Hyperventilation and Oxygenation to Prolong Breath Hold in Breast Cancer Irradiation Treatment

NCT04091542 | Completed

• 1 other identifier: EC2019/0127
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 be able to hold their breath long-term during the irradiation. After all, research has shown that the heart is in a better position when the patient enters her breath after a deep inhalation, as a result of which there is less unwanted radiation of the heart. To develop this technique the investigators use healthy volunteers, who are asked several times to hold their breath as long as comfortable. Before the respiratory arrest the investigators allow these volunteers to hyperventilate, administer oxygen and cause hyperinflation of the lungs. The volunteers come back four times, on four consecutive days. The first day they receive a short training. Afterwards oxygen is administered for a few minutes while the volunteers are asked to hyperventilate. Afterwards, by using the learned technique, they must hold their breath for as long as possible, comfortably. They should hold their breath 3 times in total with a short break in between. The following days there is always a change in the preparation protocol, compared to the previous study. Different parameters in the protocol will be changed for different groups of volunteers, this is based on randomization. In this way the effect of different parameters in the preparation of the AHS can be investigated. The investigators will use this information to develop a new protocol for extending the duration of breathing to two minutes and thirty seconds for use during radiotherapy treatment. The method for finding the optimal technique is iterative optimization. This method follows a process of development, testing, feedback and redevelopment cycles. Iteratively, these cycles of development use the prior research to further elaborate the most promising discoveries and drop paths that do not produce the desired result. During the development The investigators listen to the input of different people: doctors, nurses, support staff, engineers and the participants, to guarantee the usability of the technique on the radiotherapy device. Once the researchers think they have found a solution that meets all the conditions, a group of untrained volunteers are asked to implement the technique. With this the investigators validate the technique for later use in breast cancer patients.

Conditions

Breast Cancer

Keywords

breath hold; hyperventilation; oxygenation

Outcome Measures

Primary Outcomes (1)

• conditions for a technique for L-DIBHs of more than two minutes thirty seconds

  duration of preparation/hyperventilation and oxygenation

  2 years

Secondary Outcomes (21)

• Oxygen saturation

  1 year

• heart rate

  1 year

• diastolic and systolic blood pressure

  1 year

• EtCO2

  1 year

• average L-DIBH time

  1 year

Study Arms (8)

FiO2 group 1

EXPERIMENTAL

FiO2 changes over the four days in 60 with ventilator, 80 with ventilator, 60 with optiflow and 80 with optiflow.

Device: Optiflow/Ventilator

FiO2 group 2

EXPERIMENTAL

FiO2 changes over the four days in 80 with ventilator, 60 with ventilator, 80 with optiflow and 60 with optiflow.

Device: Optiflow/Ventilator

Duration 1

EXPERIMENTAL

In duration goup changes the preparation over the four days in 2 min. with ventilator, 6 min. with ventilator, 2 min. with optiflow and 8 min. with optiflow.

Device: Optiflow/Ventilator

Duration 2

EXPERIMENTAL

In duration goup changes the preparation over the four days in 6 min. with ventilator, 2 min. with ventilator, 6 min. with optiflow and 2 min. with optiflow.

Device: Optiflow/Ventilator

respiratory rate 1

EXPERIMENTAL

In the RR group changes the respiratory rate in the four days: 16 times with ventilator, 20 times with ventilator, 16 times with optiflow and 20 times with optiflow.

Device: Optiflow/Ventilator

respiratory rate 2

EXPERIMENTAL

In the RR group changes the respiratory rate in the four days: 20 times with ventilator, 16 times with ventilator, 20 times with optiflow and 16 times with optiflow.

Device: Optiflow/Ventilator

Position 1

EXPERIMENTAL

The position changes over the four days in supine with ventilator, prone with ventilator, supine with optiflow and prone with optiflow.

Device: Optiflow/Ventilator

Position 2

EXPERIMENTAL

The position changes over the four days in prone with ventilator, supine with ventilator, prone with optiflow and supine with optiflow.

Device: Optiflow/Ventilator

Interventions

Optiflow/Ventilator DEVICE

Participants will have 2 days with optiflow, 2 days with ventilator.

Duration 1; Duration 2; FiO2 group 1; FiO2 group 2; Position 1; Position 2; respiratory rate 1; respiratory rate 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital - Radiotherapy Department

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms; Hyperventilation

Interventions

Ventilators, Mechanical

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Liv Veldeman, dr

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: September 16, 2019
• Study Start: March 15, 2019
• Primary Completion: December 31, 2019
• Study Completion: February 22, 2021
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

BE (1)