Status:
COMPLETED
HOBBIT 3: Mental Exercises and Temporal Alteration
Lead Sponsor:
University Hospital, Ghent
Conditions:
Breast Neoplasm
Radiotherapy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
In the HOBBIT-trial by Vakaet et al. A protocol was developed to increase breath-hold time using (voluntary) hyperventilation and oxygenation to achieve DIBH times around 3 minutes. Multiple non-medi...
Detailed Description
Adjuvant radiation therapy has a well-established role in the treatment of breast cancer complementing surgery and systemic treatment, improving survival and local control in both local and regional d...
Eligibility Criteria
Inclusion
- Volunteer
- Karnofsky index of at least 90
- Able to perform a single DIBH of at least twenty seconds without assistance
- Age ≥ 18 years
- Informed consent obtained, signed and dated before specific protocol procedures
- Female
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
- Gastric tube present
- Smoking
- Previous and substantial breath-holding experience in the past year (e.g., diver, etc.)
- Mental condition rendering the volunteer unable to understand the nature, scope and possible consequences of the study
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06100068
Start Date
November 27 2023
End Date
July 1 2024
Last Update
August 27 2024
Active Locations (1)
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1
University Hospital - Radiotherapy Department
Ghent, Belgium, 9000