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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCentre Paul Strauss

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

No prior chemotherapy treatment

Any known cardiac or vascular pathology

Contraindications to physical fitness assessment

Protected adult

Trial design

Design model

Parallel

Treatments tested in this trial

  • Training sessions

    Procedure/Surgery

    The training program will be performed during 15 weeks, with one session per week.

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Training groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At week 18 (the end of chemotherapy treatment)

Secondary outcomes

1

Physiological variables associated with exercise capacity - cardiorespiratory capacity

To examine the effects of the training program on VO2max.

Time frame
At weeks 8.
2

Physiological variables associated with exercise capacity - cardiorespiratory capacity

To examine the effects of the training program on VO2max.

Time frame
At week 18 (the end of chemotherapy treatment)
3

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.

Time frame
At weeks 8.
4

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.

Time frame
At week 18 (the end of chemotherapy treatment)

Other outcomes

Sponsors and contacts

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