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Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients With Head and Neck Cancer (HNC)

Primary Purpose

Head and Neck Neoplasm, Trismus, Deglutition Disorders

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Preventive intervention
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
  • Receiving radiohterpay (+/- chemotherapy) with curative intent
  • No previous trismus or dysphagia

Exclusion Criteria:

  • Surgery due to head and neck cancer
  • Previous treatment for head and neck cancer
  • Tracheostomized patients
  • No teeth
  • Inability to perform exercise intervention
  • Inability to independently fill out questionnaires in Swedish
  • Previous neurologic or neuromuscular disease

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Preventive intervention

Control group

Arm Description

Patient will perform daily exercise: jaw and swallwing exercises, as well as are encouraged to eat and drink for as long as possible during treatment

No intervention, only encouragement to eat and drink for as long as possible during treatment

Outcomes

Primary Outcome Measures

Maximal Interincisal opening (MIO)
Jaw opening measured in millimeters. A MIO <36 mm is considered as trismus. i.e. limited jaw-opening.
Swallowing ability
Swallowing ability measured with Functional Endoscopic Examination of Swallowing (FEES)

Secondary Outcome Measures

Trismus and jaw related symptoms
Patient Reported Outcomes (PRO) measured with Gothenburg Trismus Questionnaire (GTQ). The GTQ consists of 21 items divided into 3 domains; Jaw related problems, Eating limitations and Muscular tension and eight single items concerning facial pain, limitations in mouth opening and inabilities to function on social and working contexts. The GTQ domains range from 0-100 where 0 equals to absence of symtoms and 100 equals worst possible symptoms.
Dysphagia related symtoms
PRO measured with M.D Anderson Dysphagia Inventory (MDADI). This is a cancer-specific instrument measuring dysphagia, social function and quality of life in head and neck cancer patients. It consists of 19 items in four domains; emotional, physical, functional and global quality of life. The range for each subscale is 20-100 where 100 indicates best possible swallowing, i.e. better outcome.
Health related quality of life (HRQL)
Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core questionnaire (c30). Consists of 30 items divided into six functional domains (Physical, Role, Cognitive, Emotional, and Social Functioning and Global Quality of life), three symptom scales (Fatigue, Pain, and Nausea/Vomiting) and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). All domains range from 0-100. For the functional domains a higher score indicates good function, while for all other domains a high score indicates a high prevalence of symtoms, i.e. worse HRQL.
Health related quality of life (HRQL)
Measured with the EORTC QLQ Head and neck module (HN35). It consists of 35 questions regarding symptoms more specific to the head and neck cancer population, and domain scores range from 0-100, where a higher score represents the prevalence of more symtoms, i.e. worse HRQL.
Swallowing ability
Swallowing ability measured with FEES
Maximal Interincisal opening (MIO)
Jaw opening measured in millimeters

