Normalcy of Food Intake in Head and Neck Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-12-31

Brief Summary

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* 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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Detailed Description

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Conditions

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Neoplasms, Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Swallowing therapy

Swallowing therapy in combination with individual dietary counselling

Group Type EXPERIMENTAL

Swallow therapy in combination with individual dietary counselling

Intervention Type 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.

Individual dietary counselling

Swallowing therapy only on indication. (usual care)

Group Type ACTIVE_COMPARATOR

Individual dietary counselling

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Individual dietary counselling

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

Intervention Type OTHER

Other Intervention Names

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PST+IDC IDC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No