Status:
COMPLETED
Hyperventilation and Oxygenation to Prolong Breath Hold in Breast Cancer Irradiation Treatment
Lead Sponsor:
University Hospital, Ghent
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
With the HOBBIT trial, the investigators want to develop a technology that allows volunteers to hold their breath for a long time. This technique will then be taught to patients with breast cancer to ...
Detailed Description
Radiotherapy (RT) has an established role in breast cancer, complementing surgery and systemic therapies to prevent recurrences and improve survival. Long-Term follow-up shows that the beneficial effe...
Eligibility Criteria
Inclusion
- Female
- Volunteer
- Age ≥ 18 years
- Karnofsky index of at least 90
- Single DIBH of at least twenty seconds without assistance
- Informed consent obtained, signed and dated before specific protocol procedures
Exclusion
- Pregnant women
- Volunteers above WHO Obesity class II (BMI\>35kg/m²)
- Subjects on oxygen treatment during day or night
- COPD or Asthma patients
- Volunteers with pulmonary hypertension
- New York Heart Association functional classification (NYHA) of 2 or less
- Personal history of cerebrovascular disease, aortic disease, coronary artery disease or myocardial disease
- Treatment with antihypertensive medication
- Missing more than three teeth without use of a prosthesis
- Gastric tube present
- Smoking
- Previous breath-holding experience (e.g. diver, etc.)
- Anxiety symptoms grade 1 or higher according to CTCAE v.5
- Mental condition rendering the volunteer unable to understand the nature, scope and possible consequences of the study
Key Trial Info
Start Date :
March 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04091542
Start Date
March 15 2019
End Date
February 22 2021
Last Update
January 4 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital - Radiotherapy Department
Ghent, Belgium, 9000