Normalcy of Food Intake in Head and Neck Cancer Patients (FOCISD)

Normalcy of Food Intake in Head and Neck Cancer Patients Receiving (Chemo)Radiotherapy Supported by Swallowing Therapy and Individual Dietary Counselling. (Supportive Care)

• 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.

Study Overview

• Status: Completed
• Conditions: Neoplasms, Head and Neck
• Intervention / Treatment: Other: Swallow therapy in combination with individual dietary counselling; Other: Individual dietary counselling

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboud University Nijmegen Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Swallowing therapy; Swallowing therapy in combination with individual dietary counselling	Other: Swallow therapy in combination with individual dietary counselling; Weekly swallowing therapy (by speech language therapist) from start of (chemo)radiation until 6 months after last (chemo)radiation. Weekly Individual dietary counselling (by dietician) form the start of (chemo) radiotherapy until 6 months after last (chemo)radiation. With close interaction between the both interventions.; Other Names: PST+IDC
Active Comparator: Individual dietary counselling; Swallowing therapy only on indication. (usual care)	Other: Individual dietary counselling; Weekly Individual dietary counselling form the start of (chemo) radiotherapy until 6 months after last (chemo)radiation.; Other Names: IDC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normalcy of food intake	Increase of "normalcy of food intake" of 10%	within 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life	within 6 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Sorgente BV; Fresenius Kabi Nederland BV
• Investigators: Study Director: Mattias A. W. Merkx, Prof. Dr., Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: April 26, 2010
• First Posted (Estimate): April 27, 2010

Study Record Updates

• Last Update Posted (Estimate): May 22, 2013
• Last Update Submitted That Met QC Criteria: May 21, 2013
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Radiotherapy; Food intake; Head and Neck neoplasms; Diet counselling; Swallow therapy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: FOCISD 01-03-2010