Breast NeoplasmsRIPOSTENCT04627714
Adapted Fencing in Breast Cancer: a Pilot Study
A study testing Adapted Physical Activity in people with Breast Neoplasms, run by Central Hospital, Nancy, France at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Adapted Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesFrance
- Study dates
- 10 Nov 2021to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hia Legouest
Metz
Margaux TEMPERELLI, MD
- Recruiting
CHRU Nancy
Nancy, 54000
Mathias POUSSEL, MD, 0383175520, m.poussel@chru-nancy.fr
- Recruiting
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54520
cécile Delattre, MD
About this study
Official title: 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.
- Conditions
- Breast Neoplasms
- Being tested
- Adapted Physical Activity
- Keywords
- Breast, Neoplams, adapted physical activity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical ActivityOther
Intervention consists in 1h30/week of adapted fencing
| Study group | Role | What they receive |
|---|---|---|
| Early Fencing | Experimental | 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 Receives: Other: Adapted Physical Activity |
| Delayed Fencing | Experimental | 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 Receives: Other: Adapted Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline (J0) and at 3 months (M3)
Secondary outcomes (3)
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).
Measured: Baseline (J0) and at 3 months (M3)
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)
Measured: Baseline (J0) and at 3 months (M3)
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)
Measured: Baseline (J0) and at 3 months (M3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start10 Nov 2021
- Primary completionJun 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias POUSSEL, MD, PhD, Central Hospital, Nancy, France
- Investigators
- Mathias POUSSEL, MD, PhD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627714
- Sponsor's protocol ID
- 2020-A01916-33
- Acronym
- RIPOSTE
- Status last verified
- Jan 2022
- First submitted
- 1 Nov 2020
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35425895
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Moral Benefits of Adapted Fencing in Patients With Invasive Breast Cancer: Pilot Study of a Randomized Trial
- ClinicalTrials.gov ID
- NCT04627714
- Acronym / sponsor ID
- RIPOSTE / 2020-A01916-33
- Conditions
- Breast Neoplasms
- Keywords
- Breast, Neoplams, adapted physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Fencing | Experimental | Other: Adapted Physical Activitypatients 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 |
| Delayed Fencing | Experimental | Other: Adapted Physical Activitypatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Physical ActivityIntervention consists in 1h30/week of adapted fencing | Other | Delayed Fencing, Early Fencing |
Primary outcome
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)
3 secondary outcomes
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)
Change from baseline score of Multidimensional Fatigue Inventory (MFI-20) at 3 months
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Derived from this study: PubMed 35425895Omorou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias POUSSEL, MD, PhD principal investigator
CHRU Nancy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity in people with Breast Neoplasms, run by Central Hospital, Nancy, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathias POUSSEL, MD, PhD (0383155520 ext. 33, m.poussel@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04627714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.