Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer (Neo-train)

Zealand University Hospital

Status

Active, not recruiting

Conditions

Breast Cancer

Treatments

Behavioral: Prehabilitation program

Study type

Interventional

Funder types

Other

Identifiers

NCT04623554

REG-074-2020

Details and patient eligibility

About

The Neo-Train study is a randomized controlled trial investigating the effects of supervised pre-operative aerobic and resistance exercise in patients with breast cancer during neoadjuvant chemotherapy.

Full description

The long neoadjuvant chemotherapy period in patients with breast cancer brings a time window of opportunity to investigate the potential of pre-operative exercise to increase treatment efficacy with improved tumour regression. A possible improvement in chemotherapy completion, lift in physical function, alleviated toxicities as well as changes in biological markers can also be investigated.

120 patients with newly diagnosed breast cancer who start neoadjuvant chemotherapy will be randomized to the intervention arm (n=60) and control arm (n=60).

Participants in the intervention arm will be prescribed a prehabilitation program consisting of thrice weekly combined supervised aerobic and resistance exercise during the neoadjuvant chemotherapy period. Participants will be screened for psychological distress four times and in case of moderate-severe distress be advised to visit the local Cancer Society Support Center where participants will be assessed and offered free services based on their psychosocial needs and available offers.

Participants in the control arm will receive usual care.

Outcomes will be measured at baseline (diagnosis), during neoadjuvant chemotherapy, during the week before breast surgery, at breast surgery and at 3 months follow up.

The participants will receive the recommended neoadjuvant chemotherapy regimens in Denmark - currently up to 24 weeks. With expected chemotherapy dose delays, the time of breast surgery is expected to be within 30 weeks from baseline. The treatment plans will be individually modified based on tumour response and expected side effects to treatment. A subgroup of participants may change neoadjuvant chemotherapy regimen and be referred to breast surgery early. In these participants, the last measurement during chemotherapy will be used, and the 3 months follow up measurement will still be scheduled at 3 months after breast surgery.

The study procedures will be pre-tested in a pilot study with 6 patients who will all receive the prehabilitation program.

Enrollment

102 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients newly diagnosed with histologically verified breast cancer and scheduled for neoadjuvant chemotherapy
Female gender
Aged ≥ 18 years old
Signed informed consent

Exclusion criteria

Patients ineligible for or who have declined to receive neoadjuvant chemotherapy
Contraindications to magnetic resonance imaging (MRI)
Physical or cognitive disabilities preventing exercise or physical testing
Inability to read and understand Danish
Based on clinical judgement, the physician assesses that the patient is not suitable for inclusion