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Lichamelijke activiteit en energieverbruik van hoofdhalskanker patiŽnten.


- candidate number19587
- NTR NumberNTR4828
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-okt-2014
- Secondary IDsMETC 2012/063 METC UMCG
- Public TitleLichamelijke activiteit en energieverbruik van hoofdhalskanker patiŽnten.
- Scientific TitlePhysical activity pattern and energy expenditure of head and neck cancer patients: an explorative study
- ACRONYMPAP studie
- hypothesisThis study primarily aims to explore changes in physical activity pattern and energy expenditure in head and neck cancer patients, during and after treatment with surgery with or without (chemo)radiation. The following primary null hypotheses will be tested in this study: Physical activity of head and neck cancer patients treated with surgery, with or without postoperative (chemo)radiation, does not decrease during treatment period. Total and resting energy expenditure of head and neck cancer patients treated with surgery, with or without postoperative (chemo)radiation, does not change during treatment period. Measured energy expenditure does not differ from estimated energy expenditure in head and neck cancer patients treated with surgery, with or without postoperative (chemo)radiation. The secondary aim of this study is to gain insight in perceived exercise barriers and facilitators, and exercise preferences of head and neck cancer patients.
- Healt Condition(s) or Problem(s) studiedPhysical activity, Physical activity, Head and Neck Squamous Cell Carcinoma, Malnutrition
- Inclusion criteria- Newly diagnosed T1, T2, T3 or T4 malignancy in the oral cavity, larynx, oro- or hypopharynx, to be treated with surgery with or without (chemo)radiation
- Age: at least 18 years
- Able to understand and speak the Dutch language
- Exclusion criteria- Second primary tumor, outside the head and neck region
- Wheel chair dependency
- Comorbidity with a contra-indication for physical exercise
- Severe cognitive disabilities
- Skin allergy or highly sensitive skin
- Palliative treatment
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2012
- planned closingdate19-okt-2015
- Target number of participants23
- InterventionsNot applicable: observational study Measurements: Physical measurements during the study: Body weight Length Muscle mass/fat-free mass: mid upper arm muscle circumference (by means of mid upper arm circumference and triceps skinfold), thigh and calf circumference, bio-electrical impedance analysis Muscle strength: hand grip strength (Jamar hand grip dynamometer), chair to stand test Resting energy expenditure: indirect calorimetry (Cosmed K4b2) Questionnaires: Malnutrition: Patient-Generated Subjective Global Assessment (PG-SGA) Frailty: Frailty Instrument for Primary Care of the Survey of Health, Ageing and Retirement in Europe (SHARE-FI) Fatigue: MVI20 Self efficacy: Exercise Self Efficacy Scale Self regulation: Self regulation Questionnaire Exercise Motivation: Stage of Change Exercise
Performance status: WHO performance status scale
Tumor- and treatment-related symptoms: EORTC QLQ-HN35
- Primary outcomeDaily step count (steps/day)
Measured energy expenditure (in kcal and METs)
- Secondary outcomeTypes of physical activity
Mass/fat-free mass (kg)
Muscle strength (number of stand ups)
Estimated energy expenditure (kcal)
- TimepointsHead and neck cancer patients will be assessed three times: 1) one week before start of treatment, 2) six weeks after end of treatment, and 3) four months after end of treatment.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES M. Sealy
- CONTACT for SCIENTIFIC QUERIES M. Sealy
- Sponsor/Initiator University Medical Center Groningen (UMCG), Hanze University of Applied Sciences Groningen
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG), Hanze University of Applied Sciences
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD1-okt-2014 - 27-feb-2016


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