Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Breath Holding | — | UNRESOLVED | — |
| Mental Test | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mental Exercises and Temporal Alteration | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard L-DIBH
- description
- Starts with 2 sessions of normal L-DIBH followed by 2 sessions of L-DIBH combined with mental exercises.
- interventionNames
- Behavioral: Mental Exercises and Temporal Alteration
- type
- EXPERIMENTAL
- label
- Intervention L-DIBH
- description
- Starts with 2 sessions of of L-DIBH combined with mental exercises followed by 2 sessions of normal L-DIBH.
- interventionNames
- Behavioral: Mental Exercises and Temporal Alteration
Primary outcomes (1)
- measure
- Difference in average L-DIBH time between standard and experimental L-DIBH
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDEarly Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19. PMID 22019144
- BACKGROUNDDarby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Bronnum D, Correa C, Cutter D, Gagliardi G, Gigante B, Jensen MB, Nisbet A, Peto R, Rahimi K, Taylor C, Hall P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013 Mar 14;368(11):987-98. doi: 10.1056/NEJMoa1209825. PMID 23484825
- BACKGROUNDVakaet V, Van Hulle H, Schoepen M, Van Caelenberg E, Van Greveling A, Holvoet J, Monten C, De Baerdemaeker L, De Neve W, Coppens M, Veldeman L. Prolonging deep inspiration breath-hold time to 3 min during radiotherapy, a simple solution. Clin Transl Radiat Oncol. 2021 Feb 23;28:10-16. doi: 10.1016/j.ctro.2021.02.007. eCollection 2021 May. PMID 33732910
- BACKGROUNDSchwarz MA, Winkler I, Sedlmeier P. The heart beat does not make us tick: the impacts of heart rate and arousal on time perception. Atten Percept Psychophys. 2013 Jan;75(1):182-93. doi: 10.3758/s13414-012-0387-8. PMID 23143915
- BACKGROUNDVigran HJ, Kapral AG, Tytell ED, Kao MH. Manipulating the perception of time affects voluntary breath-holding duration. Physiol Rep. 2019 Dec;7(23):e14309. doi: 10.14814/phy2.14309. PMID 31833235