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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    Increase of "normalcy of food intake" of 10%


Secondary Outcome Measures:
  • Quality of life [ Time Frame: within 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01110980     History of Changes
Other Study ID Numbers: FOCISD 01-03-2010
Study First Received: April 23, 2010
Last Updated: May 21, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on September 18, 2014