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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | patients will have a relaxing osteopathic technique. A non therapeutic abdominal technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| episode of nausea and / or vomiting | 3 cycles of chemotherapy (each cycle is 21 days for a total of 63 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aurélie LAGRANGE, MD | Centre Georges François Leclerc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CGFL | Dijon | 21079 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31430616 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Placebo | Procedure | patients will have a relaxing osteopathic technique. A non therapeutic abdominal technique |
|
| D017437 |
| Skin and Connective Tissue Diseases |