Clinical trial NCT01110980: Normalcy of Food Intake in Head and Neck Cancer Patients
Official title: Normalcy of Food Intake in Head and Neck Cancer Patients Receiving (Chemo)Radiotherapy Supported by Swallowing Therapy and Individual Dietary Counselling. (Supportive Care)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms, Head and Neck
Keywords: Head and Neck neoplasms
Radiotherapy
Diet counselling
Swallow therapy
Food intake
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Sorgente BV
name: Fresenius Kabi Nederland BV
First posted: 2010-04-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Normalcy of food intake
timeFrame: within 6 months
Secondary outcomes:
measure: Quality of life
timeFrame: within 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Mattias A. W. Merkx, Prof. Dr.
role: STUDY_DIRECTOR
References: