Clinical trial · Interventional
Pre-habilitation of Patients With Head and Neck Cancer
Bimodal Pre-habilitation Program to Improve Symptom Control After Treatment for Head and Neck Cancer
NCT02385929CI-TRIAL-00044300SYNKcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to explore whether early initiated physical exercise concurrent with a swallowing and mouth opening exercise program will have a positive effect on swallowing function and other quality of life aspects in patients treated with radiotherapy for head and neck cancer. The investigators hypothesize that patients who complete the program will have improved swallowing function and physical function one year after completing their treatment compared to patients who do not participate in the training program.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Swallowing therapy & resistance training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Swallowing therapy & resistance training
- description
- Mouth opening and swallowing exercise intervention by occupational therapist for half an hour 3 times a week for 5-6 weeks during radiotherapy. Progressive resistance training by physiotherapist for 1 hour twice weekly for 5-6 weeks during radiotherapy.
- interventionNames
- Behavioral: Swallowing therapy & resistance training
- type
- NO_INTERVENTION
- label
- Standard Care
- description
- Patients in this arm are randomized to usual care / control group
Primary outcomes (1)
- measure
- Swallowing function measured by penetration aspiration scale (PAS) during a Fiber Endoscopic Evaluation of Swallowing (FEES).
- timeFrame
- Baseline, 14 weeks and 58 weeks. Participants will be followed up till 12 months after they finalize their radiotherapy, an expected average of 58 weeks from baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proven cancer in one or more of the following areas: larynx, hypopharynx, oropharynx, cavi oris, or unknown primary tumor * Set to curative radiotherapy with or without concurrent chemotherapy for treatment of cancer in the head and neck region in accordance with the Danish Head and Neck Cancer Group (DAHANCA) guidelines * Fully self-reliant * Danish skills, oral and written * Informed consent Exclusion Criteria: * Previously received treatment for head and neck cancer (radiotherapy, chemotherapy and/or surgery). * Pregnancy * ECOG performance status \> 2 * Presence of psychological-, family-, sociological- or geographical issues that could prevent the patient from completing the intervention * Simultaneous or previous illness or conditions that could prevent the patient's ability to complete the intervention.
References
Publications (4)
- BACKGROUNDHajdu SF, Wessel I, Johansen C, Kristensen CA, Kadkhoda ZT, Plaschke CC, Dalton SO. Swallowing therapy and progressive resistance training in head and neck cancer patients undergoing radiotherapy treatment: randomized control trial protocol and preliminary data. Acta Oncol. 2017 Feb;56(2):354-359. doi: 10.1080/0284186X.2016.1269193. PMID 28206871
- BACKGROUNDHajdu SF, Plaschke CC, Johansen C, Dalton SO, Wessel I. Cross-Cultural Translation, Adaptation and Reliability of the Danish M. D. Andeson Dysphagia Inventory (MDADI) in Patients with Head and Neck Cancer. Dysphagia. 2017 Aug;32(4):472-479. doi: 10.1007/s00455-017-9785-3. Epub 2017 Mar 7. PMID 28271296
- BACKGROUNDFredslund SV, Hogdal N, Christensen MB, Wessel I. Dysphagia training after head and neck cancer fails to follow legislation and national recommendations. Dan Med J. 2015 May;62(5):A5067. PMID 26050828
- DERIVEDHajdu SF, Christensen MB, Kristensen MO, Wessel I, Johansen C, Dalton S. Adherence to preventive swallowing exercises for head and neck cancer patients undergoing (chemo)radiotherapy treatment. Acta Oncol. 2019 May;58(5):658-664. doi: 10.1080/0284186X.2018.1563715. Epub 2019 Jan 30. PMID 30698049