Adapted Fencing in Breast Cancer: a Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Physical and Moral Benefits of Adapted Fencing in Patients With Invasive Breast Cancer: Pilot Study of a Randomized Trial

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Other: Adapted Physical Activity


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Fencing<br>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 | Other: Adapted Physical Activity<br>* Intervention consists in 1h30/week of adapted fencing<br>|
| Experimental: Delayed Fencing<br>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 | Other: Adapted Physical Activity<br>* Intervention consists in 1h30/week of adapted fencing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline score of Disabilities of the Arm, Shoulder and Hand measurement tool (DASH) at 3 months | Questionnaire. 30 items. The score ranges from 0 (no disability) to 100 (most severe disability). | Baseline (J0) and at 3 months (M3) | 
| Change from baseline score of Multidimensional Fatigue Inventory (MFI-20) at 3 months | Questionnaire. 20 items. Minimal value = 20. Maximal value = 100. A high score means a worse outcome (i.e. high level of fatigue) | Baseline (J0) and at 3 months (M3) | 
| Change from baseline score of Hospital Anxiety and Depression Scale at 3 months. | Questionnaire. 14 items. The score ranges from 0 to 100. a high score means a worse outcome (i.e. high level of anxiety and depression) | Baseline (J0) and at 3 months (M3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast, Neoplams, adapted physical activity