Normalcy of Food Intake in Head and Neck Cancer Patients Receiving (Chemo)Radiotherapy Supported by Swallowing Therapy and Individual Dietary Counselling. (Supportive Care)
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Neoplasms, Head and Neck
Both
Neoplasms, Head and Neck
Trial Information
Normalcy of Food Intake in Head and Neck Cancer Patients Receiving (Chemo)Radiotherapy Supported by Swallowing Therapy and Individual Dietary Counselling. (Supportive Care)
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Normalcy of food intake
Outcome Description:
Increase of "normalcy of food intake" of 10%
Outcome Time Frame:
within 6 months
Safety Issue:
No
Principal Investigator
Mattias A. W. Merkx, Prof. Dr.
Investigator Role:
Study Director
Investigator Affiliation:
Radboud University
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
FOCISD 01-03-2010
NCT ID:
NCT01110980
Start Date:
March 2010
Completion Date:
December 2012
Related Keywords:
- Neoplasms, Head and Neck
- Head and Neck neoplasms
- Radiotherapy
- Diet counselling
- Swallow therapy
- Food intake
- Neoplasms
- Head and Neck Neoplasms
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