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出境医 / 临床实验 / Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients With Head and Neck Cancer (HNC)

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

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasm Trismus Deglutition Disorders Behavioral: Preventive intervention Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : December 31, 2035
Arms and Interventions
Arm Intervention/treatment
Experimental: Preventive intervention
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
 Behavioral: Preventive intervention
Preventive, structured exercise protocol
No Intervention: Control group
No intervention, only encouragement to eat and drink for as long as possible during treatment
Outcome Measures
Primary Outcome Measures :
  1. Maximal Interincisal opening (MIO) [ Time Frame: 1 month post radiotherapy ]
    Jaw opening measured in millimeters. A MIO <36 mm is considered as trismus. i.e. limited jaw-opening.

  2. Swallowing ability [ Time Frame: 1 month after radiotherapy ]
    Swallowing ability measured with Functional Endoscopic Examination of Swallowing (FEES)


Secondary Outcome Measures :
  1. Trismus and jaw related symptoms [ Time Frame: Up to 5 years post radiotherapy ]
    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.

  2. Dysphagia related symtoms [ Time Frame: Up to 5 years post radiotherapy ]
    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.

  3. Health related quality of life (HRQL) [ Time Frame: Up to 5 years post radiotherapy ]
    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.

  4. Health related quality of life (HRQL) [ Time Frame: Up to 5 years post radiotherapy ]
    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.

  5. Swallowing ability [ Time Frame: Up to 5 years post radiotherapy ]
    Swallowing ability measured with FEES

  6. Maximal Interincisal opening (MIO) [ Time Frame: Up to 5 years post radiotherapy ]
    Jaw opening measured in millimeters


Other Outcome Measures:
  1. Cost [ Time Frame: Up to 5 years post radiotherapy ]
    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.

  2. Quality of life for cost-effectiveness analysis [ Time Frame: Up to 5 years post radiotherapy ]
    The outcomes of intervention compared to usual care using European Quality of life 5 dimensions (EQ5D).

  3. Quality Adjusted Life Years (QALY) [ Time Frame: Up to 5 years post radiotherapy ]
    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.

  4. Incremental Cost Effectiveness Ratio (ICER) [ Time Frame: Up to 5 years post radiotherapy ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Lisa Tuomi, PhD +46313422543 lisa.tuomi@vgregion.se

Locations
Layout table for location information
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 41345
Contact: Lisa Tuomi         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE June 13, 2019
Estimated Primary Completion Date July 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Maximal Interincisal opening (MIO) [ Time Frame: 1 month post radiotherapy ]
    Jaw opening measured in millimeters. A MIO <36 mm is considered as trismus. i.e. limited jaw-opening.
  • Swallowing ability [ Time Frame: 1 month after radiotherapy ]
    Swallowing ability measured with Functional Endoscopic Examination of Swallowing (FEES)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Trismus and jaw related symptoms [ Time Frame: Up to 5 years post radiotherapy ]
    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 [ Time Frame: Up to 5 years post radiotherapy ]
    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) [ Time Frame: Up to 5 years post radiotherapy ]
    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) [ Time Frame: Up to 5 years post radiotherapy ]
    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 [ Time Frame: Up to 5 years post radiotherapy ]
    Swallowing ability measured with FEES
  • Maximal Interincisal opening (MIO) [ Time Frame: Up to 5 years post radiotherapy ]
    Jaw opening measured in millimeters
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 1, 2019)
  • Cost [ Time Frame: Up to 5 years post radiotherapy ]
    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.
  • Quality of life for cost-effectiveness analysis [ Time Frame: Up to 5 years post radiotherapy ]
    The outcomes of intervention compared to usual care using European Quality of life 5 dimensions (EQ5D).
  • Quality Adjusted Life Years (QALY) [ Time Frame: Up to 5 years post radiotherapy ]
    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.
  • Incremental Cost Effectiveness Ratio (ICER) [ Time Frame: Up to 5 years post radiotherapy ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients With Head and Neck Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Head and Neck Neoplasm
  • Trismus
  • Deglutition Disorders
Intervention  ICMJE Behavioral: Preventive intervention
Preventive, structured exercise protocol
Study Arms  ICMJE
  • Experimental: Preventive intervention
    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
    Intervention: Behavioral: Preventive intervention
  • No Intervention: Control group
    No intervention, only encouragement to eat and drink for as long as possible during treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2035
Estimated Primary Completion Date July 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisa Tuomi, PhD +46313422543 lisa.tuomi@vgregion.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005521
Other Study ID Numbers  ICMJE 00
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lisa Tuomi, Sahlgrenska University Hospital, Sweden
Study Sponsor  ICMJE Sahlgrenska University Hospital, Sweden
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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