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

NCT05218876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-11-28

No results posted yet for this study

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

Interventions

OTHER

Low- to moderate intensity strength and endurance training

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

OTHER

High intensity strength and endurance training

Combination of strength and endurance training with high intensity during chemotherapy

Sponsors & Collaborators

  • Norwegian Cancer Society

    collaborator OTHER
  • University of Agder

    collaborator OTHER
  • Haukeland University Hospital

    collaborator OTHER
  • Uppsala University

    collaborator OTHER
  • Active against Cancer - Norway

    collaborator UNKNOWN
  • Norwegian School of Sport Sciences

    lead OTHER

Principal Investigators

  • Truls Raastad, Professor · Department of Physical Performance, Norwegian School of Sports Science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-08
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05218876 on ClinicalTrials.gov