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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
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Scientific title
Physical Exercise During Neoadjuvant Chemotherapy for Breast Cancer as a Means to Increase Pathological Complete Response Rates: the Randomized Neo-ACT Trial
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Secondary ID [1]
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Neo-ACT
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Universal Trial Number (UTN)
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Trial acronym
Neo-ACT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pathological complete response
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Assessment method [1]
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Absence of residual invasive tumor in breast and axilla at surgery
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Timepoint [1]
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5-6 months
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Secondary outcome [1]
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Global health-related quality of life
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Assessment method [1]
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assessed by the EORTC QLQ-C30 questionnaire
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Timepoint [1]
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baseline, after 1 and 2 years
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Secondary outcome [2]
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Breast cancer-related quality of life
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Assessment method [2]
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assessed by the EORTC QLQ-B23 questionnaire
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Timepoint [2]
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baseline, after 1 and 2 years
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Secondary outcome [3]
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Self-reported physical activity
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Assessment method [3]
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Modified Godin Leisure Time Physical activity questionnaire
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Timepoint [3]
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baseline, pre-surgery, 1- and 2-year follow-up
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Secondary outcome [4]
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Chemotherapy completion rate
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Assessment method [4]
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proportion of participants receiving the planned number of treatments
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Timepoint [4]
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1 year
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Secondary outcome [5]
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Cumulative chemotherapy dosage
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Assessment method [5]
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total dose of NACT received to account for potential dose reduction
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Timepoint [5]
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1 year
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Secondary outcome [6]
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Objective cognitive dysfunction
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Assessment method [6]
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online neuropsychological test (Amsterdam Cognition Scan)
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Timepoint [6]
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baseline and 1 year
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Secondary outcome [7]
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Sick leave
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Assessment method [7]
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Patient-reported absence from work
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Timepoint [7]
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pre-surgery and at 1- and 2-year follow-up
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Secondary outcome [8]
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Device-measured physical activity level
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Assessment method [8]
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Fit-bit tracker
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Timepoint [8]
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baseline and 5-6months (pre surgery)
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Secondary outcome [9]
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Muscle strength
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Assessment method [9]
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hypothetical 1-RM maximal leg muscle strength test
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Timepoint [9]
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baseline and 5-6 months
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Secondary outcome [10]
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Handgrip strength
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Assessment method [10]
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handgrip strength test
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Timepoint [10]
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baseline and 5-6 months
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Secondary outcome [11]
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Cardiorespiratory fitness
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Assessment method [11]
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Åstrand submaximal cycle test
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Timepoint [11]
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baseline and 5-6 months (pre-surgery)
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Secondary outcome [12]
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Radiological tumour response
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Assessment method [12]
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RECIST
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Timepoint [12]
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5-6 months
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Secondary outcome [13]
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Residual Cancer Burden (RCB)
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Assessment method [13]
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Degree of tumor response to NACT
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Timepoint [13]
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5-6 months
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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
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/11/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2027
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Actual
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Sample size
Target
712
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Cabrini Health - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Finland
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State/province [1]
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Helsinki
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Country [2]
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Finland
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State/province [2]
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Turku
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Country [3]
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Sweden
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State/province [3]
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Gothenburg
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Country [4]
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Sweden
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State/province [4]
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Lidköping
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Country [5]
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Sweden
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State/province [5]
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Stockholm
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Country [6]
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Sweden
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State/province [6]
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Sundsvall
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Country [7]
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Sweden
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State/province [7]
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Umeå
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Country [8]
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Sweden
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State/province [8]
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Västerås
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Country [9]
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United Kingdom
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State/province [9]
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Scotland
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Country [10]
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United Kingdom
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State/province [10]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Karolinska Institutet
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer. The best proof of NACT efficacy is pathological complete response (pCR), i.e. the absence of invasive tumour on post-NACT surgical histopathology. While it is known that physical exercise can help patients to better tolerate and complete often harsh cancer treatments, it is an emerging area of research to understand if and how exercise exerts anti-tumour effects and improves oncological outcomes. The main aim of the Neo-ACT trial is to examine if a physical exercise intervention during NACT can increase pCR rates in breast cancer. Secondary aims are residual cancer burden, radiological tumour response, patient-related outcomes (health-related quality of life, physical activity), physiological outcomes (muscle strength, cardiorespiratory fitness), cancer treatment-related toxicities (cognitive dysfunction, chemotherapy completion rates) and long-term sick leave. Furthermore, the trial will explore how physical exercise affects anti-tumoral mechanisms inherent to therapy or host by hypothesis-generating translational analyses. 712 patients with primary invasive breast cancer will be randomized to either a supervised intervention of high-intensity interval and resistance training during NACT, supported by an exercise app, or to usual care, and followed for two years. Physical activity is meticulously tracked. By offering patients active involvement, the trial contributes strongly to the concept of personalized medicine.
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Trial website
https://clinicaltrials.gov/study/NCT05184582
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Trial related presentations / publications
de Boniface J, Altena R, Haddad Ringborg C, Bolam KA, Wengstrom Y. Physical exercise during neoadjuvant chemotherapy for breast cancer as a mean to increase pathological complete response rates: Trial protocol of the randomized Neo-ACT trial. PLoS One. 2022 Oct 13;17(10):e0274804. doi: 10.1371/journal.pone.0274804. eCollection 2022.
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Public notes
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Contacts
Principal investigator
Name
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Jana de Boniface
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Address
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Karolinska Institutet
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jana de Boniface
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Address
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Country
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Phone
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+46702472305
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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
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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.
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://ki.se/en/mmk/the-neo-act-trial
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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