Radiation therapy is curative for many head and neck cancers but can result in dysphagia that decreases patients’ quality of life and puts them at risk of malnutrition and pneumonia. Although concurrent swallowing therapy during radiation therapy to the neck can help patients avoid or decrease the impact of dysphagia, the optimal approach to swallowing therapy remains unknown. To determine the appropriate timing and intensity of swallowing therapy, researchers at The University of Texas MD Anderson Cancer Center are leading a multicenter randomized trial.
“We have data from small, single-site trials and retrospective studies showing that high-intensity swallowing therapy helps patients maintain their ability to swallow during radiation therapy to the neck,” said Kate Hutcheson, Ph.D., an associate professor in the Department of Head and Neck Surgery and the associate director of research for the Section of Speech Pathology and Audiology. “However, a recent Cochrane review was unable to identify best practice in this area, citing the lack of sufficiently powered randomized clinical trials.”
To gather data for establishing swallowing therapy guidelines, Dr. Hutcheson and her colleagues designed a randomized clinical trial that compares reactive swallowing therapy (i.e., therapy given after the patient develops dysphagia) with two proactive approaches of different intensities. The trial, named PRO-ACTIVE (No. NCT03455608), recently began enrolling patients who plan to undergo radiation therapy with curative intent for head and neck cancer.
The PRO-ACTIVE trial is open to patients who will receive radiation therapy to both sides of the neck to a total dose of at least 60 Gy over 6–7 weeks. Patients with dysphagia at enrollment are excluded. At enrollment, each patient is randomly assigned to the reactive, low-intensity proactive, or high-intensity proactive treatment arm.
Patients in the reactive treatment arm do not initially undergo swallowing therapy. Their symptoms are monitored throughout their radiation therapy by a weekly questionnaire, and those who develop symptoms of swallowing difficulties, such as a tendency to choke on food and liquids, or who become dependent on feeding tubes begin to receive high-intensity swallowing therapy when their symptoms arise.
Patients in the low-intensity proactive treatment arm see a speech pathologist at the beginning of radiation therapy and every 2 weeks thereafter. The speech pathologist teaches the patients a mealtime routine that promotes maintenance of safe and challenging food intake during radiation therapy. This swallowing therapy regimen is based on the premise that keeping muscles active by eating can preserve their function. The speech pathologist also teaches patients to think of food as having different levels of swallowing challenges, with each of those challenges representing a step on a staircase. “The goal is to keep patients as high as possible on the staircase for as long as possible during radiation therapy,” Dr. Hutcheson said.
Patients in the high-intensity treatment arm follow the same regimen as those in the low-intensity treatment arm but also perform daily swallowing exercises designed to strengthen the muscles used to swallow. This regimen is similar to that used in MD Anderson’s preventive swallowing therapy program (see Swallowing Therapy for Head and Neck Cancer Patients, OncoLog, February 2016).
The effectiveness of each treatment approach will be determined by assessing patients’ duration of dependence on feeding tubes, swallowing strength as measured by videofluoroscopy, and scores on symptom and quality-of-life questionnaires. “We hypothesize that the high-intensity proactive treatment will have the best results, but it could be that we find that one of the lower-burden, lower-resource treatments offers patients a less demanding way to maintain their ability to swallow,” Dr. Hutcheson said.
The PRO-ACTIVE trial is enrolling patients at multiple centers in the United States and Canada. In the Houston area, the trial is open to patients at MD Anderson’s main campus in the Texas Medical Center as well as its Sugar Land, Bay Area, and Katy locations.
“In the past, patients who received radiation therapy at our other locations around Houston had to come to the main campus if they needed swallowing therapy,” Dr. Hutcheson said. “But now, in addition to providing swallowing therapy, those locations are slated to roll out additional speech pathology services for our head and neck cancer patients.”