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

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Acupression's bracelet
Hygiene and dietetic advices
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Neoplasms focused on measuring Breast Neoplasm, FEC100, Chemotherapy, acupression, bracelet, nausea, vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Oscar Lambret
  • Centre Paul STRAUSS
  • Institut Claudius Regaud

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 21, 2005
Last Updated
March 17, 2009
Sponsor
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT00268125
Brief Title
Phase 3 Study of Acupression's Bracelets in Nausea and Vomiting Induced by FEC100 Chemotherapy's Sort.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Institut Claudius Regaud

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Breast Neoplasm, FEC100, Chemotherapy, acupression, bracelet, nausea, vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
347 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Acupression's bracelet
Intervention Type
Behavioral
Intervention Name(s)
Hygiene and dietetic advices
Primary Outcome Measure Information:
Title
Reduction of 15% of stage III/IV nausea and vomiting's incidence.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre DELORD, Dr
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
Centre Paul STRAUSS
City
Strasbourg
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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