauseavomiting

Outcome Measures

Primary Outcomes (1)

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

Interventions

Acupression's braceletDEVICE
Hygiene and dietetic advicesBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Oscar Lambret

Lille, France

Location

Centre Paul STRAUSS

Strasbourg, France

Location

Institut Claudius Regaud

Toulouse, France

Location

MeSH Terms

Conditions

Breast NeoplasmsNauseaVomiting

Interventions

Hygiene

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPublic HealthEnvironment and Public Health

Study Officials

  • Jean-Pierre DELORD, Dr

    Institut Claudius Regaud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 22, 2005

Study Start

February 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 18, 2009

Record last verified: 2009-03

Locations

FR(3)