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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05184582




Registration number
NCT05184582
Ethics application status
Date submitted
7/12/2021
Date registered
11/01/2022

Titles & IDs
Public title
Physical Exercise During Preoperative Chemotherapy for Breast Cancer
Scientific title
Physical Exercise During Neoadjuvant Chemotherapy for Breast Cancer as a Means to Increase Pathological Complete Response Rates: the Randomized Neo-ACT Trial
Secondary ID [1] 0 0
Neo-ACT
Universal Trial Number (UTN)
Trial acronym
Neo-ACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Physical training

No intervention: Standard - Routine information on the benefit of physical activity

Experimental: Intervention - High-intensity interval and strength training during neoadjuvant chemotherapy


BEHAVIORAL: Physical training
Participants randomized to the exercise group will complete two structured 60-min exercise sessions per week from initiation of NACT to surgery (approx. five months).
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathological complete response
Timepoint [1] 0 0
5-6 months
Secondary outcome [1] 0 0
Global health-related quality of life
Timepoint [1] 0 0
baseline, after 1 and 2 years
Secondary outcome [2] 0 0
Breast cancer-related quality of life
Timepoint [2] 0 0
baseline, after 1 and 2 years
Secondary outcome [3] 0 0
Self-reported physical activity
Timepoint [3] 0 0
baseline, pre-surgery, 1- and 2-year follow-up
Secondary outcome [4] 0 0
Chemotherapy completion rate
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Cumulative chemotherapy dosage
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
Objective cognitive dysfunction
Timepoint [6] 0 0
baseline and 1 year
Secondary outcome [7] 0 0
Sick leave
Timepoint [7] 0 0
pre-surgery and at 1- and 2-year follow-up
Secondary outcome [8] 0 0
Device-measured physical activity level
Timepoint [8] 0 0
baseline and 5-6months (pre surgery)
Secondary outcome [9] 0 0
Muscle strength
Timepoint [9] 0 0
baseline and 5-6 months
Secondary outcome [10] 0 0
Handgrip strength
Timepoint [10] 0 0
baseline and 5-6 months
Secondary outcome [11] 0 0
Cardiorespiratory fitness
Timepoint [11] 0 0
baseline and 5-6 months (pre-surgery)
Secondary outcome [12] 0 0
Radiological tumour response
Timepoint [12] 0 0
5-6 months
Secondary outcome [13] 0 0
Residual Cancer Burden (RCB)
Timepoint [13] 0 0
5-6 months

Eligibility
Key inclusion criteria
* Patients with primary invasive breast cancer cT1-T3 cN0-2
* Full tumour biology available before initiation of NACT
* Oral and written consent
* Age = 18 years
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy or breast-feeding
* Bilateral invasive breast cancer
* The presence of musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study
* Currently performing equal to or more than 150 mins of moderate to high intensity aerobic exercise and 2 sessions per week of moderate intensity resistance exercise

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
712
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cabrini Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Helsinki
Country [2] 0 0
Finland
State/province [2] 0 0
Turku
Country [3] 0 0
Sweden
State/province [3] 0 0
Gothenburg
Country [4] 0 0
Sweden
State/province [4] 0 0
Lidköping
Country [5] 0 0
Sweden
State/province [5] 0 0
Stockholm
Country [6] 0 0
Sweden
State/province [6] 0 0
Sundsvall
Country [7] 0 0
Sweden
State/province [7] 0 0
Umeå
Country [8] 0 0
Sweden
State/province [8] 0 0
Västerås
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Scotland
Country [10] 0 0
United Kingdom
State/province [10] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Karolinska Institutet
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jana de Boniface
Address 0 0
Karolinska Institutet
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jana de Boniface
Address 0 0
Country 0 0
Phone 0 0
+46702472305
Fax 0 0
Email 0 0
jana.de-boniface@ki.se
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD will be available after study completion upon reasonable request submitted to the PI and with all legal and ethical requirements being fulfilled.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Study protocol, SAP and ICF available on trial homepage presently. Open access. CSR and analytic code available on request, see above.
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://ki.se/en/mmk/the-neo-act-trial


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05184582