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

This study has been completed.
Sponsor:
Collaborators:
Sorgente BV
Fresenius Kabi Nederland BV
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01110980
First received: April 23, 2010
Last updated: May 21, 2013
Last verified: October 2012

April 23, 2010
May 21, 2013
March 2010
December 2012   (final data collection date for primary outcome measure)
Normalcy of food intake [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
Increase of "normalcy of food intake" of 10%
Same as current
Complete list of historical versions of study NCT01110980 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Normalcy of Food Intake in Head and Neck Cancer Patients
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Neoplasms, Head and Neck
  • 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
  • Other: Individual dietary counselling
    Weekly Individual dietary counselling form the start of (chemo) radiotherapy until 6 months after last (chemo)radiation.
    Other Name: IDC
  • Experimental: Swallowing therapy
    Swallowing therapy in combination with individual dietary counselling
    Intervention: Other: Swallow therapy in combination with individual dietary counselling
  • Active Comparator: Individual dietary counselling
    Swallowing therapy only on indication. (usual care)
    Intervention: Other: Individual dietary counselling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01110980
FOCISD 01-03-2010
No
Radboud University
Radboud University
  • Sorgente BV
  • Fresenius Kabi Nederland BV
Study Director: Mattias A. W. Merkx, Prof. Dr. Radboud University
Radboud University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP