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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01110980
First Posted: April 27, 2010
Last Update Posted: May 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Sorgente BV
Fresenius Kabi Nederland BV
Information provided by (Responsible Party):
Radboud University
  Purpose
  • 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.


Condition Intervention
Neoplasms, Head and Neck Other: Swallow therapy in combination with individual dietary counselling Other: Individual dietary counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Normalcy of food intake [ Time Frame: within 6 months ]
    Increase of "normalcy of food intake" of 10%


Secondary Outcome Measures:
  • Quality of life [ Time Frame: within 6 months ]

Enrollment: 120
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: IDC

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110980


Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Sorgente BV
Fresenius Kabi Nederland BV
Investigators
Study Director: Mattias A. W. Merkx, Prof. Dr. Radboud University
  More Information

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01110980     History of Changes
Other Study ID Numbers: FOCISD 01-03-2010
First Submitted: April 23, 2010
First Posted: April 27, 2010
Last Update Posted: May 22, 2013
Last Verified: October 2012

Keywords provided by Radboud University:
Head and Neck neoplasms
Radiotherapy
Diet counselling
Swallow therapy
Food intake

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms