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Preventive Physical Activity Intervention in Head and Neck Cancer

Recruterend
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De klinische studie NCT05432297 is een interventioneel studie bij Hoofd- en halsneoplasma, Lichamelijke inactiviteit met de status recruterend. Het doel is om 80 deelnemers te includeren vanaf 2 januari 2023. De studie wordt geleid door Sahlgrenska University Hospital en de voltooiing is gepland op 1 december 2031. Laatste update op ClinicalTrials.gov: 29 november 2024.
Beknopte samenvatting
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
Officiële titel

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

Aandoeningen
Hoofd- en halsneoplasmaLichamelijke inactiviteit
Andere studie-ID's
  • 01
NCT-ID
NCT05432297
Startdatum (Werkelijk)
2023-01-02
Laatste update geplaatst
2024-11-29
Verwachte einddatum
2031-12
Inschrijving (Geschat)
80
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Primaire doel
Preventie
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Enkelblind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelPhysical 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
Geen interventieControl
The control group will receive general advice on the importance of physical activity during oncologic treatment, according to local clinical standard.
N.v.t.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • 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
Verantwoordelijke instantie
Lisa Tuomi, Hoofdonderzoeker, Principal Investigator, Sahlgrenska University Hospital
Centraal Contactpersoon
Contact: Lisa Tuomi, PhD, +46313421000, [email protected]
1 Studielocaties in 1 landen
Sahlgrenska University Hospital, Gothenburg, 41345, Sweden
Lisa Tuomi, Contact
Recruterend