Prophylactic swallowing exercise program in head and neck cancer patients

Not Applicable

Completed

• Conditions: Head and neck cancer treated with radiotherapy or concomitant chemoradiotherapy; Cancer; Malignant neoplasm of head and neck treated with radiotherapy or concomitant chemoradiotherapy

• Registration Number: ISRCTN98243550
• Lead Sponsor: Antwerp University Hopsital

Brief Summary

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32122397 protocol (added 04/03/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36121560/ (added 20/09/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37550571/ Effect of service-delivery mode and overall adherence level (added 09/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-21
• Study Completion: 2022-06-30
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Newly diagnosed squamous cell carcinoma of the oropharynx
2. Stage III or IV cancer (according to TNM-7 classification)
3. Treatment with radiotherapy or concomitant chemoradiotherapy with/without induction chemotherapy
4. Demonstrating sufficient cognitive and language abilities

Exclusion Criteria

1. Recurrent carcinoma or metastasis from a non-HNC (head and neck cancer) carcinoma
2. Previous radiotherapy and/or chemoradiotherapy ,or surgery in head-neck region with possible impact on swallowing function

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 15/02/2019:<br>Swallowing function assessed , using the Mann Assessment of Swallowing Ability – Cancer (MASA-C) at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment<br><br>Previous primary outcome measure:<br>Degree of compliance, assessed weekly during the first 4 weeks of treatment, assessed using:<br>1. The total performed number of exercises per week, assessed by:<br>1.1. Daily patient (group 1 and group 2) and therapist (group 3) log book of performed exercises<br>1.2. IOPI device (group 2 and group 3) for tongue strengthening exercises<br>2. Time spent on the app per day (for group 2 only), automatically registered