Normalcy of Food Intake in Head and Neck Cancer Patients (FOCISD)
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|ClinicalTrials.gov Identifier: NCT01110980|
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : May 22, 2013
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.
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 or disease||Intervention/treatment||Phase|
|Neoplasms, Head and Neck||Other: Swallow therapy in combination with individual dietary counselling Other: Individual dietary counselling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|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)|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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
- Normalcy of food intake [ Time Frame: within 6 months ]Increase of "normalcy of food intake" of 10%
- Quality of life [ Time Frame: within 6 months ]
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
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Study Director:||Mattias A. W. Merkx, Prof. Dr.||Radboud University|