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

• Sponsor: Centre Georges Francois Leclerc (Other)
• Overall Status: Completed
• CT.gov ID: NCT02840890
• Collaborator: (none)
• Enrollment: 94
• Location: 1
• Arms: 2
• Actual Duration (Months): 29.5
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Nov 5, 2015
• Actual Primary Completion Date: Nov 5, 2015
• Actual Study Completion Date: Apr 20, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. episode of nausea and / or vomiting [3 cycles of chemotherapy (each cycle is 21 days for a total of 63 days)]

Secondary Outcome Measures

1. episode of constipation [3 cycles of chemotherapy (each cycle is 21 days for a total of 63 days)]

2. Quality of life questionnaire(QLQ-C30) [63 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CGFL	Dijon		France	21079

Sponsors and Collaborators

• Centre Georges Francois Leclerc

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Georges Francois Leclerc
• ClinicalTrials.gov Identifier: NCT02840890
• Other Study ID Numbers: PREDIGOSTEO
• First Posted: Jul 21, 2016
• Last Update Posted: Mar 15, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Mar 15, 2019