Normalcy of Food Intake in Head and Neck Cancer Patients

Neoplasms, Head and Neck Clinical Trial

— FOCISD  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110980
• Other study ID #: FOCISD 01-03-2010
• Status: Completed
• Phase: N/A
• First received: April 23, 2010
• Last updated: May 21, 2013
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Neoplasms, Head and Neck

Intervention

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.
• Individual dietary counselling
Weekly Individual dietary counselling form the start of (chemo) radiotherapy until 6 months after last (chemo)radiation.

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University	Fresenius Kabi Nederland BV, Sorgente BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalcy of food intake	Increase of "normalcy of food intake" of 10%	within 6 months	No
Secondary	Quality of life		within 6 months	No