Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study

Breast Cancer Clinical Trial

— PROTECT-07  

Official title:

Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455904
• Other study ID #: 2023-005
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: January 13, 2027

Study information

• Verified date: June 2024
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Joris MALLARD, PhD
• Phone: 368767419
• Email: j.mallard[@]icans.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Training sessions
The training program will be performed during 15 weeks, with one session per week.

Locations

Country	Name	City	State
France	Hôpitaux civils de Colmar	Colmar
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

Outcome

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)