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Completed

NCT Number: NCT02840890

Osteopathy and Prevention of Gastrointestinal Side Effects in Women Treated 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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CGFL

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Placebo

Procedure

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

Primary outcomes

  1. episode of nausea and / or vomiting

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

Secondary outcomes

  1. episode of constipation

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

  2. Quality of life questionnaire(QLQ-C30)

    Time frame: 63 days

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Official study title

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

Acronym: PREDIGOSTEO

Important dates

Study start
2015
Primary completion
2015
Study completion
2018
First posted
Jul 21, 2016
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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