NCT04586517

Brief Summary

(Neo-)adjuvant chemotherapy for breast cancer is known to have a negative impact on muscle tissue resulting in reduced aerobic fitness, skeletal muscle mass and strength. Physical exercise during treatment may counteract some of these negative effects. However, the effects of resistance training alone have never been explored. The present study aims to investigate if heavy-load resistance training during (neo-)adjuvant chemotherapy counteracts negative effects on skeletal muscle in women diagnosed with breast cancer. The hypothesis is that (neo-)adjuvant treatment with chemotherapy will reduce muscle fiber size, impair mitochondrial function and increase indicators of cellular stress and that resistance training during treatment will counteract these negative effects. Fifty women recently diagnosed with breast cancer scheduled to start (neo-)adjuvant chemotherapy will be randomized to either an intervention group or a control group. The intervention group will perform supervised heavy-load resistance training twice a week over the course of chemotherapy (approximately 16-weeks) whereas the control group will be encouraged to continue with their usual activities. To increase interest in participation, controls will be invited to a 2-week introduction to the same resistance-training program as the intervention group following completion of chemotherapy. Muscle biopsies from m. vastus lateralis will be collected before the first cycle of chemotherapy, after chemotherapy, and 6 months later (6-month follow-up) for assessment of muscle cellular outcomes. Results from this intervention will provide further knowledge on how chemotherapy affects muscle tissue and how resistance training may counteract immediate and long-term treatment side effects. Results from this intervention will also contribute with knowledge about how to improve exercise programs that are effective for women undergoing chemotherapy against breast cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

3.1 years

First QC Date

September 25, 2020

Last Update Submit

November 1, 2022

Conditions

Breast Cancer Female

Keywords

Breast cancerResistance trainingChemotherapyRandomized controlled trialMuscle biopsiesCross-sectional fiber area

Outcome Measures

Primary Outcomes (1)

  • Assessment of changes in muscle fiber cross-sectional area

    Change from baseline in muscle fiber cross-sectional area at 16 weeks. Through immunohistochemical staining of muscle fiber cross-sections will muscle fiber area be assessed for type 1 and type 2 muscle fibers

    From baseline to the 16 week time-point

Secondary Outcomes (9)

  • Assessment of changes in muscle fiber cross-sectional area

    From baseline to 6-month follow-up

  • Assessment of changes in satellite cell content in muscle fiber cross-sections

    From baseline to the 16 week time-point and from baseline to 6-month follow-up

  • Assessment of changes in myonuclei content in muscle fiber cross-sections

    From baseline to the 16 week time-point and from baseline to 6-month follow-up

  • Assessment of protein levels of regulators of muscle fiber size (proteins involved in muscle protein synthesis and protein degradation (e.i. mTOR, MuRF, S6K1, p70S6k)

    From baseline to the 16 week time-point and from baseline to 6-month follow-up

  • Assessment of changes in protein levels of regulators of muscle fiber cellular stress (Heat Shock proteins: Hsp 27, αB-crystalline, Hsp 60 and Hsp 70)

    From baseline to the 16 week time-point and from baseline to the 6-month follow-up

  • +4 more secondary outcomes

Other Outcomes (12)

  • Assessment of changes fat free mass

    From baseline to the 16 week time-point and from baseline to the 6-month follow-up

  • Assessment of changes in fat mass

    From baseline to the 16 week time-point and from baseline to the 6-month follow-up

  • Assessment of blood lipids

    From baseline to the 16 week time-point and from baseline to the 6-month follow-up

  • +9 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will receive supervised heavy-load resistance training twice a week during treatment with chemotherapy (approximately 16-weeks). After end of chemotherapy, participants will be encouraged to continue the training program and are provided with 12-month membership at a local gym.

Other: Heavy-load resistance training

Control group

ACTIVE COMPARATOR

Participants will be encouraged to continue with their usual activities during chemotherapy and not start resistance training (approximately 16-weeks). After end of chemotherapy participants will be offered to attend a 2-week introduction to the strength-training program and provided with a 12-month membership at a local gym.

Other: Control

Interventions

Heavy-load resistance trainingOTHER

Supervised heavy-load resistance training during chemotherapy treatment

Also known as: Physical exercise, Physical training
Intervention group
ControlOTHER

Activity as usual during chemotherapy

Also known as: usual care
Control group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women diagnosed with stage I-III breast cancer
  • literate in Swedish
  • scheduled to undergo (neo-)adjuvant chemotherapy with a combination of taxanes and anthracyclines or only one of these treatments

You may not qualify if:

  • unable to perform basic activities of daily living
  • cognitive disorders or severe emotional instability
  • other disabling comorbidities that might hamper physical training (e.g. severe heart failure, chronic obstructive pulmonary disease, orthopedic conditions, and neurological disorders)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (3)

  • Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.

    PMID: 39606939DERIVED

  • Mazzoni AS, Strandberg E, Borjeson S, Sjovall K, Berntsen S, Demmelmaier I, Nordin K. Reallocating sedentary time to physical activity: effects on fatigue and quality of life in patients with breast cancer in the Phys-Can project. Support Care Cancer. 2023 Feb 4;31(2):151. doi: 10.1007/s00520-023-07614-9.

    PMID: 36738358DERIVED

  • Strandberg E, Vassbakk-Svindland K, Henriksson A, Johansson B, Vikmoen O, Kudren D, Schauer T, Lindman H, Warnberg F, Berntsen S, Demmelmaier I, Nordin K, Raastad T. Effects of heavy-load resistance training during (neo-)adjuvant chemotherapy on muscle cellular outcomes in women with breast cancer. Medicine (Baltimore). 2021 Mar 12;100(10):e24960. doi: 10.1097/MD.0000000000024960.

    PMID: 33725859DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ExercisePhysical Conditioning, Human

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Truls Raastad, PhD

    Norweigan School of Sport Sciences

    PRINCIPAL INVESTIGATOR

  • Karin Nordin, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 14, 2020

Study Start

December 5, 2018

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

November 2, 2022

Record last verified: 2022-11

Locations

SE(1)