Full Information

First Posted
June 13, 2019
Last Updated
September 18, 2023
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT04005521
Brief Title
Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients With Head and Neck Cancer
Acronym
HNC
Official Title
Preventive Randomized Study Regarding Jaw- and Swallowing Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer: the Effect of Preventive Intervention for Trismus, Swallowing Function and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive jaw- and swallowing exercise protocol before and during radiotherapy) or a control group no performing a exercise protocol. All patients will be encouraged to eat or drink for as long as possible during the therapy. All patients will meet with a speech-language therapist weekly during radiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasm, Trismus, Deglutition Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preventive intervention
Arm Type
Experimental
Arm Description
Patient will perform daily exercise: jaw and swallwing exercises, as well as are encouraged to eat and drink for as long as possible during treatment
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention, only encouragement to eat and drink for as long as possible during treatment
Intervention Type
Behavioral
Intervention Name(s)
Preventive intervention
Intervention Description
Preventive, structured exercise protocol
Primary Outcome Measure Information:
Title
Maximal Interincisal opening (MIO)
Description
Jaw opening measured in millimeters. A MIO <36 mm is considered as trismus. i.e. limited jaw-opening.
Time Frame
1 month post radiotherapy
Title
Swallowing ability
Description
Swallowing ability measured with Functional Endoscopic Examination of Swallowing (FEES)
Time Frame
1 month after radiotherapy
Secondary Outcome Measure Information:
Title
Trismus and jaw related symptoms
Description
Patient Reported Outcomes (PRO) measured with Gothenburg Trismus Questionnaire (GTQ). The GTQ consists of 21 items divided into 3 domains; Jaw related problems, Eating limitations and Muscular tension and eight single items concerning facial pain, limitations in mouth opening and inabilities to function on social and working contexts. The GTQ domains range from 0-100 where 0 equals to absence of symtoms and 100 equals worst possible symptoms.
Time Frame
Up to 5 years post radiotherapy
Title
Dysphagia related symtoms
Description
PRO measured with M.D Anderson Dysphagia Inventory (MDADI). This is a cancer-specific instrument measuring dysphagia, social function and quality of life in head and neck cancer patients. It consists of 19 items in four domains; emotional, physical, functional and global quality of life. The range for each subscale is 20-100 where 100 indicates best possible swallowing, i.e. better outcome.
Time Frame
Up to 5 years post radiotherapy
Title
Health related quality of life (HRQL)
Description
Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core questionnaire (c30). Consists of 30 items divided into six functional domains (Physical, Role, Cognitive, Emotional, and Social Functioning and Global Quality of life), three symptom scales (Fatigue, Pain, and Nausea/Vomiting) and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). All domains range from 0-100. For the functional domains a higher score indicates good function, while for all other domains a high score indicates a high prevalence of symtoms, i.e. worse HRQL.
Time Frame
Up to 5 years post radiotherapy
Title
Health related quality of life (HRQL)
Description
Measured with the EORTC QLQ Head and neck module (HN35). It consists of 35 questions regarding symptoms more specific to the head and neck cancer population, and domain scores range from 0-100, where a higher score represents the prevalence of more symtoms, i.e. worse HRQL.
Time Frame
Up to 5 years post radiotherapy
Title
Swallowing ability
Description
Swallowing ability measured with FEES
Time Frame
Up to 5 years post radiotherapy
Title
Maximal Interincisal opening (MIO)
Description
Jaw opening measured in millimeters
Time Frame
Up to 5 years post radiotherapy
Other Pre-specified Outcome Measures:
Title
Cost
Description
The cost of intervention compared to usual care. Costs in Swedish crowns (SEK) for the intervention and all visits to healthcare during 5 years will be recorded.
Time Frame
Up to 5 years post radiotherapy
Title
Quality of life for cost-effectiveness analysis
Description
The outcomes of intervention compared to usual care using European Quality of life 5 dimensions (EQ5D).
Time Frame
Up to 5 years post radiotherapy
Title
Quality Adjusted Life Years (QALY)
Description
QALY is a measurement that combines health-related quality of life (HRQL) and life expectancy in one index. The index range between 0 and 1, where 0 equals death and 1 represents perfect health. Thus, 1 QALY corresponds to 1 year of perfect health. This is calculated using the EQ-5D.
Time Frame
Up to 5 years post radiotherapy
Title
Incremental Cost Effectiveness Ratio (ICER)
Description
Incremental cost for each QALY for the intervention group will be calculated using a Markov model which combines the costs and EQ-5D. The ICER will then be compared to the maximum willingness to pay level which is SEK 500,000 (€55,000) according to the Swedish National Board of Health and Welfare.
Time Frame
Up to 5 years post radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx) Receiving radiohterpay (+/- chemotherapy) with curative intent No previous trismus or dysphagia Exclusion Criteria: Surgery due to head and neck cancer Previous treatment for head and neck cancer Tracheostomized patients No teeth Inability to perform exercise intervention Inability to independently fill out questionnaires in Swedish Previous neurologic or neuromuscular disease
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

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Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients With Head and Neck Cancer

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