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

Primary Purpose

Neoplasms, Head and Neck

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Swallow therapy in combination with individual dietary counselling
Individual dietary counselling
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neoplasms, Head and Neck focused on measuring Head and Neck neoplasms, Radiotherapy, Diet counselling, Swallow therapy, Food intake

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Radboud University Nijmegen Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Swallowing therapy

Individual dietary counselling

Arm Description

Swallowing therapy in combination with individual dietary counselling

Swallowing therapy only on indication. (usual care)

Outcomes

Primary Outcome Measures

Normalcy of food intake
Increase of "normalcy of food intake" of 10%

Secondary Outcome Measures

Quality of life

Full Information

First Posted
April 23, 2010
Last Updated
May 21, 2013
Sponsor
Radboud University Medical Center
Collaborators
Sorgente BV, Fresenius Kabi Nederland BV
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1. Study Identification

Unique Protocol Identification Number
NCT01110980
Brief Title
Normalcy of Food Intake in Head and Neck Cancer Patients
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Sorgente BV, Fresenius Kabi Nederland BV

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Head and Neck
Keywords
Head and Neck neoplasms, Radiotherapy, Diet counselling, Swallow therapy, Food intake

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Swallowing therapy
Arm Type
Experimental
Arm Description
Swallowing therapy in combination with individual dietary counselling
Arm Title
Individual dietary counselling
Arm Type
Active Comparator
Arm Description
Swallowing therapy only on indication. (usual care)
Intervention Type
Other
Intervention Name(s)
Swallow therapy in combination with individual dietary counselling
Other Intervention Name(s)
PST+IDC
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Individual dietary counselling
Other Intervention Name(s)
IDC
Intervention Description
Weekly Individual dietary counselling form the start of (chemo) radiotherapy until 6 months after last (chemo)radiation.
Primary Outcome Measure Information:
Title
Normalcy of food intake
Description
Increase of "normalcy of food intake" of 10%
Time Frame
within 6 months
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
within 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattias A. W. Merkx, Prof. Dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

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Normalcy of Food Intake in Head and Neck Cancer Patients

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