Adapted Fencing in Breast Cancer: a Pilot Study (RIPOSTE)

Central Hospital, Nancy, France

Status: Unknown

Conditions: Breast Neoplasms

Treatments: Other: Adapted Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT04627714

2020-A01916-33

Details and patient eligibility

About

Literature have shown the benefit of practicing regular physical activity during and after cancer treatment, particularly in terms of improving quality of life. The French Fencing Federation has thus developed an adapted physical activity program (Solution RIPOSTE) specially intended for patients with breast cancer. Adapted fencing sessions (saber) are thus offered to these patients in a perfectly secure context (i.e. compulsory medical-sports evaluation and trained fencing master). Since 2016, this RIPOSTE program has been implemented in several fencing halls in Lorraine. Our research project (controlled, randomized trial) aims to assess the impact of the practice of adapted fencing on the quality of life of patients, the functional capacities of the operated side (shoulder) and on the reduction of the sides effects of treatments. Our hypothesis is that such an adapted fencing program improves quality of life as well as functional abilities.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be a woman
• ≥ 18 years old.
• Have undergone unilateral breast surgery for primary invasive breast cancer
• Time between surgery and inclusion between 2 to 4 weeks after surgery
• Accept and be able to complete self-administered questionnaires
• Satisfy the prior medico-sports evaluation
• Be affiliated to a social security scheme or beneficiary of such a scheme
• Have received full information on the organization of the research and have signed their informed consent.

Exclusion criteria

• Presence of bone metastases, especially vertebral
• Presence of a contraindication to the practice of fencing during the medico-sports evaluation (post-surgery period that is too painful and / or requiring specific treatment in rehabilitation)
• Refusal to participate in the study
• Woman of childbearing age who does not have effective contraception.
• Persons referred to Articles L.1121-5, L.1121-7 and L. 1121-8 of the Public Health Code
• Pregnant woman, parturient or nursing mother
• Minor (non-emancipated)
• Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
• Person of full age unable to express consent
• Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Early Fencing

Experimental group

Description:

patients of the "Early Fencing" arm will start adapted fencing practice (1h30/week) within 4 weeks after the breast surgery and for a duration of 3 months

Treatment:

Other: Adapted Physical Activity

Delayed Fencing

Experimental group

Description:

patients of the "Delayed Fencing" arm will start adapted fencing practice (1h30/week) 3 months after the breast surgery and for a duration of 3 months

Treatment:

Other: Adapted Physical Activity