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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Acupression's bracelet

Intervention Type DEVICE

Hygiene and dietetic advices

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No