An interventional study of Optiflow/Ventilator in Breast Cancer, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment
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.
Radiotherapy (RT) has an established role in breast cancer, complementing surgery and systemic therapies to prevent recurrences and improve survival. Long-Term follow-up shows that the beneficial effect on survival is weakened by radiation-induced cardiac and lung cancer mortality, especially in patients with left sided breast cancer or requiring irradiation of regional lymph nodes. Cardiac toxicity is of major concern because many patients receive cardiotoxic systemic treatments like anthracyclines and trastuzumab. Dose and volume of the heart exposed to radiation correlate with severity of cardiac toxicity. The heart dose-volume parameters are highest for patients receiving left-side radiotherapy especially if irradiation of the internal mammary lymph nodes is performed. Risk of (fatal) ischemic heart attack increases linearly with mean heart dose with no known dose threshold. In patients who receive left-side local treatment, heart dose is decreased by using prone positioning or deep-inspiration breath hold (DIBH), or a combination of both.
Previous research has shown that the heart shifts to an anatomical more favorable position in DIBH, away from the breast, chest wall and internal mammary lymph nodes, reducing heart dose. This advantage remains in prone positioning. The goal is to prolong the duration of a single DIBH, to create a long-DIBH (L-DIBH). Possible advantages are better positioning of the patient, execution of technically more difficult procedures and inclusion of regional lymph node (locoregional) irradiation. Most patients can't sustain a DIBH long enough to perform simulation with computed tomography (CT) and delineation during DIBH, so delineation of the laser lines during CT-simulation is performed on the shallow breathing (SB) scan. During positioning of the patient on the radiotherapy machine, a daily cone-beam CT (CBCT) is performed. The duration of this CBCT is 40 seconds, maintaining DIBH during this period is also hard for most patients. So currently the positioning at the moment of treatment is based on the SB CT-scan, whilst the DIBH CT-scan is used for treatment. This could potentially induce suboptimal positioning. Breath hold during CBCT positioning and CT-simulation and delineation could minimize shifts in treatment position. The current DIBH schedules for whole breast cancer radiotherapy without inclusion of the lymph nodes, use between three and six DIBHs of 12 to 18 seconds. Longer DIBH could lead to less DIBHs and faster treatment execution, which is especially important when the lymph nodes are included in the target volumes. Locoregional irradiation, including the lymph nodes, requires between 10 and 14 DIBHs of 15-30 seconds which leads to a total treatment time of around 5 minutes. This represents a substantial physical and mental effort for all but the most able patients.
This research, the first phase of the Hyperventilation Oxygenation Breath hold in Breast cancer Irradiation Treatment (HOBBIT) trail, will focus on finding a technique to assist patients to maintain a long DIBH (L-DIBH) during radiotherapy. Other research has shown a potential increase in duration of breath hold and reduction in rest time between DIBHs using oxygen in combination with hyperventilation. There is a safe way to prolong DIBH to at least 5 minutes. However, the technique requires a long training period for the patient, and 15 minutes of mechanical ventilation before each treatment session, making the technique very time consuming and resource intensive. The investigators hope to simplify the technique by allowing patients to do multiple L-DIBHs during the 5 minutes of treatment time. The investigators found from preliminary tests that using shorter L-DIBHs has several advantages, firstly pre-oxygenation and induction of hypocapnia can be achieved in a shorter time, secondly the duration of training is reduced, and thirdly a the costs are reduced.
Increase in blood pressure is the main risk of L-DIBH. No adverse events of L-DIBH have been reported. In order to minimize the risks during testing, this research project was developed in collaboration with the anesthesiology department, to ensure safety of the participants during L-DIBH. For all subjects, vital parameters will be continuously monitored by medical staff. Safety boundaries are in place which subjects are not allowed to cross during L-DIBH.
