Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840890
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Procedure: osteopathic technique Procedure: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
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
Actual Study Start Date : November 5, 2015
Actual Primary Completion Date : November 5, 2015
Actual Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. episode of constipation [ Time Frame: 3 cycles of chemotherapy (each cycle is 21 days for a total of 63 days) ]
  2. Quality of life questionnaire(QLQ-C30) [ Time Frame: 63 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840890


Locations
Layout table for location information
France
CGFL
Dijon, France, 21079
Sponsors and Collaborators
Centre Georges Francois Leclerc
Investigators
Layout table for investigator information
Principal Investigator: Aurélie LAGRANGE, MD Centre Georges François Leclerc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT02840890     History of Changes
Other Study ID Numbers: PREDIGOSTEO
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases