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

October 16, 2023 updated by: Centre Georges Francois Leclerc

Osteopathy and Prevention of Gastrointestinal Side Effects of the Adjuvant Treatment FEC in Women Treated in Day Hospital for Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CGFL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
episode of constipation
Time Frame: 3 cycles of chemotherapy (each cycle is 21 days for a total of 63 days)
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
63 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Investigators

  • Principal Investigator: Aurélie LAGRANGE, MD, Centre Georges Francois Leclerc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2015

Primary Completion (Actual)

November 5, 2015

Study Completion (Actual)

April 20, 2018

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimated)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDIGOSTEO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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