Clinical trial NCT04120298: Effects of Exercise in Patients With Metastatic Breast Cancer
Official title: Effects of Structured and Individualized Exercise in Patients With Metastatic Breast Cancer on Fatigue and Quality of Life
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: exercise
cancer-related fatigue
quality of life
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
name: Australian Catholic University
name: Karolinska Institutet
name: The Netherlands Cancer Institute
name: Medical University of Gdansk
name: Fundación Onkologikoa Fundazioa
name: Europa Donna
name: German Sport University, Cologne
name: University Hospital Heidelberg
name: Nurogames GmbH, Cologne
First posted: 2019-10-09
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Currently, the effect of exercise on metastatic breast cancer has not been extensively studied, even though the benefits are evident in the curative setting. The investigators designed the EFFECT study to assess the effects of a 9-month structured and individualised exercise intervention in 350 patients with metastatic breast cancer (stage IV) on cancer-related physical fatigue, Health-Related Quality of Life (HRQoL), and other disease and treatment-related side effects at six months (primary endpoint).

Detailed description: The EFFECT study is a multicentre, randomised controlled trial. The intervention group will participate in a 9-month exercise intervention. The exercise program will start with a 6-month period, where patients participate in a supervised multimodal exercise program twice a week supplemented with unsupervised exercises. The multimodal exercise program comprises aerobic-, resistance- and balance components. After completing the initial six-month period, one supervised session will be replaced by one unsupervised session until month nine.

Unsupervised exercises will be supported by an activity tracker (FitBit) and an exercise App specifically designed for the EFFECT trial. Patients randomized to the control group will also receive an activity tracker (like the intervention group). The investigators will advice control patients to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150min/week in line with the current exercise guidelines.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of breast cancer stage IV
* ECOG (Eastern Cooperative Oncology Group scale) performance status ≤ 2
* Able and willing to perform the exercise program and wear the activity tracker

Exclusion Criteria:

* A potential subject who meets any of the following criteria is not eligible for enrolment into this study:

  * Unstable bone metastases inducing skeletal fragility as determined by the treating clinician
  * Untreated symptomatic known brain metastasis
  * Estimated life expectancy \< 6 months as determined by the treating clinician
  * Serious active infection
  * Too physically active (i.e. \>210 minutes/week of moderate-to-vigorous intentional exercise
  * Severe neurologic or cardiac impairment according ACSM criteria
  * Uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise
  * Uncontrolled severe pain
  * Any other contraindications for exercise as determined by the treating physician
  * Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician
  * Pregnancy

Primary outcomes:
measure: Cancer-related physical fatigue
timeFrame: 0- 6 months (measured at baseline, 3 and 6 months)
measure: Health-related Quality of Life
timeFrame: 0- 6 months (measured at baseline, 3 and 6 months)
Secondary outcomes:
measure: Separate HRQoL domains and Summary Score
timeFrame: 0-9 months
measure: Cancer-related fatigue
timeFrame: 0-9 months
measure: Breast cancer specific symptoms
timeFrame: 0-9 months
measure: Anxiety, depression
timeFrame: 0-9 months
measure: Sleep
timeFrame: 0-9 months
measure: Pain: severity and its impact on functioning.
timeFrame: 0-9 months
measure: Neuropathic pain
timeFrame: 0-9 months
measure: Pain Catastrophizing
timeFrame: 0-9 months
measure: Treatment-related toxicities grade≥3
timeFrame: 0-9 months
measure: Weight
timeFrame: 0-6 months
measure: Height
timeFrame: 0-6 months
measure: Waist circumference
timeFrame: 0-6 months
measure: Body composition (fat free mass and fat mass)
timeFrame: 0-6 months
measure: Physical activity (subjective)
timeFrame: 0-6-9 months
measure: Physical activity (objective)
timeFrame: 0-6-9 months
measure: Resting heart rate
timeFrame: 0-6 months
measure: Blood pressure
timeFrame: 0-6 months
measure: Physical performance
timeFrame: 0-6 months
measure: Physical fitness
timeFrame: 0-6 months
measure: Work status/ healthcare resources consumption
timeFrame: 0-9 months
measure: Intervention costs
timeFrame: 0-9 months
measure: Health status
timeFrame: 0-9 months
measure: Satisfaction with exercise intervention
timeFrame: 0-9 months
measure: Biomarkers (systemic inflammation, growth factors, blood/brain barrier modulators)
timeFrame: 0-6 months
measure: Disease control
timeFrame: 0-9 months
measure: Cancer treatment
timeFrame: 0-9 months
measure: Quality of working life
timeFrame: 0-9 months
Other outcomes:
measure: Overall and breast-cancer specific survival
timeFrame: 0-60 months
measure: Progression-free survival
timeFrame: 0-60 months
measure: Safety of exercise intervention
timeFrame: 0-9 months
measure: Urinary incontinence
timeFrame: 0-9 months
measure: Maximal isokinetic and isometric leg strength, muscle thickness of m. rectus femoris (RF) and m. vastus lateralis (VL)
timeFrame: 0-9 months
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht Julius Center
name: Anne May, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hiensch AE, Monninkhof EM, Schmidt ME, Zopf EM, Bolam KA, Aaronson NK, Belloso J, Bloch W, Clauss D, Depenbusch J, Lachowicz M, Pelaez M, Rundqvist H, Senkus E, Stuiver MM, Trevaskis M, Urruticoechea A, Rosenberger F, van der Wall E, de Wit GA, Zimmer P, Wengstrom Y, Steindorf K, May AM. Design of a multinational randomized controlled trial to assess the effects of structured and individualized exercise in patients with metastatic breast cancer on fatigue and quality of life: the EFFECT study. Trials. 2022 Jul 29;23(1):610. doi: 10.1186/s13063-022-06556-7.