Journal of Cancer Clinical Trials

Rationale and Design of a Trial for Prophylactic Nutritional Support (Pronus) During Treatment for Head and Neck Cancer: A Single-Center, Randomized, Controlled Trial Comparing Effects of Percutaneous Endoscopic Gastrostomy Tube and Nasogastric Tube Placement on Nutritional Status of Patients

Abstract

M Aasim Yusuf, Faisal Zeb, M Qayyum Khan, Syed Raza Hussain, Hala Mansoor, M Adnan Masood, Arif Jamshed and Waleed Zafar

Background: Prophylactic nutritional support of head and neck cancer patients being treated with chemoradiation through placement of either a percutaneous endoscopic gastrostomy (PEG) tube or a nasogastric (NG) tube is well-established in clinical care. There is, however, little scientific evidence to support one over the other.

Methods: We planned to conduct a randomized controlled trial to compare the effects of PEG tube or NG tube on nutritional status and quality of life of patients; the rates of clinical complications; and the cost of care. The trial was conducted at a tertiary care cancer specialist center in Lahore, Pakistan.

Results: The study was closed early because of refusal of eligible patients to be randomly assigned to the NG arm of the study. 7 patients were assessed for eligibility of whom 2 withdrew from the study after one week in the NG arm and 5 refused to be randomized to the NG arm.

Conclusion: We concluded that NG tube placement is not an appropriate first-line option for prophylactic nutritional support among head and neck cancer patients at our center and should not be offered.