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Trial Title:
Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
NCT ID:
NCT06455904
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is an interventional, randomized controlled, prospective, multicenter and adaptive
study aimed at investigating the effect of a concentric pedaling training program carried
out during (neo)adjuvant chemotherapy in addition to usual care.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Training sessions
Description:
The training program will be performed during 15 weeks, with one session per week.
Arm group label:
Training group
Summary:
The association of anthracyclines (ANT) and paclitaxel (Tax) is one of the main
treatments used in breast cancer. These treatments are known to induce severe side
effects such as a decrease in overall exercise capacity (physical condition) in response
to muscle and cardiorespiratory alterations. If exercise may be an effective preventive
strategy, it seems important to prescribe the most efficient exercise modality. Among
them, concentric cycling (i.e., classic cycling) can significantly induce metabolic
stimulus, which is needed for maintaining exercise capacity. The PROTECT-07 study aims to
demonstrate the superiority of a training program based on concentric cycling during
chemotherapy compared to standard treatment. The duration of the training program is 15
weeks with one session per week.
Detailed description:
There will be two groups of patients after drawing lots using a process called
randomization. The probability is one in two of being in the group participating in the
training program, the other group following the standard treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Woman ≥ 18 years old
- Stage I to III breast cancer
- Patient currently planning (neo)adjuvant treatment combining
anthracycline-cyclophosphamide and weekly paclitaxel (± trastuzumab)
- Affiliation to a social security system
- Able to speak, read and understand French
Exclusion Criteria:
- No prior chemotherapy treatment
- Any known cardiac or vascular pathology
- Contraindications to physical fitness assessment
- Protected adult
- Psychiatric, musculoskeletal or neurological problems
- Pregnant or breastfeeding woman (NB: this population is already subject to a
contraindication to (neo)adjuvant treatment. For women of childbearing age, a
betaHCG dosage is already carried out systematically before the start of
chemotherapy and information on the need for contraception throughout the
chemotherapy period is provided before the start of treatment. As part of this
study, only the presence of this test with a negative result at the start of
chemotherapy will be checked. inclusion, if available).
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpitaux civils de Colmar
Address:
City:
Colmar
Zip:
68024
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Manon VOEGELIN
Investigator:
Last name:
Jean-Marc LIMACHER, MD
Email:
Principal Investigator
Facility:
Name:
Institut de cancérologie Strasbourg Europe
Address:
City:
Strasbourg
Zip:
67033
Country:
France
Status:
Recruiting
Contact:
Last name:
Manon VOEGELIN, PhD
Phone:
368339523
Phone ext:
+33
Email:
promotion-rc@icans.eu
Start date:
May 30, 2024
Completion date:
January 13, 2027
Lead sponsor:
Agency:
Institut de cancérologie Strasbourg Europe
Agency class:
Other
Source:
Institut de cancérologie Strasbourg Europe
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06455904
