Effects of Aerobic Exercise on Cardiorespiratory Fitness, Cardiovascular Risk Factors, and Patient-Reported Outcomes in Long-Term Breast Cancer Survivors: Protocol for a Randomized Controlled Trial.

BACKGROUND: Anthracycline-based chemotherapy has been mainstay of adjuvant breast cancer therapy for decades. Although effective, anthracyclines place long-term breast cancer survivors at risk of late effects, such as reduced cardiorespiratory fitness and increased risk of cardiovascular disease. Previous research has shown beneficial effects of exercise training on cardiorespiratory fitness, but the effects of exercise on limiting factors for cardiorespiratory fitness, cardiovascular risk factors, and patient-reported outcomes in long-term survivors are less clear. Whether previous exposure to breast cancer therapy modulates the effects of exercise is also unknown. OBJECTIVE: The primary aim of the CAUSE (Cardiovascular Survivors Exercise) trial is to examine the effect of aerobic exercise on cardiorespiratory fitness in anthracycline-treated long-term breast cancer survivors. Secondary aims are to examine effects of exercise training on limiting factors for cardiorespiratory fitness, cardiovascular risk factors, and patient-reported outcomes, and to compare baseline values and effects of exercise training between similar-aged women with and those without prior breast cancer. A third aim is to examine the 24-month postintervention effects of aerobic exercise on primary and secondary outcomes. METHODS: The CAUSE trial is a 2-armed randomized controlled trial, where 140 long-term breast cancer survivors, 8-12 years post diagnosis, are assigned to a 5-month nonlinear aerobic exercise program with 3 weekly sessions or to standard care. Seventy similar-aged women with no history of cancer will undergo the same exercise program. Cardiorespiratory fitness measured as peak oxygen consumption (VO2peak), limiting factors for VO2peak (eg, cardiac function, pulmonary function, hemoglobin mass, blood volume, and skeletal muscle characteristics), cardiovascular risk factors (eg, hypertension, diabetes, dyslipidemia, obesity, physical activity level, and smoking status), and patient-reported outcomes (eg, body image, fatigue, mental health, and health-related quality of life) will be assessed at baseline, post intervention, and 24 months post intervention. RESULTS: A total of 209 patients were included from October 2020 to August 2022, and postintervention assessments were completed in January 2023. The 24-month follow-up will be completed in February 2025. CONCLUSIONS: The findings from the CAUSE trial will provide novel scientific understanding of the potential benefits of exercise training in long-term breast cancer survivors. TRIAL REGISTRATION: ClinicalTrials.gov NCT04307407; https://clinicaltrials.gov/ct2/show/NCT04307407. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45244.

Correction: Effects of Aerobic Exercise on Cardiorespiratory Fitness, Cardiovascular Risk Factors, and Patient-Reported Outcomes in Long-Term Breast Cancer Survivors: Protocol for a Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/45244.].

Retinal nerve fibre layer attenuation: clinical indicator for vigabatrin toxicity.

PURPOSE: To investigate whether persistent visual field defects among patients exposed once to the antiepileptic drug vigabatrin (VGB) were associated with peripapillary retinal nerve fibre layer thickness (RNFLT) attenuation. METHODS: Nine individuals with partial epilepsy and VGB-attributed visual field loss (group 1; 18 eyes) and seven age- and gender-matched individuals with epilepsy and no previous VGB exposure (group 2; 14 eyes) were included in the study. Full-field 120 point screening perimetry out to 60 degrees from central fixation using the Humphrey Field Analyzer was performed. RNFLT was quantified by optical coherence tomography (OCT) using Fast RNFLT protocol, Stratus OCT (3.0) after pupillary dilation. The results from the right eye are presented in this article. RESULTS: Among the patients with VGB-attributed visual field loss, five patients had only peripheral field defect (group 1a) and the remaining four had advanced field defects both in the periphery and within 30° from central fixation (group 1b). None of the patients in the control group had manifest visual field loss. The mean RNFLT among the patients with VGB-attributed visual field loss was significantly attenuated compared to the controls [mean total RNFLT: group 1: 75.6 ± 12.7 µm, group 2: 103.5 ± 9.7 µm, mean difference 27.9 µm, (CI 15.9-39.9; p < 0.001)]. RNFLT values classified as borderline according to normative database (Stratus OCT) occurred more frequently among individuals with VGB-attributed visual field loss than in controls (frequency in group 1: 6/9; group 2: 0/7, p = 0.011). The nasal, superior and inferior quadrants of RNFLT in individuals with VGB-attributed visual field loss were significantly attenuated, while no difference was detected in temporal quadrants compared to controls. Both individuals with peripheral and those with advanced visual field losses in the VGB group had attenuated mean total RNFLT compared to controls (p = 0.006, p = 0.002, respectively). Occurrence of borderline classification of total RNFLT ≤5th percentile was more frequent among individuals with advanced visual field loss than among controls (p = 0.048). CONCLUSION: Persistent visual field loss attributed to VGB is associated with reduced peripapillary RNFLT and was detected both among patients with advanced and among patients with only peripheral visual field defects. Measurements of RNFLT with OCT might be considered as a diagnostic supplement in the follow-up of patients exposed to vigabatrin.