Clinical trial · Interventional
Normalcy of Food Intake in Head and Neck Cancer Patients
Normalcy of Food Intake in Head and Neck Cancer Patients Receiving (Chemo)Radiotherapy Supported by Swallowing Therapy and Individual Dietary Counselling. (Supportive Care)
- 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)
* Background: Oral nutrition appears to be a challenge for patients with head and neck cancer after radiotherapy. Many patients desire to (their) 'normal food intake' and return to oral nutrition with normal consistency without modifications and diet formulas. Due to the dysphagia experienced post treatment this seems tremendously difficult. Referral to a speech-language therapist for swallowing therapy is no standard procedure. * Study design: A prospective randomized study in patients with a tumor in Oral cavity, Nasopharynx, Oropharynx, Hypopharynx or Larynx with stage II-IV (UICC TNM-tumor classification), ≥ 18 years, eligible for primary treatment with (chemo)radiation or adjuvant radiotherapy with curative intent. * Intervention: Individually tailored swallowing therapy by an experienced speech-language therapist in cooperation with individual dietary counselling (by an experienced dietician, 'usual care') pre-, per- and post treatment (until 6 months after treatment). This might improve 'normalcy of food intake', quality (no food modifications) and quantity of food intake and besides decrease the use of tube feeding and/or nutritional supplements. Also patients quality of life and nutritional status may be influenced positively. * Study hypothesis: The purpose of this study is to determine whether combined individual swallowing therapy and individual dietary counselling in patients with head and neck cancer receiving (chemo)radiotherapy can improve 'normal food intake'. Food intake without modifications and tube feeding and/or nutritional supplements.
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 |
|---|---|---|---|
| Neoplasms, Head and Neck | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individual dietary counselling | Other | — | UNRESOLVED |
| Swallow therapy in combination with individual dietary counselling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Swallowing therapy
- description
- Swallowing therapy in combination with individual dietary counselling
- interventionNames
- Other: Swallow therapy in combination with individual dietary counselling
- type
- ACTIVE_COMPARATOR
- label
- Individual dietary counselling
- description
- Swallowing therapy only on indication. (usual care)
- interventionNames
- Other: Individual dietary counselling
Primary outcomes (1)
- measure
- Normalcy of food intake
- timeFrame
- within 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with tumor in oral cavity, nasopharynx, hypopharynx or larynx with stage II-IV (UICC TNM-tumor classification) * Eligible for primary curative treatment intentions with (chemo)radiation or adjuvant (chemo)radiotherapy * A signed informed consent Exclusion Criteria: * Historical swallowing problems (neurological or not tumor related) * Unable to comprehend and carry out the swallowing rehabilitation * Unable to answer study questions * Radiation or surgery for head and neck cancer in history.
References
Publications (0)
Data not yet available