Clinical trial · Interventional
Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer
Randomized Phase II Trial: Swallowing Speech Pathology Intervention During Radiochemotherapy on Patients With Head and Neck Cancer
- 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)
General Objective: To evaluate the swallowing results of speech pathologist rehabilitation of advanced oropharynges, larynx and hypopharynx cancer patients during neoadjuvant chemotherapy and radiotherapy concomitant to chemotherapy. Methods and Casuistic: Randomized clinical trial phase II. 80 patients with advanced oropharynges, larynx and hypopharynx cancer diagnoses from Barretos Cancer Hospital, which had the proposal of neoadjuvant chemotherapy followed by radiotherapy combined with chemotherapy. Patients are randomized on two groups: control group and speech pathology therapy group
Conditions
Conditions (2)
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 Neck Cancer | — | UNRESOLVED | — |
| Swallowing Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pre, during and pos-treatment swallowing exercises | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Speech pathology therapy
- description
- Pre, during and pos-treatment swallowing exercises.
- interventionNames
- Procedure: pre, during and pos-treatment swallowing exercises
- type
- NO_INTERVENTION
- label
- Control group
- description
- These patients will not receive speech pathology therapy.
Primary outcomes (1)
- measure
- Swallowing function
- timeFrame
- up to 6 months after concurrent phase.
- description
- Self-reporting swallowing questionnaire, clinical swallowing examination and modified barium swallow (MBS), and the MD Anderson Dysphagia Inventory (MDADI).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Head and neck squamous cell carcinoma * Indication for the protocol treatment of neoadjuvant chemotherapy followed by radiotherapy concomitant to chemotherapy. * Oropharynges, larynx and hypopharynx advanced cancer (T3 or T4), classified as resectable; * 18 years old or older; * informed consent signed before any specific procedure Exclusion Criteria: * Previous head and neck surgery * Previous radiotherapy or chemotherapy * Previous history of neoplasia, excepted for in situ carcinoma of endometrial (uterine) cancer, skin basal cell or squamous cell carcinoma; * Severe laryngeal aspiration during all consistencies swallowing evaluated thought videofluoroscopy * Patients with cognitive deficit which could not comprehend the speech pathology intervention.
References
Publications (0)
Data not yet available