RIPOSTE: Adapted Fencing in Breast Cancer: a Pilot Study

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT04627714

Collaborator

(none)

Enrollment

Locations

Arms

11.7

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Other: Adapted Physical Activity	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 10, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline score of Quality of Life Questionnaire Core 30 (QLQ-C30) at 3 months. [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)

Secondary Outcome Measures

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)]
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 [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)
Change from baseline score of Hospital Anxiety and Depression Scale at 3 months. [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hia Legouest	Metz	France
2	CHRU Nancy	Nancy	France	54000
3	Institut de Cancerologie de Lorraine	Vandœuvre-lès-Nancy	France	54520

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mathias POUSSEL, MD, PhD, Clinical Professor, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT04627714

Other Study ID Numbers:

2020-A01916-33

First Posted:

Nov 13, 2020

Last Update Posted:

Jan 27, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mathias POUSSEL, MD, PhD, Clinical Professor, Central Hospital, Nancy, France

Breast

Neoplams

adapted physical activity

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Jan 27, 2022