Clinical trial NCT02840890: Osteopathy and Prevention of Gastrointestinal Side Effects in Women Treated for Breast Cancer
Official title: Osteopathy and Prevention of Gastrointestinal Side Effects of the Adjuvant Treatment FEC in Women Treated in Day Hospital for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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)

Primary outcomes:
measure: episode of nausea and / or vomiting
timeFrame: 3 cycles of chemotherapy (each cycle is 21 days for a total of 63 days)
Secondary outcomes:
measure: episode of constipation
timeFrame: 3 cycles of chemotherapy (each cycle is 21 days for a total of 63 days)
measure: Quality of life questionnaire(QLQ-C30)
timeFrame: 63 days
Other outcomes:
Locations:
city: Dijon
country: France
facility: CGFL
Study officials:
affiliation: Centre Georges François Leclerc
name: Aurélie LAGRANGE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.