Adapted Fencing in Breast Cancer: a Pilot Study

Breast Neoplasms Clinical Trial

— RIPOSTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04627714
• Other study ID #: 2020-A01916-33
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: November 2022

Study information

• Verified date: January 2022
• Source: Central Hospital, Nancy, France
• Contact: Mathias POUSSEL, MD, PhD
• Phone: 0383155520
• Email: m.poussel[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: November 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• Adapted Physical Activity
Intervention consists in 1h30/week of adapted fencing

Locations

Country	Name	City	State
France	Hia Legouest	Metz
France	CHRU Nancy	Nancy
France	Institut de Cancerologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)