Background: Early palliative care is an important aspect of palliative treatment but has never been evaluated in head and neck cancer. Hence we performed this study. Methods: This was an open-label phase 3 randomised study which enrolled adult patients with squamous cell carcinoma of the head and neck region which warranted palliative systemic therapy. They were 1:1 allocated to either systemic therapy with (EPC arm) or without the addition of early palliative care service (STD arm). Patients were administered the Edmonton Symptom Assessment Scale (ESAS-r) and FACIT HN questionnaire at baseline and 4 weekly thereafter for 12 weeks. The primary endpoint was change in the quality of life (QOL) measured using FACIT HN 12 weeks after randomization. The secondary endpoints were changed in symptom burden at 12 weeks in ESAS-r and overall survival. A repeated-measures analysis of covariance (ANCOVA) was performed to examine the effects of arm and stratum on change in QOL (or symptom score), after controlling for baseline score. Results: Ninety patients were randomised in each arm between 1st June 2016 to 14th August 2017. The compliance with the questionnaires was 100% at baseline. In EPC arm the 70 patients were alive at 3 months and 67 (95.7%) completed the FACIT HN and 64 (91.4%) completed ESAS-r questionnaires. While in the STD arm out of 69 alive the corresponding figures were 61(88.4%) and 59 (85.5%) respectively. There was no statistical difference in change in QOL scores and ΔESAS-r at 12 weeks between the 2 arms (Table). The median overall survival was similar between the 2 arms. (Hazard ratio for death-1.006 (95%CI 0.7347-1.346)). Conclusion: In this phase 3 study, integration of early palliative care in head and neck cancer patients did not result in improvement in the quality of life scores, symptom scores or overall survival. Clinical trial information: CTRI/2016/03/006693.

Table depicting the mean delta (Δ) scores with the interquartile range at 12 weeks.