Prophylactic swallowing exercise program in head and neck cancer patients

Conditions

Head and neck cancer treated with radiotherapy or concomitant chemoradiotherapy Cancer Malignant neoplasm of head and neck treated with radiotherapy or concomitant chemoradiotherapy

Baudelet M, Van den Steen L, Duprez F, Goeleven A, Nuyts S, Nevens D, Vandenbruaene C, Massonet H, Vergauwen A, Vauterin T, Verstraete H, Wouters K, Vanderveken O, De Bodt M, Van Nuffelen G, members of the Belgian PRESTO-group.

2023-08-088 citations

10.1007/s00455-023-10609-7

Increasing Adherence to Prophylactic Swallowing Exercises During Head and Neck Radiotherapy: The Multicenter, Randomized Controlled PRESTO-Trial

Margot Baudelet, Fréderic Duprez, Leen Van den Steen, Sandra Nuyts, Daan Nevens et al. (26 authors)

Dysphagia2022-09-1918 citations

10.1007/s00455-022-10513-6

Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial).

Baudelet M, Van den Steen L, Duprez F, De Bodt M, Deschuymer S, Goeleven A, Hutsebaut I, Mariën S, Meersschout S, Nevens D, Nuyts S, Peeters M, Specenier P, Van den Brekel M, van der Molen L, Vandenbruaene C, Vanderveken O, Van Dinther J, Van Laer C, Vauterin T, Verstraete H, Van Nuffelen G, Member of the Belgian PRESTO Group.

2020-03-0221 citations

10.1186/s13063-020-4171-0

Interventions

Participants will be randomly allocated to one of three groups using the Qminim program. All participants will complete prophylactic swallowing exercises during the first 4 weeks of treatment. Group 1

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 15/02/2019: 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 Previous primary outcome measure: Degree of compliance, assessed weekly during the first 4 weeks of treatment, assessed using: 1. The total performed number of exercises per week, assessed by: 1.1. Daily patient (group 1 and group 2) and therapist (group 3) log book of performed exercises 1.2. IOPI device (group 2 and group 3) for tongue strengthening exercises 2. Time spent on the app per day (for group 2 only), automatically registered	—

Measure

Time frame

Current primary outcome measure as of 15/02/2019: 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 Previous primary outcome measure: Degree of compliance, assessed weekly during the first 4 weeks of treatment, assessed using: 1. The total performed number of exercises per week, assessed by: 1.1. Daily patient (group 1 and group 2) and therapist (group 3) log book of performed exercises 1.2. IOPI device (group 2 and group 3) for tongue strengthening exercises 2. Time spent on the app per day (for group 2 only), automatically registered

—

Secondary

Measure	Time frame
Current secondary outcome measures as of 15/02/2019: 1. Degree of compliance: assessed weekly during the first 4 weeks of treatment, using: 1.1. The total performed number of exercises per week, assessed by: 1.1.1. Daily patient (group 1 and group 2) and therapist (group 3) log book of performed exercises 1.1.2. IOPI device (group 2 and group 3) for tongue strengthening exercises 1.2. Time spent on the app per day (for group 2 only), automatically registered 2. Swallowing function: assessed at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment, using: 2.1. Eating Assessment Tool (EAT-10) 2.2. Self-perception of swallowing ability, assessed using a visual analogue scale ranging from 0 ("I can’t swallow at all") to 100 ("I can swallow perfectly") 2.3. Functional Oral Intake Scale 50 (FOIS) 3. Tongue strength, assessed using the Iowa Oral Performance Instrument (IOPI) to measure the maximum isometric tongue pressure at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment 4. Maximum muscle strength during Chin Tuck Against Resistance (CTAR), assessed using a dynamometer at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment 5. Quality of life: assessed at the baseline, at the end of treatment, and 1 and 3 months after treatment using: 5.1. Swallowing Quality of Life Questionnaire (SWAL-QoL) 5.2. Dysphagia Handicap Index (DHI) 6. Cost-effectiveness analysis regarding adherence to prophylactic swallowing exercises, assessed using the EQ-5D-5L at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment Previous secondary outcome measures: 1. Swallowing function, assessed at the baseline, after 6 weeks, at the end of treatment, and 1 and 3 months after treatment using: 1.1. Mann Assessment of Swallowing Ability--Cancer score (MASA-C) 1.2. Eating Assess	—

Measure

Time frame

Current secondary outcome measures as of 15/02/2019: 1. Degree of compliance: assessed weekly during the first 4 weeks of treatment, using: 1.1. The total performed number of exercises per week, assessed by: 1.1.1. Daily patient (group 1 and group 2) and therapist (group 3) log book of performed exercises 1.1.2. IOPI device (group 2 and group 3) for tongue strengthening exercises 1.2. Time spent on the app per day (for group 2 only), automatically registered 2. Swallowing function: assessed at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment, using: 2.1. Eating Assessment Tool (EAT-10) 2.2. Self-perception of swallowing ability, assessed using a visual analogue scale ranging from 0 ("I can’t swallow at all") to 100 ("I can swallow perfectly") 2.3. Functional Oral Intake Scale 50 (FOIS) 3. Tongue strength, assessed using the Iowa Oral Performance Instrument (IOPI) to measure the maximum isometric tongue pressure at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment 4. Maximum muscle strength during Chin Tuck Against Resistance (CTAR), assessed using a dynamometer at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment 5. Quality of life: assessed at the baseline, at the end of treatment, and 1 and 3 months after treatment using: 5.1. Swallowing Quality of Life Questionnaire (SWAL-QoL) 5.2. Dysphagia Handicap Index (DHI) 6. Cost-effectiveness analysis regarding adherence to prophylactic swallowing exercises, assessed using the EQ-5D-5L at baseline, during the first 4 weeks of treatment, at the end of treatment, and 1 and 3 months after treatment Previous secondary outcome measures: 1. Swallowing function, assessed at the baseline, after 6 weeks, at the end of treatment, and 1 and 3 months after treatment using: 1.1. Mann Assessment of Swallowing Ability--Cancer score (MASA-C) 1.2. Eating Assess

—

Countries

Belgium, Netherlands

Contacts

Public ContactGwen Van Nuffelen

gwen.vannuffelen@uza.be+3238213441

Outcome results

None listed