The aim of this research is to develop a new and easy technique for L-DIBH in prone and supine position, feasible for daily use at our radiotherapy department. The purpose of the technique is to allow locoregional treatment using a reasonable amount of L-DIBHs, increase patient positioning and accuracy of radiation treatment, and further significantly reduce heart toxicity for left sided cancer patients. The HOBBIT trial includes multiple phases. The first phase is performed on healthy volunteers, different support techniques to prolong DIBH will be tested. In the second phase the most optimal techniques to perform a L-DIBH will be validated on breast cancer patients. Around 40 volunteers will be included in the first phase of the HOBBIT trail, the final amount of volunteers depends on the amount of testing needed to find a technique which fulfills all criteria for phase two. The second phase of the HOBBIT trail will include breast cancer patients treated at our radiotherapy center. The expectations from previous research is that the investigators will see a similar increase in DIBH time, compared to healthy volunteers. The final goal is the use of the technique during locoregional radiation therapy at the University Hospital of Ghent.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 40 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FiO2 changes over the four days in 60 with ventilator, 80 with ventilator, 60 with optiflow and 80 with optiflow.
Device: Optiflow/Ventilator
FiO2 changes over the four days in 80 with ventilator, 60 with ventilator, 80 with optiflow and 60 with optiflow.
Device: Optiflow/Ventilator
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
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
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
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
The position changes over the four days in supine with ventilator, prone with ventilator, supine with optiflow and prone with optiflow.
Device: Optiflow/Ventilator
The position changes over the four days in prone with ventilator, supine with ventilator, prone with optiflow and supine with optiflow.
Device: Optiflow/Ventilator
Participants will have 2 days with optiflow, 2 days with ventilator.
conditions for a technique for L-DIBHs of more than two minutes thirty seconds
duration of preparation/hyperventilation and oxygenation
Time frame: 2 years
Oxygen saturation
fraction of \[oxygen\]-saturated hemoglobin relative to total hemoglobin in the blood
Time frame: 1 year
heart rate
speed of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm)
Time frame: 1 year
diastolic and systolic blood pressure
the pressure of circulating blood on the walls of blood vessels
Time frame: 1 year
EtCO2
patient's end-tidal CO2
Time frame: 1 year
average L-DIBH time
measured in minutes and seconds
Time frame: 1 year
average time needed for SpO2 to recover to normal
measured in minutes and seconds
Time frame: 1 year
average total time needed to perform three L-DIBHs consequently
measured in minutes and seconds
Time frame: 1 year
Measurement of linear anteroposterior displacement
measured in millimetres
Time frame: 1 year
dizziness
an impairment in spatial perception and stability.
Time frame: 1 year
fear
a feeling induced by perceived danger or threat that occurs in certain types of organisms, which causes a change in metabolic and organ functions and ultimately a change in behavior, such as fleeing, hiding, or freezing from perceived traumatic events
Time frame: 1 year
headache
the symptom of pain anywhere in the region of the head or neck
Time frame: 1 year
syncope
syncope
Time frame: 1 year
coughing
a sudden, and often repetitively occurring, protective reflex which helps to clear the large breathing passages from fluids, irritants, foreign particles and microbes
Time frame: 1 year
dyspnea
the feeling that one cannot breathe well enough
Time frame: 1 year
nausea
an unpleasant, diffuse sensation of unease and discomfort, often perceived as an urge to vomit
Time frame: 1 year
vomiting
the involuntary, forceful expulsion of the contents of one's stomach through the mouth and sometimes the nose
Time frame: 1 year
itching
a sensation that causes the desire or reflex to scratch
Time frame: 1 year
pain
a distressing feeling often caused by intense or damaging stimuli
Time frame: 1 year
palpitations
the perceived abnormality of the heartbeat characterized by awareness of cardiac muscle contractions in the chest, which is further characterized by the hard, fast and/or irregular beatings of the heart
Time frame: 1 year
blurred vision
an ocular symptom
Time frame: 1 year
muscle cramps
a sudden, involuntary muscle contraction or over-shortening; while generally temporary and non-damaging, they can cause significant pain, and a paralysis-like immobility of the affected muscle
Time frame: 1 year
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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