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

January 26, 2022 updated by: Mathias POUSSEL, MD, PhD, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Metz, France
        • Recruiting
        • Hia Legouest
        • Contact:
          • Margaux TEMPERELLI, MD
      • Nancy, France, 54000
      • Vandœuvre-lès-Nancy, France, 54520
        • Recruiting
        • Institut de Cancerologie de Lorraine
        • Contact:
          • Cécile DELATTRE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Other: Adapted Physical Activity
Intervention consists in 1h30/week of adapted fencing
EXPERIMENTAL: 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
Other: Adapted Physical Activity
Intervention consists in 1h30/week of adapted fencing

What is the study measuring?

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.
Time Frame: Baseline (J0) and at 3 months (M3)
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
Time Frame: Baseline (J0) and at 3 months (M3)
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
Time Frame: Baseline (J0) and at 3 months (M3)
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.
Time Frame: Baseline (J0) and at 3 months (M3)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Mathias POUSSEL, MD, PhD, CHRU Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 10, 2021

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

November 1, 2022

Study Registration Dates

First Submitted

November 1, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (ACTUAL)

November 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A01916-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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