NCT01110980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 22, 2013

Status Verified

October 1, 2012

Enrollment Period

2.8 years

First QC Date

April 23, 2010

Last Update Submit

May 21, 2013

Conditions

Neoplasms, Head and Neck

Keywords

Head and Neck neoplasmsRadiotherapyDiet counsellingSwallow therapyFood intake

Outcome Measures

Primary Outcomes (1)

  • Normalcy of food intake

    Increase of "normalcy of food intake" of 10%

    within 6 months

Secondary Outcomes (1)

  • Quality of life

    within 6 months

Study Arms (2)

Swallowing therapy

EXPERIMENTAL

Swallowing therapy in combination with individual dietary counselling

Other: Swallow therapy in combination with individual dietary counselling

Individual dietary counselling

ACTIVE COMPARATOR

Swallowing therapy only on indication. (usual care)

Other: Individual dietary counselling

Interventions

Swallow therapy in combination with individual dietary counsellingOTHER

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.

Also known as: PST+IDC
Swallowing therapy
Individual dietary counsellingOTHER

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

Also known as: IDC
Individual dietary counselling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Mattias A. W. Merkx, Prof. Dr.

    Radboud University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2010

First Posted

April 27, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 22, 2013

Record last verified: 2012-10

Locations

NL(1)