OBJECTIVE: To assess the efficacy of prophylactic swallowing exercises on swallowing function in patients undergoing chemoradiation therapy (CRT) for head and neck cancer. DESIGN: Randomized controlled trial. SETTING: Tertiary care, academic medical center. PATIENTS: Twenty-six patients with head and neck cancer receiving CRT. INTERVENTION: Patients performed 5 targeted swallowing exercises throughout their CRT and participated in weekly swallowing therapy sessions to promote adherence and accurate technique. Controls had no prophylactic exercises and were referred for swallowing treatment after completion of CRT if indicated. MAIN OUTCOME MEASURES: Swallowing function was assessed with the Functional Oral Intake Scale (FOIS) and the Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) at baseline, immediately after CRT, and at 3, 6, 9, and 12 months after CRT. RESULTS: There were no statistically significant differences in FOIS scores between intervention and control patients immediately after CRT (immediately after CRT: intervention group median score, 3 [range, 1-7], vs median control score, 4 [range, 1-6] (P = .88). However, intervention patients had significantly better scores at months 3 and 6 (median 3-month intervention score, 7 [range, 5-7], vs median control score, 5 [range, 3-7] [P = .03]; median 6-month intervention score, 7 [range, 6-7], vs median control score, 6 [range, 3-7] [P = .009]). There was no significant difference in scores at months 9 and 12 (P = .24 and P = .93, respectively). The same pattern between intervention and control patients was observed for scores on the PSS-H&N. CONCLUSIONS: Patients who performed prophylactic swallowing exercises had improved swallowing function at 3 and 6 months after CRT but not immediately after CRT or at 9 and 12 months after CRT. The small sample size may have limited our ability to detect significant differences beyond 6 months of observation as well as additional significant differences in our study.
RCT Entities:
OBJECTIVE: To assess the efficacy of prophylactic swallowing exercises on swallowing function in patients undergoing chemoradiation therapy (CRT) for head and neck cancer. DESIGN: Randomized controlled trial. SETTING: Tertiary care, academic medical center. PATIENTS: Twenty-six patients with head and neck cancer receiving CRT. INTERVENTION: Patients performed 5 targeted swallowing exercises throughout their CRT and participated in weekly swallowing therapy sessions to promote adherence and accurate technique. Controls had no prophylactic exercises and were referred for swallowing treatment after completion of CRT if indicated. MAIN OUTCOME MEASURES: Swallowing function was assessed with the Functional Oral Intake Scale (FOIS) and the Performance Status Scale for Head and Neck CancerPatients (PSS-H&N) at baseline, immediately after CRT, and at 3, 6, 9, and 12 months after CRT. RESULTS: There were no statistically significant differences in FOIS scores between intervention and control patients immediately after CRT (immediately after CRT: intervention group median score, 3 [range, 1-7], vs median control score, 4 [range, 1-6] (P = .88). However, intervention patients had significantly better scores at months 3 and 6 (median 3-month intervention score, 7 [range, 5-7], vs median control score, 5 [range, 3-7] [P = .03]; median 6-month intervention score, 7 [range, 6-7], vs median control score, 6 [range, 3-7] [P = .009]). There was no significant difference in scores at months 9 and 12 (P = .24 and P = .93, respectively). The same pattern between intervention and control patients was observed for scores on the PSS-H&N. CONCLUSIONS:Patients who performed prophylactic swallowing exercises had improved swallowing function at 3 and 6 months after CRT but not immediately after CRT or at 9 and 12 months after CRT. The small sample size may have limited our ability to detect significant differences beyond 6 months of observation as well as additional significant differences in our study.
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