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

NCT02840890 | Completed

• 1 other identifier: PREDIGOSTEO
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• episode of nausea and / or vomiting

  3 cycles of chemotherapy (each cycle is 21 days for a total of 63 days)

Secondary Outcomes (2)

• episode of constipation

  3 cycles of chemotherapy (each cycle is 21 days for a total of 63 days)

• Quality of life questionnaire(QLQ-C30)

  63 days

Study Arms (2)

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

Placebo

PLACEBO COMPARATOR

patients will have a relaxing osteopathic technique. A non therapeutic abdominal technique

Procedure: Placebo

Interventions

osteopathic technique PROCEDURE

Osteopathe will perform continuous pressure on the middle ribs in order to reduce the mechanical stress of the anatomical elements related to liver

experimental

Placebo PROCEDURE

patients will have a relaxing osteopathic technique. A non therapeutic abdominal technique

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

CGFL

Dijon, 21079, France

Location

Related Publications (1)

• Lagrange A, Decoux D, Briot N, Hennequin A, Coudert B, Desmoulins I, Bertaut A. Visceral osteopathic manipulative treatment reduces patient reported digestive toxicities induced by adjuvant chemotherapy in breast cancer: A randomized controlled clinical study. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:49-55. doi: 10.1016/j.ejogrb.2019.08.003. Epub 2019 Aug 12.

  PMID: 31430616 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aurélie LAGRANGE, MD

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: July 21, 2016
• Study Start: November 5, 2015
• Primary Completion: November 5, 2015
• Study Completion: April 20, 2018
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)