Adapted Fencing in Breast Cancer: a Pilot Study

NCT ID: NCT04627714

Last Updated: 2022-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-10

Study Completion Date

2022-11-30

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.

Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Early Fencing

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

Group Type EXPERIMENTAL

Adapted Physical Activity

Intervention Type OTHER

Intervention consists in 1h30/week of adapted fencing

Delayed Fencing

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

Group Type EXPERIMENTAL

Adapted Physical Activity

Intervention Type OTHER

Intervention consists in 1h30/week of adapted fencing

Interventions

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Adapted Physical Activity

Intervention consists in 1h30/week of adapted fencing

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Mathias POUSSEL, MD, PhD

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mathias POUSSEL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Locations

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Hia Legouest

Metz, , France

Site Status RECRUITING

CHRU Nancy

Nancy, , France

Site Status RECRUITING

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mathias POUSSEL, MD, PhD

Role: CONTACT

0383155520 ext. 33

Facility Contacts

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Margaux TEMPERELLI, MD

Role: primary

Mathias POUSSEL, MD

Role: primary

0383175520

cécile Delattre, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35425895 (View on PubMed)

Other Identifiers

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2020-A01916-33

Identifier Type: -

Identifier Source: org_study_id

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