Purpose: Radiation therapy can cause acute and long-term side effects despite advances in treatment delivery techniques. While significant research has been conducted to prevent the occurrence of toxicity, there is a need for evidence-based supportive care measures to manage radiation side effects. This analysis aims to examine the current state of supportive care trials in radiation oncology and identify areas that require further study.
Methods: A Clinicaltrials.gov search was conducted using the term "radiation toxicity" to identify registered trials with a primary endpoint of toxicity management. These studies were further classified as supportive care interventions or toxicity prevention. Study details were evaluated for all supportive care trials.
Results: Of the thirty-eight supportive care trials identified, most were observational/uncategorized (50%), in phase III (28.9%), or phase II (13.2%). Head and neck (42.1%), genitourinary (18.4%), and breast (13.2%) were the most studied disease sites. Xerostomia (23.7%), mucositis (18.4%), and dermatitis (18.4%) were the most evaluated toxicities. Medication-based (28.9%), procedures (28.9%), and topical agents (21.1%) were the most common interventions. Thirty-two studies included patient-reported outcomes (PROs; 84.2%), of which seventeen trials (53.1%) had PROs as a primary endpoint.
Conclusions: Only a small portion of supportive care trials generate high-level evidence to evaluate interventions with patient-reported endpoints. More supportive care trials are needed to effectively manage radiation toxicities and promote compliance and long-term quality of life during and after radiation therapy. Increased funding from government and industry sponsors is required to support this research.
Keywords: Clinical trials; Patient-reported outcomes; Radiation toxicity; Supportive care trials.
© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.