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OpenTrials
Completed

NCT Number: NCT00268125

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

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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Key information

Conditions

Breast Neoplasms Breast Diseases Nausea Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre Oscar Lambret, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupression's bracelet

Device

Hygiene and dietetic advices

Behavioral

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 22, 2005
Registry last updated
Mar 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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