German Clinical Trials Register

Acronym/abbreviation of the study

KKHR OSA RCT

URL of the study

No Entry

Brief summary in lay language

The study aims to examine patients with head and neck squamous cell carcinoma (KHP) treated with radiation (and possibly chemotherapy) for concomitant obstructive sleep apnea (OSA). To this end 220 patients will be randomized into two groups, who either receive the standard therapy of OSA – an auto-titrating positive pressure therapy (aPAP) – in parallel with the radiation therapy or who do not receive this therapy. The primary endpoint is the numeric score of the fatigue scale of the EORTC QLQ c30 questionnaire. Other endpoints include the apnea/hypopnea index (the standard of severity classification of OSA), cancer-related survival/recurrence, and other patient-reported complaints, which are recorded with additional questionnaires on fatigue, insomnia, physical function, daytime sleepiness, and general sleep quality. For this purpose, an outpatient sleep examination with corresponding survey via questionnaires is carried out in the patients at four different times during the study (before the start of therapy, after radiation and 3 and 6 months after completion of the cancer treatment). For sleep examination, patients are given a home sleep apnea testing device that measures nasal respiratory flow, oxygen saturation in the blood, chest and abdominal movement, brain currents and muscle tension. The aim of the study is to obtain reliable knowledge about the comorbid OSA and its therapy with positive pressure therapy in patients with KHP, with particular consideration given to the development of quality of life with and without treatment. In addition, the effect of the treatment of OSA on overall survival or cancer recurrence rate will be investigated.

Brief summary in scientific language

In this randomized, controlled trial the effect of OSA treatment with nocturnal auto-titrated positive airway pressure (aPAP) therapy in patients with comorbid OSA (diagnosed by portable polysomnography, PSG) and cT2-cT4 HNSCC irrespective of N-nodal status undergoing primary radiation cancer therapy will be investigated. Participants in the intervention group are going to be treated with PAP during the course of radiation therapy (with or without concurrent chemo- or immune-therapy) and for the 6 months following termination of radiation. End points include: patient-reported outcomes (PROs), namely the Symptom Scale Fatigue of EORTC QLQ-C30 version 3.0 (primary end point), apnea / hypopnea index (AHI) as measured by PSG, oncologic outcome (recurrence or death), the other scales of the EORTC QLQ, the Epworth Sleepiness Scale, the Pittsburgh Sleep Quality Index (PSQI), the Insomnia Severity Index (ISI) and the CT-scan-based tumor dimensions before treatment and 3 and 6 months after end of treatment (all secondary end points). In this prospective trial, 220 participants with comorbid OSA and HNSCC will be included. Participants with OSA will be allocated to aPAP-therapy or not using a 2:1 randomization. The aim is to investigate the possible role of OSA as well as the possible effect of aPAP in the overall quality of life outcomes of these patients, with a power of 80% at the 5% significance level. Additionally, a possible effect of aPAP on oncologic outcome / tumor response during radiation because of the improved tumor and body oxygenation will also be evaluated.