Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology (OSTEOPATHIE)

This study is currently recruiting participants.
Verified January 2014 by Centre Leon Berard
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01403168
First received: July 21, 2011
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

This is an open, prospective, controlled, randomized, comparative study with 2 arms.

The purpose of the study is to assess the efficacy of osteopathy after breast surgery.

80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will be followed during one year.


Condition Intervention
Breast Cancer
Other: OSTEOPATHY + conventional analgesic treatments
Other: Conventional analgesic treatments

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Efficacy of the osteopathy treatment on pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Pain is assessed by means of visual analogic scale (from 0 to 10 points). A decrease of 2 points after 3 months is expected.


Estimated Enrollment: 80
Study Start Date: April 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: osteopathy + conventional analgesic treatments Other: OSTEOPATHY + conventional analgesic treatments

5 sessions for osteopathy are planned and will start in the 15 days following the enrollment.

The conventional analgesic treatments will be administered in the 15 days following the enrollment.

Placebo Comparator: conventional analgesic treatments Other: Conventional analgesic treatments
These treatments will be administered in the 15 days following the enrollment. Dose and frequence will depend on patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • woman >= 18 years
  • pain (median VAS >=3 on the week prior to inclusion)
  • mastectomy or tumorectomy with axillary dissection <= 12 months
  • PS <=2
  • able to write, understand and read French
  • signed informed consent

Exclusion Criteria:

  • no pain
  • immediate breast reconstruction
  • history of cognitive or psychiatric troubles
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403168

Contacts
Contact: Ellen BLANC +33 4 78 78 29 67 ellen.blanc@lyon.unicancer.fr
Contact: Valérie BOURNE-BRANCHU +33 4 78 78 26 58 valerie.bourne-branchu@lyon.unicancer.fr

Locations
France
Centre Leon Berard Recruiting
LYON Cedex 08, France, 69373
Contact: Ellen BLANC    +33 4 78 78 29 67    ellen.blanc@lyon.unicancer.fr   
Principal Investigator: Gisèle CHVETZOFF, MD         
Sub-Investigator: Véronique TEQUI, MD         
Sub-Investigator: Véronique PERES-BACHELOT, MD         
Sub-Investigator: Christelle FAURE, MD         
Sub-Investigator: Hervé MIGNOTTE, MD         
Sponsors and Collaborators
Centre Leon Berard
Investigators
Principal Investigator: Gisele CHVETZOFF, MD Centre Leon Berard
  More Information

Publications:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01403168     History of Changes
Other Study ID Numbers: OSTEOPATHIE
Study First Received: July 21, 2011
Last Updated: January 30, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: French Data Protection Authority

Keywords provided by Centre Leon Berard:
Osteopathy
Breast cancer
Pain

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014