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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05432297
Other study ID # 01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2023
Est. completion date December 2031

Study information

Verified date September 2023
Source Sahlgrenska University Hospital, Sweden
Contact Lisa Tuomi, PhD
Phone +46313421000
Email tuomi.lisa@gu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2031
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx) - Receiving radiohterapy (+/- chemotherapy) with curative intent Exclusion Criteria: - Surgery due to head and neck cancer - Previous treatment for head and neck cancer - Tracheostomized patients - Inability to perform exercise intervention - Inability to perform part of 6-minute walking test - Inability to independently fill out questionnaires in Swedish - Previous neurologic or neuromuscular disease

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Preventive physical exercise
Daily physical activity depending on daily condition

Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Cost 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. Up to 5 years post radiotherapy
Other Quality of life for cost-effectiveness analysis The outcomes of intervention compared to usual care using European Quality of life 5 dimensions (EQ5D). Up to 5 years post radiotherapy
Other Quality Adjusted Life Years (QALY) 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. Up to 5 years post radiotherapy
Other Incremental Cost Effectiveness Ratio (ICER) 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. Up to 5 years post radiotherapy
Primary Objectively measured physical activity Measured with an accelerometer. Measures time spent in different activities i minutes/day. Up to 12 months
Primary Subjectively measured physical activity - Saltin-Grimby Measured with the Saltin-Grimby physical activity level scale and the International Physical Activity Questionnaire. Up to 12 months
Primary Subjectively measured physical activity (IPAQ) Measured with the International Physical Activity Questionnaire Up to 12 months
Secondary Health related quality of life (HRQL) using the EORTC QLQ-C30 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. Up to 5 years post radiotherapy
Secondary Health related quality of life (HRQL) using the EORTC QLQ H&N35 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. Up to 5 years post radiotherapy
Secondary 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. Up to 5 years post radiotherapy
Secondary 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. Up to 5 years post radiotherapy
Secondary Maximal Interincisal opening (MIO) Jaw opening measured in millimeters Up to 5 years post radiotherapy
Secondary Body composition Bioelectric impedance analysis. Up to 12 months post radiotherapy
Secondary Grip strength Measured with the a hand dynamometer Up to 12 months post radiotherapy
Secondary 6-minute walking test Measures total walking distance during 6 minutes. Up to 12 months post radiotherapy
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