Swallowing therapy and progressive resistance training in head and neck cancer patients undergoing radiotherapy treatment: randomized control trial protocol and preliminary data

Abstract

Background: Head and neck cancer (HNC) patients are often challenged by treatment induced dysphagia and trismus. Traditionally, rehabilitation is initiated when loss of function has already occurred. There is increasing evidence that it is of benefit to patients to initiate an early rehabilitation process before and during treatment. HNC patients have a unique set of functional challenges such as preand post-treatment dysphagia, pain and weight loss. The aim of the trial is to investigate the effects of swallowing and mouth-opening exercises combined with progressive resistance training (PRT) during radiotherapy. This report presents the protocol, interim inclusion and feasibility data. Material and methods: The trial (clinicaltrials.gov NCT02385929) is a multicenter randomized controlled trial (RCT) with a parallel-group randomization (1:1). The planned sample size of 240 HNC patients is randomly assigned to either (1) twice weekly PRT and three times weekly swallowing exercises by physio-and occupational therapists, respectively, as well as daily home exercises throughout radiotherapy or (2) standard care. Inclusion criteria are patients with cancer in the larynx, pharynx, oral cavity, or unknown primary tumor who are referred to radiotherapy with curative intent. Outcomes are measured at end-of-treatment and two, five, and 12 months post-treatment. Interim results: In 16 months, 321 HNC patients were screened for eligibility. Of these, 131 (41%) were eligible according to inclusion criteria. One-hundred-and-fifteen patients were invited to participate of which 69 (60%) were enrolled in the trial and randomized for either intervention or control group with 10 drop-outs (14%). The six pilot patients adhered more than 90% to the program. Conclusion: Preliminary results show that exercise according to protocol is tolerable and feasible.

Patient Adherence to Dysphagia Recommendations: A Systematic Review

“…(31, 32) One study(27) did not report an age range or mean. Including all studies that reported the age range and mean,(24–26, 28–30, 33) the collective age range for this review was 21–94, and the mean was 60.4 years.…”

“…Four studies(17, 25, 27, 34) completed retrospective studies earning a JAMA score of 3. Five studies(24, 26, 28, 30, 33) earned a JAMA quality rating score of 4 and used the following designs: prospective cohort,(24) case-series(26, 28, 33) and pilot study. (30)…”

“…Five studies(24, 26, 28, 30, 33) earned a JAMA quality rating score of 4 and used the following designs: prospective cohort,(24) case-series(26, 28, 33) and pilot study. (30)…”

“…Two methods were used to report adherence in the studies that qualified for inclusion in this review: 1) calculating an “ average adherence rate ” to recommendations using either actual observations of behavior or tallied exercise logs,(30, 32, 33) or 2) dividing participants into groups based on level of adherence, with each “adherence group” then expressed as a percentage of the total number of participants in the study. (17, 24–29, 31, 34) An example of “ grouped adherence ” reporting is found in a paper by Hutcheson and colleagues(25) where participants who performed exercises 4 or less times a day were considered “partially” adherent, and those who performed exercises 4 or more times a day were considered “fully” adherent.…”

“…The pooled adherence for the three studies(30, 32, 33) that calculated an “ average adherence rate ” was 51.3% (SD= 35.3%).…”