Clinical trial · Interventional
Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): For financial reasons and speed of recruitment was much slower than expected, inclusions weren't resumed after it was suspended during COVID-19 confinment.
Summary
Brief summary (as posted)
Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation indications have risen over the last decade, leading to a significant loss of quality of life for patients. Recently, many retrospective studies and two evidence-based and systematic reviews on strategies to reduce radiation-induced dysphagia have suggested a trend toward benefit for a preventive swallowing exercise program. The main hypothesis of this study is that an early active swallowing therapy can improve the Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer. The study will be a randomized controlled, open-label, multicentric phase III clinical trial comparing early active swallowing therapy versus non specific swallowing management (usual care).
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 |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Swallowing therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early active swallowing therapy
- interventionNames
- Other: Swallowing therapy
- type
- NO_INTERVENTION
- label
- Usual care
Primary outcomes (1)
- measure
- Proportion of patients experiencing a clinically relevant improvement defined as a decrease of at least 10 points of the score HNSW ( 6 months after radiotherapy compared with the score before radiotherapy
- timeFrame
- 6 months after radiotherapy
- description
- HNSW = Head and Neck Swallowing Questionnaire
Secondary outcomes (13)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient treated for histologically proven head and neck cancer (oral cavity, oropharynx, or hypopharynx cancer) of stages I-IV or larynx cancer of stages II-IV, all histologic type, without distant metastasis * Indication of curative radiotherapy alone or associated to chemotherapy or targeted therapy, without planned surgery * WHO (World Health Organization) Performance Status 0, 1 or 2 * Sufficient cognitive capacities to complete a QoL questionnaire (evaluation by the physician at inclusion) * Written informed consent * Patients with health insurance Exclusion Criteria: * Previous radiotherapy or surgery of the upper aerodigestive tract * Cancer of paranasal sinuses or nasopharynx or skull base * Medical history of nervous system disease associated to significant sequelae in terms of dysphagia * Pregnant or breast-feeding woman * Patient under guardianship, trusteeship or judicial protection
References
Publications (0)
Data not yet available