Exploratory Study on Therapy for Breath Hold in Radiotherapy
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|ClinicalTrials.gov Identifier: NCT03729661|
Recruitment Status : Completed
First Posted : November 5, 2018
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Breast Cancer||Behavioral: Nasal High Flow Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Exploratory study|
|Masking:||None (Open Label)|
|Official Title:||Exploratory Study on Nasal High Flow Therapy for Breath Hold in Radiotherapy.|
|Actual Study Start Date :||April 18, 2019|
|Actual Primary Completion Date :||January 3, 2020|
|Actual Study Completion Date :||January 3, 2020|
Experimental: Breath hold
Patients who receive a breathhold CT- and treatment
Behavioral: Nasal High Flow Therapy
Use of Nasal High Flow Therapy during CT and treatment
- Completing proportion (Tolerability) [ Time Frame: 40 days ]The proportion of patients completing the treatment (CT-scan and alle treatment sessions) in breath hold conditions using nasal high flow therapy (Tolerability of the treatment)
- Poroportion of patients able to complete breathhold during training [ Time Frame: 90 seconds ]Proportion of patients in the population, able to do at least one breath hold of at least 90 seconds during the training session, measured by counting the absolute number of patients.
- Investigation of the stability of a breath hold. Breath hold is considered stable if the variations during a breath hold are within 3 mm. [ Time Frame: 90 seconds ]Investigation of the stability of a breath hold, the position of the chest during the whole duration of the breath hold, monitored by the surface guidance system, installed in the CT and treatment room. Breath hold is considered stable if the variations during a breath hold are within 3 mm.
- Reproduciblity of the breath hold [ Time Frame: Overall radiation treatment schedule, varies up to 4 weeks. ]The difference between the baseline chest position (during planning breath hold CT scan) and breath hold during each fraction.
- Subjective tolerance as commented by volunteers [ Time Frame: Overall radiation treatment schedule, varies up to 4 weeks. ]Comments of volunteers after the test will be recorded as free text.
- Subjective tolerance [ Time Frame: Overall radiation treatment schedule, varies up to 4 weeks. ]Comments of volunteers after the test will be recorded
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729661
|Maastricht Radiation Oncology|
|Maastricht, Netherlands, 6202 AZ|
|Principal Investigator:||Stéphanie Peeters||Maastro Clinic, The Netherlands|
|Principal Investigator:||Gloria Vilches||Maastro Clinic, The Netherlands|