Effects of Moderate and High-intensity Exercise During Chemotherapy on Muscle Cells in Women With Breast Cancer

NCT05218876 | Completed

• 1 other identifier: PhysCan muskel
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

(Neo-)adjuvant chemotherapy for breast cancer has deleterious effects on muscle tissue resulting in reduced skeletal muscle mass, muscle function, and cardiorespiratory fitness. Various exercise regimens during cancer treatment have been shown to counteract some of these side effects. However, no study has compared the effect of high intensity training vs. low-to moderate intensity training on muscle tissue cellular outcomes and function in breast cancer patients during chemotherapy. The present study aims to compare the effects of high vs. low-to moderate intensity training on its ability to counteract deleterious effects of chemotherapy on skeletal muscle in women diagnosed with breast cancer. Eighty newly diagnosed women with breast cancer planned to start (neo-)adjuvant chemotherapy will be randomized to either a group performing a combination of strength and endurance training with high intensity or a group performing training with low to moderate intensity. Muscle biopsies from m. vastus lateralis for assessment of muscular cellular outcomes will be collected and muscle function and cardiorespiratory fitness will be measured before the first cycle of chemotherapy (or, when not possible, one week after) (T0), halfway through chemotherapy (T1), and after completion of chemotherapy (T2). It is estimated that approximately 50% will be willing to take muscle biopsies. The study will give important information about the effects of different training intensities for breast cancer patients during treatment and will contribute with knowledge about how to refine exercise programs that are effective and compatible with multidisciplinary management of breast cancer.

Conditions

Breast Cancer Female

Keywords

Muscle fiber cross-sectional area; Muscle biopsies; Training; Oncology; Strength training; Endurance training

Outcome Measures

Primary Outcomes (1)

• Muscle fiber cross-sectional area

  Change from baseline (T0) to end of intervention (end of training and treatment), approximately 6 months (T2) in muscle fiber cross-sectional area. This will be assessed by immunohistochemical staining of muscle fiber cross-sections for type 1 and type 2 muscle fibers and dystrophin (cell border).

  From baseline (T0) to the 6 months time point (end of treatment and training, T2)

Secondary Outcomes (12)

• Muscle fiber cross-sectional area

  From baseline (T0) to the 3 months time point (halfway into the treatment and training,T1)

• Satellite cell content in muscle fiber cross-sections

  From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)

• Myonuclei content in muscle fiber cross-sections

  From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)

• 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 (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)

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

  From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)

Other Outcomes (9)

• Blood lipids

  From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)

• C-reactive protein

  From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)

• Creatine kinase

  From baseline (T0) to the 3 months time point (T1) and from baseline to the 6 months time point (T2)

Study Arms (2)

Low- to moderate intensity strength and endurance training

EXPERIMENTAL

Participants will perform a combination of strength and endurance training with low-to moderate-intensity during (neo-) adjuvant treatment with chemotherapy, approximately 6 months. All strength training will be supervised while the endurance training is home-based and followed up by a coach.

Other: Low- to moderate intensity strength and endurance training

High intensity strength and endurance training

EXPERIMENTAL

Participants will perform a combination of strength and endurance training with high intensity during (neo-) adjuvant treatment with chemotherapy, approximately 6 months. All strength training will be supervised while the endurance training is home-based and followed up by a coach.

Other: High intensity strength and endurance training

Interventions

Low- to moderate intensity strength and endurance training OTHER

Combination of strength and endurance training with low- to moderate intensity during chemotherapy

Low- to moderate intensity strength and endurance training

High intensity strength and endurance training OTHER

Combination of strength and endurance training with high intensity during chemotherapy

High intensity strength and endurance training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with stage I-III breast cancer
• years old
• can understand and communicate in the Norwegian language
• scheduled to undergo (neo-)adjuvant chemotherapy with a combination of taxanes and anthracyclines or only one of the 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)

Sponsors & Collaborators

• Norwegian School of Sport Sciences: lead
• Norwegian Cancer Society: collaborator
• University of Agder: collaborator
• Haukeland University Hospital: collaborator
• Uppsala University: collaborator
• Active against Cancer - Norway: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Vestlandet, 5021, Norway

Location

Related Publications (1)

• Vikmoen O, Wiestad TH, Thormodsen I, Nordin K, Berntsen S, Demmelmaier I, Strandberg E, Raastad T. Effects of High and Low-To-Moderate Intensity Exercise During (Neo-) Adjuvant Chemotherapy on Muscle Cells, Cardiorespiratory Fitness, and Muscle Function in Women With Breast Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Nov 11;11(11):e40811. doi: 10.2196/40811.

  PMID: 36367769 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Endurance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Truls Raastad, Professor

  Department of Physical Performance, Norwegian School of Sports Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person performing all analyses on muscle tissue (primary outcome) is masked for intervention applied to the individuals and timepoint. The person doing the physical test is not masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: December 8, 2016
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)