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Clinical Trial
. 2024 May 7;4(5):1211-1226.
doi: 10.1158/2767-9764.CRC-23-0148.

Stay on Track: A Pilot Randomized Control Trial on the Feasibility of a Diet and Exercise Intervention in Patients with Breast Cancer Receiving Radiotherapy

Affiliations
Clinical Trial

Stay on Track: A Pilot Randomized Control Trial on the Feasibility of a Diet and Exercise Intervention in Patients with Breast Cancer Receiving Radiotherapy

Gopika SenthilKumar et al. Cancer Res Commun. .

Abstract

Purpose: Among patients with breast cancer undergoing radiotherapy, posttreatment cardiovascular disease and worsened quality of life (QoL) are leading causes of morbidity and mortality. To overcome these negative radiotherapy effects, this prospective, randomized clinical trial pilots a 12-week Stay on Track exercise and diet intervention for overweight patients with nonmetastatic breast cancer undergoing whole-breast radiotherapy.

Experimental design: The intervention group (n = 22) participated in three personal exercise and dietary counseling sessions, and received three text reminders/week to adhere to recommendations. The control group (n = 22) was administered a diet/exercise information binder. All patients received a Fitbit, and at baseline, 3 months, and 6 months, measurements of biomarkers, dual-energy X-ray absorptiometry scans, QoL and physical activity surveys, and food frequency questionnaires were obtained. A satisfaction survey was administered at 3 months.

Results: Stay on Track was well received, with high rates of adherence and satisfaction. The intervention group showed an increase in self-reported physical activity and preserved QoL, a decrease in body mass index and visceral fat, and higher American Cancer Society/American Institute of Cancer Research dietary adherence. The control participants had reduced QoL, anti-inflammatory markers, and increased metabolic syndrome markers. Both groups had decreased overall body mass. These changes were within group effects. When comparing the intervention and control groups over time, there were notable improvements in dietary adherence in the intervention group.

Conclusions: Targeted lifestyle interventions during radiotherapy are feasible and could decrease cardiovascular comorbidities in patients with breast cancer. Larger-scale implementation with longer follow-up can better determine interventions that influence cardiometabolic health and QoL.

Significance: This pilot study examines cardiometabolic benefits of a combined diet and exercise intervention for patients with breast cancer undergoing radiotherapy. The intervention included an activity tracker (FitBit) and text message reminders to promote adherence to lifestyle interventions. Large-scale implementation of such programs may improve cardiometabolic outcomes and overall QoL among patients with breast cancer.

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Figures

FIGURE 1
FIGURE 1
Study timeline.
FIGURE 2
FIGURE 2
FitBit activity levels. Percent change in average total steps per day (A), average total active minutes per day (B), and average active minutes per day (C) in the intervention group compared with their baselines. Total steps per day (D), total active minutes per day (E), and total very active minutes per day (F) during the baseline week in the intervention and control groups. Graphs show mean ± SE. *, P < 0.05.

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