Exploratory Study on Therapy for Breath Hold in Radiotherapy

NCT03729661 | Completed

• 1 other identifier: ENTheR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lung Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Poroportion of patients able to complete breathhold during training

  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.

  90 seconds

• Reproduciblity of the breath hold

  Overall radiation treatment schedule, varies up to 4 weeks.

• Subjective tolerance as commented by volunteers

  Overall radiation treatment schedule, varies up to 4 weeks.

• Subjective tolerance

  Overall radiation treatment schedule, varies up to 4 weeks.

Study Arms (1)

Breath hold

EXPERIMENTAL

Patients who receive a breathhold CT- and treatment

Behavioral: Nasal High Flow Therapy

Interventions

Nasal High Flow Therapy BEHAVIORAL

Use of Nasal High Flow Therapy during CT and treatment

Breath hold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient refusal
• Hypercapnic COPD patient (= arterial carbon dioxide tension PaCO2 \> 45 mmHg)

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

Maastricht Radiation Oncology

Maastricht, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stéphanie Peeters

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

• Gloria Vilches

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exploratory study

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 5, 2018
• Study Start: April 18, 2019
• Primary Completion: January 3, 2020
• Study Completion: January 3, 2020
• Last Updated: January 18, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)