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OpenTrials
Completed

NCT Number: NCT01110980

Normalcy of Food Intake in Head and Neck Cancer Patients

* 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Swallow therapy in combination with individual dietary counselling

Other

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 names: PST+IDC

individual dietary counselling

Other

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

Other names: IDC

Primary outcomes

  1. Normalcy of food intake

    Time frame: within 6 months

    Increase of "normalcy of food intake" of 10%

Secondary outcomes

  1. Quality of life

    Time frame: within 6 months

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Fresenius Kabi Nederland BV
  • Sorgente BV

Registry information

Official study title

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

Acronym: FOCISD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 27, 2010
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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