Project description
Summary
Question: People with head and neck cancer (HNC) undergoing curative radiotherapy (RT) often experience a decline in health-related quality of life (HRQOL). What is the effect of adding a 12-week Comprehensive Supervised Exercise Program (CSEP), initiated at the start of treatment, to standard care on HRQOL up to one year after RT initiation, compared with standard care alone? Exploratory objectives included evaluating the impact on physical and mental function, activity and participation domains. Feasibility of the CSEP was evaluated based on enrollment and drop-out rates, adherence and safety.
Design: Parallel, two-arm, open-label, single-center randomized controlled trial with concealed allocation and intention-to-treat principle.
Participants: Participants were 130 adults with a primary malignant tumor in the head and neck region, scheduled for curative RT, recruited at the Department of Radiation Oncology, University Hospital Leuven, Belgium. Participants were physically and mentally able to participate in the CSEP and assessments.
Interventions: Both the control and intervention groups received usual supportive care, including dietetic, psychosocial, and speech therapy support as needed. The intervention group received additionally a CSEP, combining aerobic, resistance, and flexibility training. The individualized program started in the first week of RT and consisted of 18 supervised one-hour sessions over 12 weeks (two sessions per week during RT and one per week in the 6 weeks after RT), complemented by additional home-based exercises to achieve the recommended three sessions per week. A maintenance program at home was advised up to one year.
Outcome measures: Primary outcome and key-secondary outcomes were HRQOL (global health status scale) and physical functioning (EORTC QLQ-C30), respectively, at 6 months after RT start. Secondary outcomes included physical and mental function, activity, and participation and evaluation of feasibility (enrollment, drop-out rates, adherence, safety) of the CSEP. Assessments occurred at RT start, 6 weeks, 12 weeks, and 6 months afterwards.
Theme(s): head and neck cancer, exercise therapy, edema, pain, quality of life, oncology, treatment
Kom Op Tegen Kanker (reference number KOTK_KUL/2020/12167/1)
Partners
Kaat Van Aperen: Laboratory of Experimental Radiotherapy, Department of Oncology, University of Leuven; Department of Rehabilitation Sciences and Physiotherapy, University of Leuven
Prof. Dr. An De Groef: Department of Rehabilitation Sciences and Physiotherapy, University of Leuven; Department of Rehabilitation Sciences and Physiotherapy, MOVANT research group, University of Antwerp
Prof. Dr. Thierry Troosters: Department of Rehabilitation Sciences and Physiotherapy, University of Leuven; Respiratory Rehabilitation and Respiratory Division, University Hospitals Leuven
Prof. Dr. Nele Devoogdt: Department of Rehabilitation Sciences and Physiotherapy, University of Leuven; Department of Physical Medicine and Rehabilitation, University Hospitals Leuven; Centre for lymphedema, Department of Vascular Surgery, University Hospitals Leuven
Prof. Dr. Koen Peers: Department of Physical Medicine and Rehabilitation, University Hospitals Leuven; Department of Development and Regeneration, University of Leuven
Dr. Tessa De Vrieze: Department of Rehabilitation Sciences and Physiotherapy, University of Leuven; Department of Rehabilitation Sciences and Physiotherapy, MOVANT research group, University of Antwerp
Dr. Heleen Bollen: Laboratory of Experimental Radiotherapy, Department of Oncology, University of Leuven; Department of Radiation Oncology, Leuven Cancer Institute, University Hospitals Leuven
Prof. Dr. Sandra Nuyts: Laboratory of Experimental Radiotherapy, Department of Oncology, University of Leuven; Department of Radiation Oncology, Leuven Cancer Institute, University Hospitals Leuven
Results
Results: At 6 months, no statistically or clinically significant differences were found between groups for HRQOL or physical functioning. Both groups experienced a decline in HRQOL during RT, with recovery to baseline by 12 weeks and further improvement up to 6 months after RT start. Some secondary outcomes including physical capacity and physical activity levels showed small, non-significant trends favoring the intervention group. Mean adherence to the exercise program was low, with 43% attending at least two-thirds (≥67%) of supervised hospital sessions, and 51% completing at least two-thirds of independent home sessions. No serious adverse events related to the intervention were reported.
Conclusion: A CSEP initiated at the start of RT did not lead to significant improvements in HRQOL nor physical functioning at 6 months after RT start. Selective drop-out, sample heterogeneity, and insufficient achieved exercise dose probably limited effects. The lack of observed benefit—even within subgroups—likely reflects limited efficacy of the intervention itself. Future research should focus on improving program design, content and delivery, integrating adherence-enhancing strategies, and improving integration of existing multidisciplinary care by better aligning nutritional support with exercise.
Funding
Kom Op Tegen Kanker (reference number KOTK_KUL/2020/12167/1)
Publications
https://pubmed.ncbi.nlm.nih.gov/?term=van+aperen
Contact
kaat.vanaperen@kuleuven.be
an.degroef@uantwerpen.be