Sahlgrenska University Hospital
Gothenburg, 41345, Sweden
Location status: Recruiting
Location contact
Lisa Tuomi
CONTACT
NCT Number: NCT05432297
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Gothenburg, 41345, Sweden
Location status: Recruiting
Lisa Tuomi
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily physical activity depending on daily condition
Time frame: Up to 12 months
Measured with an accelerometer. Measures time spent in different activities i minutes/day.
Time frame: Up to 12 months
Measured with the Saltin-Grimby physical activity level scale and the International Physical Activity Questionnaire.
Time frame: Up to 12 months
Measured with the International Physical Activity Questionnaire
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.
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.
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.
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.
Time frame: Up to 5 years post radiotherapy
Jaw opening measured in millimeters
Time frame: Up to 12 months post radiotherapy
Bioelectric impedance analysis.
Time frame: Up to 12 months post radiotherapy
Measured with the a hand dynamometer
Time frame: Up to 12 months post radiotherapy
Measures total walking distance during 6 minutes.
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.
Time frame: Up to 5 years post radiotherapy
The outcomes of intervention compared to usual care using European Quality of life 5 dimensions (EQ5D).
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.
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.
Contact information is provided by the study sponsor or research team.
Sahlgrenska University Hospital
Other
Preventive Randomized Study Regarding Physical Activity Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer: the Effect of Preventive Intervention for Physical Activity, Function and Quality of Life
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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