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

Primary Purpose

Breast Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adapted Physical Activity
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms focused on measuring Breast, Neoplams, adapted physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hia LegouestRecruiting
  • CHRU NancyRecruiting
  • Institut de Cancerologie de LorraineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early Fencing

Delayed Fencing

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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)
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)

Full Information

First Posted
November 1, 2020
Last Updated
January 26, 2022
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT04627714
Brief Title
Adapted Fencing in Breast Cancer: a Pilot Study
Acronym
RIPOSTE
Official Title
Physical and Moral Benefits of Adapted Fencing in Patients With Invasive Breast Cancer: Pilot Study of a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Breast, Neoplams, adapted physical activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Fencing
Arm Type
Experimental
Arm Description
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
Arm Title
Delayed Fencing
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Adapted Physical Activity
Intervention Description
Intervention consists in 1h30/week of adapted fencing
Primary Outcome Measure Information:
Title
Change from baseline score of Quality of Life Questionnaire Core 30 (QLQ-C30) at 3 months.
Description
Questionnaire. 30 items. minimum value = 30. Maximum value = 120. A high score means a worse outcome (i.e. poor quality of life)
Time Frame
Baseline (J0) and at 3 months (M3)
Secondary Outcome Measure Information:
Title
Change from baseline score of Disabilities of the Arm, Shoulder and Hand measurement tool (DASH) at 3 months
Description
Questionnaire. 30 items. The score ranges from 0 (no disability) to 100 (most severe disability).
Time Frame
Baseline (J0) and at 3 months (M3)
Title
Change from baseline score of Multidimensional Fatigue Inventory (MFI-20) at 3 months
Description
Questionnaire. 20 items. Minimal value = 20. Maximal value = 100. A high score means a worse outcome (i.e. high level of fatigue)
Time Frame
Baseline (J0) and at 3 months (M3)
Title
Change from baseline score of Hospital Anxiety and Depression Scale at 3 months.
Description
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)
Time Frame
Baseline (J0) and at 3 months (M3)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathias POUSSEL, MD, PhD
Phone
0383155520
Ext
33
Email
m.poussel@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias POUSSEL, MD, PhD
Organizational Affiliation
CHRU Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hia Legouest
City
Metz
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaux TEMPERELLI, MD
Facility Name
CHRU Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathias POUSSEL, MD
Phone
0383175520
Email
m.poussel@chru-nancy.fr
Facility Name
Institut de Cancerologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54520
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
cécile Delattre, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35425895
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.
Results Reference
derived

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Adapted Fencing in Breast Cancer: a Pilot Study

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