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

Radboud University Medical Center

Status: Completed

Conditions: Neoplasms, Head and Neck

Treatments: Other: Individual dietary counselling; Other: Swallow therapy in combination with individual dietary counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT01110980

FOCISD 01-03-2010

Details and patient eligibility

About

• 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Swallowing therapy

Experimental group

Description:

Swallowing therapy in combination with individual dietary counselling

Treatment:

Other: Swallow therapy in combination with individual dietary counselling

Individual dietary counselling

Active Comparator group

Description:

Swallowing therapy only on indication. (usual care)

Treatment:

Other: Individual dietary counselling