Comparing Prophylactic and Reactive Feeding Tube Placement for Swallowing and Quality of Life in Adults with Advanced Oropharyngeal Cancer Receiving Chemo-radiotherapy

What this Trial Is About

Researchers are evaluating swallowing function and quality of life in patients with oropharyngeal cancer treated with chemo-radiotherapy in this open-label, randomized phase III study. The study compares two approaches for placing a percutaneous endoscopic gastrostomy PEG tube prophylactic placement before treatment versus reactive placement during treatment if nutritional intake decreases significantly. All participants will receive standard cisplatin chemotherapy combined with intensity modulated radiotherapy IMRT. Participants are randomly assigned to one of two groups. The first group receives a prophylactic PEG tube before starting chemoradiotherapy, with enteral nutrition guided by a dietitian to meet energy and protein needs. The second group receives a reactive PEG tube if oral intake falls below two-thirds of estimated energy requirements for more than seven days or if weight loss exceeds 5% from baseline. Chemotherapy involves cisplatin given either as two doses on days 1 and 22 or weekly doses on days 1, 8, 15, 22, 29, and 36. Radiotherapy uses a simultaneous integrated boost IMRT with specific dose prescriptions to the tumor and elective areas. Participants will be monitored through multiple assessments including swallowing function measured by the M.D. Anderson Dysphagia Inventory at six months post-treatment, quality of life evaluations at baseline and various points up to 24 months, and treatment-related toxicities throughout the study. Clinical tumor response and longer-term outcomes will be assessed at 3, 12, and 36 months after treatment. Nutritional status, tobacco use, HPV status, and cost-effectiveness of the treatment strategies will also be evaluated. The total study duration includes screening, treatment, and extended follow-up periods to fully capture patient outcomes.

Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy