Effects of Exercise in Patients With Metastatic Breast Cancer

N/AActive Not RecruitingNCT04120298

UMC Utrecht357 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

357

Conditions

Metastatic Breast Cancer

Interventions

Supervised exerciseBEHAVIORAL

An individualised exercise programme supervised by a trained instructor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Utrecht

Utrecht, Netherlands

Outcomes

Primary Outcomes

Cancer-related physical fatigue

Physical fatigue measured with the EORTC QLQ-FA12

Time frame: 0- 6 months (measured at baseline, 3 and 6 months)

Health-related Quality of Life

Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score

Time frame: 0- 6 months (measured at baseline, 3 and 6 months)

Secondary Outcomes

Separate HRQoL domains and Summary Score

EORTC QLQ-C30 function and symptom scores scores

Time frame: 0-9 months

Cancer-related fatigue

EORTC QLQ-FA12 scores

Time frame: 0-9 months

Breast cancer specific symptoms

EORTC QLQ-BR45

Time frame: 0-9 months

Anxiety, depression

PHQ-4

Time frame: 0-9 months

Sleep

PSQI

Time frame: 0-9 months

Pain: severity and its impact on functioning.

BPI

Time frame: 0-9 months

Neuropathic pain

painDETECT

Time frame: 0-9 months

Pain Catastrophizing

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.