Clinical trial NCT04627714: Adapted Fencing in Breast Cancer: a Pilot Study
Official title: Physical and Moral Benefits of Adapted Fencing in Patients With Invasive Breast Cancer: Pilot Study of a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Keywords: Breast
Neoplams
adapted physical activity
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline score of Quality of Life Questionnaire Core 30 (QLQ-C30) at 3 months.
timeFrame: Baseline (J0) and at 3 months (M3)
Secondary outcomes:
measure: Change from baseline score of Disabilities of the Arm, Shoulder and Hand measurement tool (DASH) at 3 months
timeFrame: Baseline (J0) and at 3 months (M3)
measure: Change from baseline score of Multidimensional Fatigue Inventory (MFI-20) at 3 months
timeFrame: Baseline (J0) and at 3 months (M3)
measure: Change from baseline score of Hospital Anxiety and Depression Scale at 3 months.
timeFrame: Baseline (J0) and at 3 months (M3)
Other outcomes:
Locations:
city: Metz
country: France
facility: Hia Legouest
city: Nancy
country: France
facility: CHRU Nancy
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: CHRU Nancy
name: Mathias POUSSEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Omorou AY, Peiffert D, Rotonda C, Van Hoye A, Allado E, Hily O, Temperelli M, Chenuel B, Hornus-Dragne D, Poussel M. Adapted Fencing for Patients With Invasive Breast Cancer: The RIPOSTE Pilot Randomized Controlled Trial. Front Sports Act Living. 2022 Mar 29;4:786852. doi: 10.3389/fspor.2022.786852. eCollection 2022.