Exploratory Study on Therapy for Breath Hold in Radiotherapy

Exploratory Study on Nasal High Flow Therapy for Breath Hold in Radiotherapy.

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lung Cancer
• Intervention / Treatment: Behavioral: Nasal High Flow Therapy

Detailed Description

Due to breathing and other motion, 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 tumor 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. A BH has to be stable and long enough for the duration of a planning CT-scan, cone beam CT (CBCT) scan and treatment delivery. Treatment of left-sided breast cancer with radiotherapy in moderate deep inspiration breath hold (mDIBH) is well established. Also, in MAASTRO clinic, left-sided breast cancer patients are treated in mDIBH, but this is done without any support or control of the breath hold. 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. mDIBH in lung cancer patients is therefore not widely used, and not yet performed in MAASTRO clinic. Ventilation techniques that can support patients in holding their breath might make it a feasible approach in patients with a less favourable performance status, and might increase the duration of a 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. It has however never been used in the context of breath hold support, neither has it been used in radiotherapy practice. The investigators hypothesize that supporting BH with nasal high flow therapy (NHFT) will allow robust radiotherapy treatments of moving targets in a broad patient population allowing for BHs that are long enough, stable and reproducible during a whole treatment course.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6202 AZ
    • Maastricht Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completing proportion (Tolerability)	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)	40 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Poroportion of patients able to complete breathhold during training	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.	90 seconds
Investigation of the stability of a breath hold. Breath hold is considered stable if the variations during a breath hold are within 3 mm.	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.	90 seconds
Reproduciblity of the breath hold	The difference between the baseline chest position (during planning breath hold CT scan) and breath hold during each fraction.	Overall radiation treatment schedule, varies up to 4 weeks.
Subjective tolerance as commented by volunteers	Comments of volunteers after the test will be recorded as free text.	Overall radiation treatment schedule, varies up to 4 weeks.
Subjective tolerance	Comments of volunteers after the test will be recorded	Overall radiation treatment schedule, varies up to 4 weeks.

Collaborators and Investigators

• Sponsor: Maastricht Radiation Oncology
• Investigators: Principal Investigator: Stéphanie Peeters, Maastro Clinic, The Netherlands; Principal Investigator: Gloria Vilches, Maastro Clinic, The Netherlands

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2019
• Primary Completion (ACTUAL): January 3, 2020
• Study Completion (ACTUAL): January 3, 2020

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (ACTUAL): November 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ENThER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No