Normalcy of Food Intake in Head and Neck Cancer Patients

Not Applicable

Completed

• Conditions: Neoplasms, Head and Neck
• Interventions: Other: Individual dietary counselling; Other: Swallow therapy in combination with individual dietary counselling

• Registration Number: NCT01110980
• Lead Sponsor: Radboud University Medical Center

Brief Summary

* 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Status Verified: 2012-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2013-05-21
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual dietary counselling	Individual dietary counselling	Swallowing therapy only on indication. (usual care)
Swallowing therapy	Swallow therapy in combination with individual dietary counselling	Swallowing therapy in combination with individual dietary counselling

Primary Outcome Measures

Name	Time	Method
Normalcy of food intake	within 6 months	Increase of "normalcy of food intake" of 10%

Secondary Outcome Measures

Name	Time	Method
Quality of life	within 6 months

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands