Effectiveness of Early Oral Nutritional Supplementation in Preventing Weight Loss in Head and Neck Cancer Patients Undergoing Postoperative Radiotherapy or Chemoradiotherapy: A Prospective Randomized Controlled Trial.

Abstract

Background and objectives: Patients with locally advanced head and neck squamous cell carcinoma (HNSCC) typically undergo surgery followed by postoperative radiotherapy/chemoradiotherpy. Nutritional issues often arise during treatment, potentially affecting outcomes. This study aimed to investigate whether early initiation of oral nutritional supplements (ONS) would prevent weight loss in HNSCC patients undergoing postoperative radiotherapy/chemoradiotherapy compared to conventional nutritional intervention.

Subjects and methods: Sixty-five surgically treated HNSCC patients were randomized to early nutritional intervention (ENI) or conventional nutritional intervention (CNI) groups. The ENI group started ONS two weeks before radiotherapy, while the CNI group initiated ONS based on dietitian's advice when dietary intake was insufficient. Primary endpoint was body weight change from baseline to two weeks post-radiotherapy. Secondary endpoints included nutritional status, body composition, adverse events, quality of life, and survival.

Results: Patients in the ENI group experienced less pronounced weight loss compared to those in the CNI group. Lower serum prealbumin levels were observed in the CNI group during radiotherapy, while no significant between-group differences existed in other nutritional parameters, QoL, or survival.

Conclusion: Early ONS intervention effectively prevented significant weight loss in HNSCC patients undergoing postoperative radiotherapy/chemoradiotherapy. Our findings strongly support prioritizing and integrating early nutritional support with ONS into routine care for this patient population, given its clear benefits in improving nutritional outcomes during treatment.

Clinical trial registration: www.ClinicalTrials.gov. NCT03545490.