Breast Cancer Clinical Trial
— PROTECT-07Official title:
Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
NCT number | NCT06455904 |
Other study ID # | 2023-005 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 30, 2024 |
Est. completion date | January 13, 2027 |
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.
Status | Recruiting |
Enrollment | 156 |
Est. completion date | January 13, 2027 |
Est. primary completion date | January 13, 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
France | Hôpitaux civils de Colmar | Colmar | |
France | Institut de cancérologie Strasbourg Europe | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
Institut de cancérologie Strasbourg Europe |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall exercise capacity | To investigate the superiority of a concentric pedaling training program during (neo)adjuvant chemotherapy versus the absence of a training program in patients with early breast cancer. The overall exercise capacity is assessed by the 6-minute walk test (TDM6) between the two groups. | At week 18 (the end of chemotherapy treatment) | |
Secondary | Physiological variables associated with exercise capacity - cardiorespiratory capacity | To examine the effects of the training program on VO2max. | At weeks 8. | |
Secondary | Physiological variables associated with exercise capacity - cardiorespiratory capacity | To examine the effects of the training program on VO2max. | At week 18 (the end of chemotherapy treatment) | |
Secondary | Physiological variables associated with exercise capacity - muscle function | To examine the effects of the training program on maximal aerobic power determined as the lowest exercise intensity inducing a plateauing of O2 consumption during a maximum exercise test. | At weeks 8. | |
Secondary | Physiological variables associated with exercise capacity - muscle function | To examine the effects of the training program on maximal aerobic power determined as the lowest exercise intensity inducing a plateauing of O2 consumption during a maximum exercise test. | At week 18 (the end of chemotherapy treatment) | |
Secondary | Physiological variables associated with exercise capacity - body composition | To examine the effects of the training program on lean mass, fat mass, muscle mass assessed by bioimpedancemetry. | At weeks 8. | |
Secondary | Physiological variables associated with exercise capacity - body composition | To examine the effects of the training program on lean mass, fat mass, muscle mass assessed by bioimpedancemetry. | At week 18 (the end of chemotherapy treatment) | |
Secondary | Physiological variables associated with exercise capacity - muscle architecture | To examine the effects of the training program on muscle thickness assessed by ultrasonography. | At weeks 8. | |
Secondary | Physiological variables associated with exercise capacity - muscle architecture | To examine the effects of the training program on fascicle length assessed by ultrasonography. | At weeks 8. | |
Secondary | Physiological variables associated with exercise capacity - muscle architecture | To examine the effects of the training program on cross-sectional area assessed by ultrasonography. | At weeks 8. | |
Secondary | Physiological variables associated with exercise capacity - muscle architecture | To examine the effects of the training program on muscle thickness assessed by ultrasonography. | At week 18 (the end of chemotherapy treatment) | |
Secondary | Physiological variables associated with exercise capacity - muscle architecture | To examine the effects of the training program on fascicle length assessed by ultrasonography. | At week 18 (the end of chemotherapy treatment) | |
Secondary | Physiological variables associated with exercise capacity - muscle architecture | To examine the effects of the training program on cross-sectional area assessed by ultrasonography. | At week 18 (the end of chemotherapy treatment) | |
Secondary | Psychosocial variables associated with exercise capacity - quality of life | To examine the effects of the training program with the FACT-G questionnaire | At weeks 8. | |
Secondary | Psychosocial variables associated with exercise capacity - quality of life | To examine the effects of the training program with the FACT-G questionnaire | At week 18 (the end of chemotherapy treatment) | |
Secondary | Psychosocial variables associated with exercise capacity - fatigue | To examine the effects of the training program with the FACIT-F questionnaire | At weeks 8. | |
Secondary | Psychosocial variables associated with exercise capacity - fatigue | To examine the effects of the training program with the FACIT-F questionnaire | At week 18 (the end of chemotherapy treatment) | |
Secondary | Psychosocial variables associated with exercise capacity - appetite level | To examine the effects of the training program with the FAACT questionnaire | At weeks 8. | |
Secondary | Psychosocial variables associated with exercise capacity - appetite level | To examine the effects of the training program with the FAACT questionnaire | At week 18 (the end of chemotherapy treatment) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |