Normalcy of Food Intake in Head and Neck Cancer Patients

Normalcy of Food Intake in Head and Neck Cancer Patients Receiving (Chemo)Radiotherapy Supported by Swallowing Therapy and Individual Dietary Counselling. (Supportive Care)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01110980

Acronym

FOCISD

Enrollment

120

Registered

2010-04-27

Start date

2010-03-31

Completion date

2012-12-31

Last updated

2013-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Head and Neck

Keywords

Head and Neck neoplasms, Radiotherapy, Diet counselling, Swallow therapy, Food intake

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.

Interventions

OTHERSwallow 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.

OTHERIndividual dietary counselling

Weekly Individual dietary counselling form the start of (chemo) radiotherapy until 6 months after last (chemo)radiation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Normalcy of food intake	within 6 months	Increase of normalcy of food intake of 10%

Secondary

Measure	Time frame
Quality of life	within 6 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026