Supervised Physical Activity in Young Women With Early Breast Cancer During Neoadjuvant Chemotherpy

NAActive, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 11, 2018

Primary Completion Date

March 31, 2020

Study Completion Date

December 31, 2026

Conditions
Breast Cancer
Interventions
OTHER

High Intensity Interval Training (HIIT)

HIIT training twice a week throughout the chemotherapy: treadmill, elliptical, stationary bicycle and indoor rower. The intensity of physical activity will be increasing during consecutive mesocycles. Each training session will begin with a 10-min. wole-body warm-up session at 50-60% hear rate (HR) max. Mesocycle 1 - one month with 4 sets of 1 min. 45 sec. of exercise at a maximal intensity of 75% HR max. Mesocycle 2 with exercises at 80% to 90% HR max divided into 3 periods: 1/ one month, session of 5 sets 1 min. 30 sec. each; 2/ two months, sessions of 5 sets 1 min. 45 sec. each; 3/ two months, sessions of 5 sets 2 min. each. Moreover patients will be instructed to individually perform- a 45-min. aerobic training session (e.g.: walking, jogging, roller skating, swimming) once a week, in patient's own time.

DRUG

neoadjuvant treatment (doxorubicin, cyclophosphamide, paclitaxel, trastuzumab, pertuzumab)

Patients aged 18 to 40 in good physical condition (Eastern Cooperative Oncology Group (ECOG) scale 0-1) who are set to receive neoadjuvant chemotherapy will be selected. Criteria for entry into the study include proper liver, kidney and bone marrow function as well as heart ejection fraction of ≥ 50%. Treatment will be carried out according to 4 x AC regimen (doxorubicin 60 mg/ m2 cyclophosphamide 600 mg/ m2 i.v. every 21 or every 14 days + pegfilgastrim) followed by 12 x paclitaxel 80 mg/ m2 every 7 days and in the case of HER2 positive tumors trastuzumab ± pertuzumab (according to SPC).

OTHER

Standard Supportive Care

Patients will be asked to perform 150-300 min. of moderate-intensity aerobic activity or 75-150 min. of vigorous aerobic activity. Each participant will be monitored by an activity watch worn at all times by the patient.

Trial Locations (1)

61-866

Ewa Tanska, Poznan

All Listed Sponsors
lead

The Greater Poland Cancer Centre

OTHER

NCT06190600 - Supervised Physical Activity in Young Women With Early Breast Cancer During Neoadjuvant Chemotherpy | Biotech Hunter | Biotech Hunter