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Radiation Injuries

Free breathing during conformal radiation

Breath holding during conformal radiation

Free breathing

Breath holding

Line CLAUDE, MD

The purpose of this study is to evaluate the interest of breath holding for the prevention of radiation pneumonitis following conformal radiation therapy.

Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath holding during conformal radiation.

The primary objective of the study is to establish the efficacy of breath holding, compared to free breathing, in the prevention of early pulmonary toxicity following conformal radiation.

Several departments of radiotherapy, many pneumology units and two basic and applied research laboratories take part in this multicentric study.

The number of patients required to demonstrate a reduction in radiation pneumonitis from 45 % to 22.5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion period should be approximately 3 years.

The secondary objectives are:

* Validation of the Lent-Soma toxicity scale by comparison to the RTOG scale,
* Response rate at different times: week 6-8, 1 year and 2 years after the end of irradiation,
* Progression-free survival rate at 1 year and 2 years after the end of irradiation
* Confirmation of the predictive value of serum cytokine levels (IL-6 and IL-10) during irradiation for the occurrence of early radiation toxicity, and analysis of the correlation between these serum levels at inclusion and the expression polymorphism of candidate genes.

Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer

Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy

Ministry of Health, France

Centre Leon Berard

Skin and Connective Tissue Diseases

Breast Neoplasms

Hyperventilation

Breast Diseases

Skin Diseases

Starts with 2 sessions of normal L-DIBH followed by 2 sessions of L-DIBH combined with mental exercises.

Starts with 2 sessions of of L-DIBH combined with mental exercises followed by 2 sessions of normal L-DIBH.

Mental exercises during L-DIBH to distort the awareness of passage of time

Mental Exercises and Temporal Alteration

Liv Veldeman, MD, PhD

Vincent Huybrechts, MD

In the HOBBIT-trial by Vakaet et al. A protocol was developed to increase breath-hold time using (voluntary) hyperventilation and oxygenation to achieve DIBH times around 3 minutes.

Multiple non-medical interventions are being investigated to prolong a L-DIBH that are feasible in clinical practice. One of these methods will be to alter the time perception of the subjects. It has been noted in multiple studies (both medical and not) that slowing a person's perception of time results in an increase in breath-hold time. This alteration in time perception can be achieved with the use of a slowed clock as well as the usage of mental or physical exercises to preoccupy the subjects.

Volunteers will then be randomised into either the standard arm or the intervention arm. The intervention arm will follow standard protocol regarding DIBH preparation, though during the L-DIBH they will be asked to perform a simple mental exercise on a tablet. After 2 sessions of 3 L-DIBHs each, there will be a cross-over to the other arm in order to ascertain comfort and preference with each technique.

Adjuvant radiation therapy has a well-established role in the treatment of breast cancer complementing surgery and systemic treatment, improving survival and local control in both local and regional disease. The long-term follow-up, however, does show increased cardiac morbidity and mortality. The risk of heart disease is greatest in patients receiving a higher heart dosage i.e., left sided breast cancer and irradiation of the internal mammary lymph nodes and does not appear to have a threshold. Lowering heart dose can be achieved by improved planning methods as well as increasing the distance between the target volume and the heart. A deep inspiration breath-hold (DIBH) is often used to this end.

An unassisted DIBH is between 12 and 30 seconds; a simple breast irradiation averages 4 DIBHS for completion. More advanced radiotherapy plans (including lymph nodes) needs up to 20 DIBHs. This great amount is both physically and mentally exhausting.

A protocol was developed to increase breath-hold time using (voluntary) hyperventilation and oxygenation to achieve DIBH times around 3 minutes.

Multiple non-medical interventions are being investigated to prolong a L-DIBH that are feasible in clinical practice. One of these methods will be to alter the time perception of the subjects. It has been noted in multiple studies (both medical and not) that slowing a person's perception of time results in an increase in breath-hold time. This alteration in time perception can be achieved with the use of a slowed clock as well as the usage of mental or physical exercises to preoccupy the subjects.

Other important factors on the duration of breath holds are stress and anxiety, which may also be influenced by (relaxation) exercises (including Abdominal breathing).

The standard protocol for the first phase will be based on the results of the original HOBBIT trial.

40 Volunteers will be asked to perform 3 L-DIBHs each preceded by 3 minutes of hyperventilation at 16 breaths/min with 40L/min at FiO2 60%.

Volunteers will then be randomised into either the standard arm or the intervention arm. The intervention arm will follow standard protocol regarding DIBH preparation, though during the L-DIBH they will be asked to perform a simple mental exercise on a tablet.

Data regarding L-DIBH time, side-effects and volunteer reported stress and comfort will be reported.

Volunteers in each group will be asked to perform 2 series of 3 L-DIBHs on 2 separate days. After having finished these 2 series, there will be a cross-over to the other arm. This cross-over will evaluate the known effect of the learning bias that we see with breath-hold and show whether this effect has an impact on the anticipated benefit of the intervention. With the cross-over we can also ascertain volunteer comfort and preference with each the technique.

HOBBIT 3: Mental Exercises and Temporal Alteration

Hyperventilation and Oxygenation to Increase Breath Hold in Breast Cancer Irradiation Treatment (HOBBIT) 3: Mental Exercises and Temporal Alteration

Various side-effects (regarding, nausea, dizziness, coughing, palpitations, cramps)

Difference in average L-DIBH time between standard and experimental L-DIBH

Comfort on a scale of 0 to 10 where 0 is not comfortable at all and 10 is very comfortable

average time of a L-DIBH (in standard and experimental setup)

Median time of a L-DIBH (in standard and experimental setup)

Minimum and Maximum time of a L-DIBH (in standard and experimental setup)

Heart Rate during the hyperventilation and during the L-DIBH

Pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain possible

A grading (perfect-good-fair-poor) regarding the score achieved during the mental exercise

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer	NCT00349102	Carcinoma, Non-...	Free breathing Breath holding	18 Years -	Centre Leon Berard
HOBBIT 3: Mental Exercises and Temporal Alteration	NCT06100068	Breast Neoplasm Radiotherapy Breath Holding Mental Test	Mental Exercise...	18 Years -	University Hospital, Ghent

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