Page 114 - Functional impairment and cues for rehabilitation of head and neck cancer patients -

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Chapter 5
METHODS
Ethical considerations
This study was approved by the Institutional Review Board of the Netherlands Cancer Institute – Antoni van Leeuwenhoek (NKI-AVL) (IRBd19044).
Patient selection
All patients diagnosed with head and neck cancer in the NKI-AVL, a tertiary cancer center, are followed up in ongoing prospective assessments by speech-language pathologists, who intensively monitor functional limitations before, during and after treatment and start (additional) targeted rehabilitation.
For this analysis, Dutch speaking patients were included who were curatively treated with primary RT or RT+ (RT with cisplatin or cetuximab) for a stage III-IV squamous cell carcinoma of the oropharynx between January 2013 and September 2018. Patients were excluded in case of distant metastases, a synchronous primary tumor elsewhere, prior treatment of the head and neck area (except neck dissection or skin lesions), missing pre-treatment assessment data or if only pretreatment assessment data were available. Patients were excluded from follow-up of this study when additional oncological treatment was given due to residual or recurrent disease.
Radiotherapy based treatment
According to protocol, the treatment consisted of radiotherapy given with 6 MV photons up to 70 Gy in 35 fractions in six weeks in case of RT alone and seven weeks in case of RT+ using sequential of simultaneous integrated boost (SIB) according to the IMRT technique (either step and shoot or VMAT). Patients receiving sequential integrated boost were given an elective dosage of 46 Gy (23 fractions of 2 Gy) with a total dosage of 70 Gy (35 fractions of 2 Gy). Patients receiving simultaneous integrated boost were given an elective dosage of 54.25 Gy (35 fractions of 1.55 Gy) with a total dosage of 70 Gy (35 fractions of 2 Gy).
Concurrent systemic treatment (which was indicated in case of stage N2b or higher or extranodal spread) consisted of cisplatin or cetuximab. Cisplatin was administered intravenously either in high-dose (100mg/m2 at day 1, 22 and 43 of radiotherapy), intermediate-dose (40mg/m2 every week), or low-dose (6mg/m2 daily during the first 5 weeks of radiotherapy). Cetuximab was given when patients were unfit for cisplatin. One week before the start of RT, a loading dose of 400 mg/m2 was administered, followed by 250 mg/m2 weekly during 7 weeks.
Preventive rehabilitation protocol
Since studies have suggested benefit of preventive rehabilitation during RT(+), in April 2008 a preventive rehabilitation protocol was introduced in the NKI-AVL (22). All RT+ patients and all RT patients, from the start of 2016, were instructed to perform preventive swallowing and mouth opening exercises daily from the start of treatment up until at least three months afterwards (23).