Adapted Fencing in Breast Cancer: a Pilot Study
RIPOSTE
Physical and Moral Benefits of Adapted Fencing in Patients With Invasive Breast Cancer: Pilot Study of a Randomized Trial
1 other identifier
interventional
24
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2021
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedStudy Start
First participant enrolled
November 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedJanuary 27, 2022
January 1, 2022
7 months
November 1, 2020
January 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline score of Quality of Life Questionnaire Core 30 (QLQ-C30) at 3 months.
Questionnaire. 30 items. minimum value = 30. Maximum value = 120. A high score means a worse outcome (i.e. poor quality of life)
Baseline (J0) and at 3 months (M3)
Secondary Outcomes (3)
Change from baseline score of Disabilities of the Arm, Shoulder and Hand measurement tool (DASH) at 3 months
Baseline (J0) and at 3 months (M3)
Change from baseline score of Multidimensional Fatigue Inventory (MFI-20) at 3 months
Baseline (J0) and at 3 months (M3)
Change from baseline score of Hospital Anxiety and Depression Scale at 3 months.
Baseline (J0) and at 3 months (M3)
Study Arms (2)
Early Fencing
EXPERIMENTALpatients 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
Delayed Fencing
EXPERIMENTALpatients 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
Interventions
Intervention consists in 1h30/week of adapted fencing
Eligibility Criteria
You may qualify if:
- Be a woman
- ≥ 18 years old.
- Have undergone unilateral breast surgery for primary invasive breast cancer
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hia Legouest
Metz, France
CHRU Nancy
Nancy, 54000, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54520, France
Related Publications (1)
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.
PMID: 35425895DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mathias POUSSEL, MD, PhD
CHRU Nancy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
November 1, 2020
First Posted
November 13, 2020
Study Start
November 10, 2021
Primary Completion
June 1, 2022
Study Completion
November 1, 2022
Last Updated
January 27, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share