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Clinical Trial NCT05432297 for Head and Neck Neoplasms, Physical Inactivity is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Preventive Physical Activity Intervention in Head and Neck Cancer

Recruiting
Clinical Trial NCT05432297 is an interventional study for Head and Neck Neoplasms, Physical Inactivity that is recruiting. It started on January 2, 2023 with plans to enroll 80 participants. Led by Sahlgrenska University Hospital, it is expected to complete by December 1, 2031. The latest data from ClinicalTrials.gov was last updated on November 29, 2024.
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 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
Official Title

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

Conditions
Head and Neck NeoplasmsPhysical Inactivity
Other Study IDs
  • 01
NCT ID Number
NCT05432297
Start Date (Actual)
2023-01-02
Last Update Posted
2024-11-29
Completion Date (Estimated)
2031-12
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPhysical exercise intervention
The physical activity intervention is based on national guidelines of physical activity in cancer rehabilitation. A physiotherapist together with each patient will develop individual adaptations to the exercise protocol, with suggestions on which type of exercise the participant is able to perform depending on their daily condition. Suggestions on physical activity for good, bad and in-between-days will be listed in collaboration with the participant, and the participant will report number of minutes/day in each of the 3 physical activity levels stated.
Preventive Physical Exercise
Daily physical activity depending on daily condition
No InterventionControl
The control group will receive general advice on the importance of physical activity during oncologic treatment, according to local clinical standard.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Objectively measured physical activity
Measured with an accelerometer. Measures time spent in different activities i minutes/day.
Up to 12 months
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
Subjectively measured physical activity (IPAQ)
Measured with the International Physical Activity Questionnaire
Up to 12 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
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
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
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
Maximal Interincisal opening (MIO)
Jaw opening measured in millimeters
Up to 5 years post radiotherapy
Body composition
Bioelectric impedance analysis.
Up to 12 months post radiotherapy
Grip strength
Measured with the a hand dynamometer
Up to 12 months post radiotherapy
6-minute walking test
Measures total walking distance during 6 minutes.
Up to 12 months post radiotherapy
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
  • Receiving radiohterapy (+/- chemotherapy) with curative intent

  • 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
Sahlgrenska University Hospital logoSahlgrenska University Hospital
Study Responsible Party
Lisa Tuomi, Principal Investigator, Principal Investigator, Sahlgrenska University Hospital
Study Central Contact
Contact: Lisa Tuomi, PhD, +46313421000, [email protected]
1 Study Locations in 1 Countries
Sahlgrenska University Hospital, Gothenburg, 41345, Sweden
Lisa Tuomi, Contact
Recruiting