RESUMEN
PURPOSE: To explore current practice variation and degree of consensus among international clinical experts regarding the diagnosis, classification, measurement, and treatment of head and neck lymphedema (HNL) after head and neck cancer treatment. MATERIALS AND METHODS: We conducted an online Delphi study. Eligible participants were clinical researchers who had (co)authored at least one publication on HNL and healthcare professionals who had treated at least five patients with HNL the last two years. The first round was to collect views about current best practices. The second and third rounds delved deeper into these topics using statements with 7-point adjective rating scales. RESULTS: An expert panel of seventeen participants (7 clinicians, 8 researchers, and 2 others) from 8 countries completed all rounds. Regarding diagnosis, there was limited consensus on most subjects, with palpation being most endorsed. No consensus was reached on the need to use standardized classification systems. As a treatment method, complex decongestive therapy (CDT) was the most commonly used in practice and investigated in the literature. However, no consensus was reached on the importance of aspects of CDT. CONCLUSIONS: There is substantial intra- and international practice variation in the management of HNL. This calls for more robust evidence and guidelines.
Currently there is little consensus and strong practice variation in head and neck lymphedema management.Clinicians should be aware that colleagues may have different opinions about the essential components of complex decongestive therapy.Sharing of best practices between rehabilitation clinicians should be encouraged to obtain practice-based evidence.At this stage, no firm recommendations can be derived on the use of complex decongestive therapy, given the various opinions expressed by clinicians and researchers in this study.
RESUMEN
BACKGROUND: With over 500,000 annually reported cases worldwide, head and neck cancer (HNC) is the seventh most common type of cancer worldwide. Treatment of HNC with chemoradiotherapy frequently results in serious impairments in physical and psychosocial functioning. Besides, HNC patients typically start their cancer treatment already with poor physical and psychosocial health. It has been shown that a sufficient level of physical activity (PA) before, during, and after cancer treatment is associated with fewer negative treatment-related side effects and a better quality of life (QOL). In order to prevent worsening of functioning and limit the physical impact of the HNC treatment, a comprehensive supervised exercise program (CSEP) may be beneficial during early cancer treatment. However, up to now, the feasibility and effectiveness of such a program are not yet investigated thoroughly in HNC. Therefore, the primary objective of this study is to examine the effectiveness of a CSEP during HNC treatment, in addition to usual supportive care, compared to usual supportive care alone, on health-related QOL up to 1 year post-diagnosis. Secondary objectives entail gathering information on (1) the effectiveness of a CSEP on secondary outcomes such as physical and mental function, activities of daily life, and participation in society and (2) the feasibility, possible barriers, and facilitators for participation in a CSEP during HNC treatment. METHODS: To investigate the effectiveness of the CSEP, a parallel, open-label randomized controlled trial will be performed. To study the feasibility of the CSEP, a mixed-method study will be performed in a subgroup of participants. HNC patients are eligible if they receive radiotherapy at the Radiation-Oncology department of the University Hospital of Leuven. A 4-size permuted block randomization will be used. The control group receives the current standard of supportive care. The intervention group receives a CSEP, additional to the same usual supportive care. The CSEP consists of a 12-week intensive phase with 3 exercise sessions of 1 h per week, where supervision is gradually reduced after 6 weeks. During the maintenance phase (from week 13), patients exercise at home with monthly tele-consultations with a physiotherapist. The CSEP contains supervised aerobic and resistance training. In both groups, outcomes of interest are evaluated through self-reported questionnaires and clinical assessments, at baseline, 6 weeks, 12 weeks, 6 months, and 12 months post-diagnosis. The primary endpoint is health-related QOL, measured with the EORTC QLQ-C30 at 6 months post-diagnosis. DISCUSSION: The study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the ethical committee of the University Hospitals Leuven (s65549). Recruitment started in January 2022. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses. TRIAL REGISTRATION: Trial Registration: ClinicalTrials.gov Identifier: NCT05256238 Date of registration: February 25, 2022.