Preventing Xerostomia in HNSCC Radiotherapy

We undertook a phase 3 randomised controlled trial at six UK radiotherapy centres (recruitment between Jan 21, 2003, and Dec 7, 2007). Eligible patients had histologically confirmed HNSCC that arose from the oropharynx or hypopharynx and were to be treated by radiotherapy either primarily or postoperatively without concomitant chemotherapy. These patients were at high risk of radiation-induced xerostomia—ie, if they were treated with conventional radiotherapy the estimated mean dose to both parotid glands would be greater than 24 Gy. Patients had WHO performance status 0 or 1 and any stage of disease except M1. Patients were required to attend regular follow-up, undergo salivary flow measurements, and complete self-assessed QoL questionnaires.
Exclusion criteria included previous head or neck radiotherapy; previous malignancy except non-melanoma skin cancer; pre-existing salivary gland disease; tumour involvement of the parotid glands; or previous or concurrent illness that would compromise completion of treatment or follow-up. Prophylactic amifostine or pilocarpine was not permitted. Patients who had received neoadjuvant chemotherapy were eligible.
All patients provided written informed consent. PARSPORT (CRUK/03/005) was approved by the national South-West Multicentre Research Ethics Committee (MREC 03/6/79) and the local ethics committees of all participating centres. Our trial was sponsored by the Royal Marsden NHS Foundation Trust and undertaken in accordance with the principles of Good Clinical Practice.