Neo-train: Pre-operative Exercise During Neoadjuvant Chemotherapy in Patients With Breast Cancer - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Zealand University Hospital
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Tumour size
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Due to the nature of the intervention, it is not possible to blind the participants, care providers or investigators. However, the outcome assessors of the primary endpoint (MRI assessment) will not be informed of the patients' allocation. Further, the statistician and data manager are blinded as the group allocation will be coded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention arm
Prehabilitation program
Intervention: Prehabilitation program (Behavioral)
Control arm
Usual care
Outcomes
Primary Outcomes
Tumour size
Time Frame: Sequential MRI scans follow the individual treatment plan in a period of up to 30 weeks from baseline (diagnostic MRI before start of neoadjuvant chemotherapy) to MRI performed by the end of the course of neoadjuvant chemotherapy before breast surgery.
Change in the maximum diameter of the tumour visualized by magnetic resonance imaging (MRI).
Secondary Outcomes
- Changes in total body mass(Baseline, during the week before breast surgery, 3 months after breast surgery)
- Changes in fat mass(Baseline, during the week before breast surgery, 3 months after breast surgery)
- Pathological response grade(At time of breast surgery estimated to take place within 30 weeks from baseline)
- Number of participants with early discontinuation of neoadjuvant chemotherapy(Baseline to time of breast surgery estimated up to 30 weeks)
- Changes in muscle strength(Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery)
- Relative dose intensity of neoadjuvant chemotherapy(Baseline to time of breast surgery estimated up to 30 weeks)
- Number of participants with neoadjuvant chemotherapy dose reductions(Baseline to time of breast surgery estimated up to 30 weeks)
- Number of participants with neoadjuvant chemotherapy dose delays(Baseline to time of breast surgery estimated up to 30 weeks)
- Total length of hospital admissions during neoadjuvant chemotherapy(Baseline to time of breast surgery estimated up to 30 weeks)
- Changes in physical fitness(Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery)
- Number of hospital admissions during neoadjuvant chemotherapy(Baseline to time of breast surgery estimated up to 30 weeks)
- Tumour infiltrating lymphocyte population(Baseline (pre-chemotherapy) to time of breast surgery estimated up to 30 weeks)
- Liquid biopsies(Baseline, approximately week 7, 13 and 19, 3 months after breast surgery)
- Cytokines(Baseline, approximately week 13 and 19, 3 months after breast surgery)
- Changes in lean body mass(Baseline, during the week before breast surgery, 3 months after breast surgery)
- Changes in physical function(Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery)
- Post-operative referral to and participation in municipal rehabilitation programs(Breast surgery to 3 months after breast surgery)
- Metabolic and inflammatory markers(Baseline, approximately week 13 and 19, 3 months after breast surgery)
- Cell proliferation(Approximately between week 1-4 during neoadjuvant chemotherapy and within 6 weeks before breast surgery)
- Changes in level of physical activity(Baseline, during the week before breast surgery, 3 months after breast surgery)
- Changes in health-related quality of life(Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery)
- Changes in general anxiety(Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery)
- Changes in depression(Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery)
- Tumour size(At time of breast surgery estimated to take place within 30 weeks from baseline)
- Tumour vascularity(Baseline (pre-chemotherapy) to time of breast surgery estimated up to 30 weeks)
- Survival(Breast surgery to up to 10 years follow-up after breast surgery)
- Changes in psychological distress(Baseline, week 13 during neoadjuvant chemotherapy, during the week before breast surgery, 3 months after breast surgery)
- Recurrence(Breast surgery to up to 10 years follow-up after breast surgery)
- Tumour size(Sequential clinical examinations of the breast following the individual treatment plan in a period of up to 30 weeks from baseline to time of breast surgery)
Investigators
Susanne Dalton
Professor
Zealand University Hospital