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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06100068
Acronym
HOBBIT-META
Enrollment
36
Registered
2023-10-25
Start date
2023-11-27
Completion date
2025-04-02
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm, Breath Holding, Mental Test, Radiotherapy

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALMental Exercises and Temporal Alteration

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

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Volunteer * Karnofsky index of at least 90 * Able to perform a single DIBH of at least twenty seconds without assistance * Age ≥ 18 years * Informed consent obtained, signed and dated before specific protocol procedures * Female

Exclusion criteria

* 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 * Gastric tube present * Smoking * Previous and substantial breath-holding experience in the past year (e.g., diver, etc.) * Mental condition rendering the volunteer unable to understand the nature, scope and possible consequences of the study

Design outcomes

Primary

MeasureTime frameDescription
Difference in average L-DIBH time between standard and experimental L-DIBH1 yearDifference in average L-DIBH time between standard and experimental L-DIBH

Secondary

MeasureTime frameDescription
Patient reported comfort1 yearComfort on a scale of 0 to 10 where 0 is not comfortable at all and 10 is very comfortable
Patient preferece for standard or experimental L-DIBH setup1 yearWhat setup do patients prefer
Average L-DIBH time1 yearaverage time of a L-DIBH (in standard and experimental setup)
Median L-DIBH time1 yearMedian time of a L-DIBH (in standard and experimental setup)
Minimum and Maximum L-DIBH time1 yearMinimum and Maximum time of a L-DIBH (in standard and experimental setup)
Oxygen Saturation1 yearOxygen Saturation during the L-DIBH
Heart Rate1 yearHeart Rate during the hyperventilation and during the L-DIBH
Patient report Pain1 yearPain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain possible
Correctness of the mental exercise1 yearA grading (perfect-good-fair-poor) regarding the score achieved during the mental exercise

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026