The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study
Abstract Background During the last decade, twelve studies have been published investigating physical exercise interventions (PEIs) in patients with head and neck cancer (HNC) during radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT). These studies showed that these PEIs are safe and feas...
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| Format: | Article |
| Language: | English |
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BMC
2024-04-01
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| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12885-024-12172-2 |
| _version_ | 1797219709329866752 |
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| author | Yvette Kriellaars Jorine Ariane Vermaire Maaike Beugeling Robert Poorter Janneke Drijvers Caroline Margina Speksnijder |
| author_facet | Yvette Kriellaars Jorine Ariane Vermaire Maaike Beugeling Robert Poorter Janneke Drijvers Caroline Margina Speksnijder |
| author_sort | Yvette Kriellaars |
| collection | DOAJ |
| description | Abstract Background During the last decade, twelve studies have been published investigating physical exercise interventions (PEIs) in patients with head and neck cancer (HNC) during radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT). These studies showed that these PEIs are safe and feasible. However, only two of these studies were randomised clinical trials (RCTs) with a satisfying sample size. Thereby, there is no cost-effectiveness study related to a PEI during RT, CRT or BRT ((C/B)RT) for patients with HNC. Therefore, the aim of this study is to investigate and compare physical performance, muscle strength, fatigue, quality of life (QoL), body mass index (BMI), nutritional status, physical activity, treatment tolerability, and health care related costs in patients with HNC with and without a 10 week PEI during (C/B)RT. Methods This study, based on a trial within cohorts (TwiCs) design, will contain a prospective cohort of at least 112 patients. Fifty-six patients will randomly be invited for an experimental 10 week PEI. This PEI consists of both resistance and endurance exercises to optimize physical performance, muscle strength, fatigue, QoL, BMI, nutritional status, physical activity, and treatment tolerability of (C/B)RT. Measurements are at baseline, after 12 weeks, 6 months, and at 12 months. Statistical analyses will be performed for intention-to-treat and instrumental variable analysis. Discussion This study seeks to investigate physical, QoL, and economic implications of a PEI. With a substantial sample size, this study attempts to strengthen and expand knowledge in HNC care upon PEI during (C/B)RT. In conclusion, this study is dedicated to provide additional evidence for PEI in patients with HNC during (C/B)RT. Trial registration protocol was registered at clinicaltrials.gov with number NCT05988060 on 3 August 2023. |
| first_indexed | 2024-04-24T12:37:57Z |
| format | Article |
| id | doaj.art-07dffedb1c2545318374acba7a347241 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-04-24T12:37:57Z |
| publishDate | 2024-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-07dffedb1c2545318374acba7a3472412024-04-07T11:21:29ZengBMCBMC Cancer1471-24072024-04-012411810.1186/s12885-024-12172-2The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital studyYvette Kriellaars0Jorine Ariane Vermaire1Maaike Beugeling2Robert Poorter3Janneke Drijvers4Caroline Margina Speksnijder5Department of Radiation Oncology, Instituut VerbeetenDepartment of Radiation Oncology, Instituut VerbeetenDepartment of Radiation Oncology, Instituut VerbeetenDepartment of Radiation Oncology, Instituut VerbeetenMedifit Fysiotherapie Instituut VerbeetenDepartment of Head and Neck Surgical Oncology, University Medical Center Utrecht, Utrecht UniversityAbstract Background During the last decade, twelve studies have been published investigating physical exercise interventions (PEIs) in patients with head and neck cancer (HNC) during radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT). These studies showed that these PEIs are safe and feasible. However, only two of these studies were randomised clinical trials (RCTs) with a satisfying sample size. Thereby, there is no cost-effectiveness study related to a PEI during RT, CRT or BRT ((C/B)RT) for patients with HNC. Therefore, the aim of this study is to investigate and compare physical performance, muscle strength, fatigue, quality of life (QoL), body mass index (BMI), nutritional status, physical activity, treatment tolerability, and health care related costs in patients with HNC with and without a 10 week PEI during (C/B)RT. Methods This study, based on a trial within cohorts (TwiCs) design, will contain a prospective cohort of at least 112 patients. Fifty-six patients will randomly be invited for an experimental 10 week PEI. This PEI consists of both resistance and endurance exercises to optimize physical performance, muscle strength, fatigue, QoL, BMI, nutritional status, physical activity, and treatment tolerability of (C/B)RT. Measurements are at baseline, after 12 weeks, 6 months, and at 12 months. Statistical analyses will be performed for intention-to-treat and instrumental variable analysis. Discussion This study seeks to investigate physical, QoL, and economic implications of a PEI. With a substantial sample size, this study attempts to strengthen and expand knowledge in HNC care upon PEI during (C/B)RT. In conclusion, this study is dedicated to provide additional evidence for PEI in patients with HNC during (C/B)RT. Trial registration protocol was registered at clinicaltrials.gov with number NCT05988060 on 3 August 2023.https://doi.org/10.1186/s12885-024-12172-2Head and neck cancerPhysical exercise interventionPhysical performanceChemo- or bioradiotherapyTrial within cohortsTwiCs |
| spellingShingle | Yvette Kriellaars Jorine Ariane Vermaire Maaike Beugeling Robert Poorter Janneke Drijvers Caroline Margina Speksnijder The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study BMC Cancer Head and neck cancer Physical exercise intervention Physical performance Chemo- or bioradiotherapy Trial within cohorts TwiCs |
| title | The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study |
| title_full | The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study |
| title_fullStr | The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study |
| title_full_unstemmed | The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study |
| title_short | The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study |
| title_sort | effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer a trial within cohorts study protocol the vital study |
| topic | Head and neck cancer Physical exercise intervention Physical performance Chemo- or bioradiotherapy Trial within cohorts TwiCs |
| url | https://doi.org/10.1186/s12885-024-12172-2 |
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