Of the many sequelae following head and neck surgery, one of the most devastating is the resulting post operative dysphagia. In an effort to ameliorate this difficulty, many head and neck surgeons have incorporated cricopharyngeal myotomies as part of their oncologic procedure. Data supporting the incorporation of this procedure must be regarded as limited. This prospective randomized trial will specifically evaluate the role, if any, of cricopharyngeal myotomy in the treatment of dysphagia resulting from major head and neck oncologic surgery. The population studied will be 400 head and neck cancer patients scheduled for surgery involving resection of one or more of the following structures: arytenoid, supraglottic larynx, tongue base to circumvellae papilla, or hypopharynx. This patient population was selected for this study in anticipation of a high incidence of postoperative dysphagia. The patients will be enrolled through the auspices of the Radiation Therapy Oncology Group (RTOG). The RTOG is a multi-institutional study group with a long history of conducting successful trials in the head and neck cancer patient population. The preliminary evaluation tool will be video- fluoroscopic examination of swallowing which will be obtained pre-operatively, within 3 days following completion of healing, 3 months and 6 months post-healing. Central review and data reduction of the tapes will be utilized to ensure quality and uniformity of data. The primary end point to be utilized to evaluate the effectiveness of the addition of cricopharyngeal myotomy in conjunction with complete tumor resection is the frequency of patients with normal swallowing function six months post-surgical healing. A patient will be considered to have normal swallowing function if the sum of the oral and pharyngeal transit times during all swallows of liquid, paste, and cookie is less than 2.0 seconds without any signs of aspiration, dry swallows, or coughing.
| Baines, Antonio; Taylor-Parker, Michele; Goulet, Anne-Christine et al. (2002) Selenomethionine inhibits growth and suppresses cyclooxygenase-2 (COX-2) protein expression in human colon cancer cell lines. Cancer Biol Ther 1:370-4 |
| Jacobs, J R; Logemann, J; Pajak, T F et al. (1999) Failure of cricopharyngeal myotomy to improve dysphagia following head and neck cancer surgery. Arch Otolaryngol Head Neck Surg 125:942-6 |
