Clinical trial · Interventional
Exploratory Study on Therapy for Breath Hold in Radiotherapy
Exploratory Study on Nasal High Flow Therapy for Breath Hold in Radiotherapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Due to breathing and other motions, tumours, such as breast and lung cancer, as well as their surrounding organs (e.g. the heart), move, which poses a challenge for radiotherapy treatment. Reducing or even stopping breathing, e.g. by irradiating during inspiration, is a way to decrease tumour and organ motion resulting in a reliable target coverage with smaller margins. These smaller margins can result in a better sparing of normal tissues. Furthermore, in some patients, during inspiration, the heart may move away from the target volume making it possible to better spare the heart. Finally, during inspiration, the lung volume is larger and the lung density is lower, which can lead to a lower dose to the surrounding normal lung tissue. Reduction of radiation dose to normal tissues leads to less radiation-induced toxicity. This makes treating breast and lung cancer patients in breath hold (BH) conditions an attractive strategy. Standard BH durations in RT treatment are around 20 seconds, which is not enough to perform a complete CBCT. The health status of lung cancer patients is generally worse compared to breast cancer patients, making it more difficult to treat this patient group during breath hold. Nasal High Flow Therapy (NHFT) is a non-invasive system that provides controlled oxygen concentrations and low levels of positive pressure via a nasal interface. NHFT improves oxygenation in diverse patient groups, and is increasingly used as an alternative to mechanical ventilatory support. It has been shown to be a safe device in several clinical situations and patient populations, such as COPD patients, but also in apneic conditions under general anesthesia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nasal High Flow Therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breath hold
- description
- Patients who receive a breathhold CT- and treatment
- interventionNames
- Behavioral: Nasal High Flow Therapy
Primary outcomes (1)
- measure
- Completing proportion (Tolerability)
- timeFrame
- 40 days
- description
- 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)
Secondary outcomes (5)
- measure
- Poroportion of patients able to complete breathhold during training
- timeFrame
- 90 seconds
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced lung cancer or oligometastatic patients with "local" stage III, treated with curative or radical intent OR * Left-sided breast cancer patients treated with radiotherapy with curative intent. * WHO≤ 2 * ≥ 18 years old * Able to give informed consent Exclusion Criteria: * Patient refusal * Hypercapnic COPD patient (= arterial carbon dioxide tension PaCO2 \> 45 mmHg)
References
Publications (0)
Data not yet available