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Trial record 7 of 23 for:    cancer | Studies received from 04/22/2016 to 04/22/2016

Osteopathy and Prevention of Gastrointestinal Side Effects in Women Treated for Breast Cancer (PREDIGOSTEO)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Centre Georges Francois Leclerc
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier:
NCT02840890
First received: April 22, 2016
Last updated: June 20, 2017
Last verified: June 2017
  Purpose

Adjuvant chemotherapy with the protocol 3 cure of 5-FU + Epirubicine + Cyclophosphamide (FEC100) and 3 cure of Taxotere is a standard treatment in the management of patients with breast cancer and in adjuvant situation.

The efficacy of 3 FEC100 and 3 Taxotere protocol in adjuvant situation for women treated for breast cancer is associated with several invalidating side effects for the quality of life of patients. 92% of women treated will present gastrointestinal toxicities of any grade. 11% will present nausea and vomiting of grade 3-4. Current treatments to prevent these gastrointestinal toxicities include Emend from Day 1 to Day 3 in association with setrons at Day 1 and corticosteroids from Day 1 to Day 3. Despite the marked improvement in gastrointestinal toxicities with preventive treatments, 83% of patients would use alternatives medicine: homeopathy, herbal medicine, acupuncture, hypnotherapy and / or osteopathy.

Osteopathy is a method of care and unconventional therapeutic approach. In France, the professional title of osteopath is recognized. It aims to prevent and treat functional disorders, especially those related to adverse effects of treatment. In oncology, this discipline may have additional support for the patient by limiting the mechanical and physical constraints of sensitive areas to the toxicity of the treatment. In the case of gastrointestinal toxicities of myofascial and musculoskeletal techniques are used in abdominal areas to relieve symptoms. The investigators hypothesis is that osteopathy could have an interest in the management of gastrointestinal toxicities related to chemotherapy in women with breast cancer and in adjuvant treatment situation.


Condition Intervention
Breast Cancer Procedure: osteopathic technique Procedure: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Osteopathy and Prevention of Gastrointestinal Side Effects of the Adjuvant Treatment FEC in Women Treated in Day Hospital for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Centre Georges Francois Leclerc:

Primary Outcome Measures:
  • episode of nausea and / or vomiting [ Time Frame: 3 cycles of chemotherapy (each cycle is 21 days for a total of 63 days) ]

Secondary Outcome Measures:
  • episode of constipation [ Time Frame: 3 cycles of chemotherapy (each cycle is 21 days for a total of 63 days) ]
  • Quality of life questionnaire(QLQ-C30) [ Time Frame: 63 days ]

Estimated Enrollment: 94
Actual Study Start Date: November 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental
Patients will have a visceral osteopathic technique perform with continuous pressure on the middle ribs in order to reduce the mechanical stress of the anatomical elements related to liver
Procedure: osteopathic technique
Osteopathe will perform continuous pressure on the middle ribs in order to reduce the mechanical stress of the anatomical elements related to liver
Placebo Comparator: Placebo
patients will have a relaxing osteopathic technique. A non therapeutic abdominal technique
Procedure: Placebo
patients will have a relaxing osteopathic technique. A non therapeutic abdominal technique

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Wife
  • Age over 18 years
  • Operated for a breast cancer stage 1 to 3, in complete resection
  • Plan to receive chemotherapy based on FEC100 3 - 3 TAXOTERE
  • Nurse Consultation prior to chemotherapy
  • planned antiemetic treatment which should include EMEND 125, 80, 80 at J1, J2, J3, ZOPHREN 8 mg IV 1 bulb at J1, Solumedrol 80 mg IV on day 1, Primperan 10 mg 3 tablets a day, from day 1 to day 3, XANAX 0,25 mg 1 tablet morning 1tablet evening from D1 to D3.
  • Distance home CGFL 0 to 50 km, 50 to 100 km, 100 to 200 kms.
  • Having considered the information note
  • written, dated and signed Informed consent

Exclusion Criteria:

  • Man
  • Metastatic breast cancer
  • Breast cancer surgery with incomplete excision
  • Digestive disorders known or known digestive disease
  • Inability to receive one of the basic elements antibiotic treatment
  • Refusal to participate to the trial
  • Persons deprived of liberty or under guardianship
  • Pregnant woman or likely to be
  • Failure to submit to medical testing for geographical reasons (distance home - CGFL more than 200 km), social or psychic
  • non-affiliation to a social security scheme or to the State Medical Aid (AME) or the universal medical coverage (CMU)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02840890

Contacts
Contact: Aurélie LAGRANGE, MD +33 (0)3 80 73 77 18 ALagrange@cgfl.fr

Locations
France
CGFL Recruiting
Dijon, France, 21079
Contact: Emilie REDERSTORFF, PhD    +33 (0)3 80 73 75 00 ext 34 61    ERederstorff@cgfl.fr   
Sponsors and Collaborators
Centre Georges Francois Leclerc
Investigators
Principal Investigator: Aurélie LAGRANGE, MD Centre Georges François Leclerc
  More Information

Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT02840890     History of Changes
Other Study ID Numbers: PREDIGOSTEO
Study First Received: April 22, 2016
Last Updated: June 20, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2017