HOBBIT 3: Mental Exercises and Temporal Alteration

NCT06100068 | Completed DMC

• 1 other identifier: EC/2023/0256 (PA-2023-0017)
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm; Radiotherapy; Breath Holding; Mental Test

Outcome Measures

Primary Outcomes (1)

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

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

  1 year

Secondary Outcomes (9)

• Patient reported comfort

  1 year

• Patient preferece for standard or experimental L-DIBH setup

  1 year

• Average L-DIBH time

  1 year

• Median L-DIBH time

  1 year

• Minimum and Maximum L-DIBH time

  1 year

Other Outcomes (1)

• Breath-Hold related side-effects

  1 year

Study Arms (2)

Standard L-DIBH

ACTIVE COMPARATOR

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

Behavioral: Mental Exercises and Temporal Alteration

Intervention L-DIBH

EXPERIMENTAL

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

Behavioral: Mental Exercises and Temporal Alteration

Interventions

Mental Exercises and Temporal Alteration BEHAVIORAL

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

Intervention L-DIBH; Standard L-DIBH

Eligibility Criteria

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

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital - Radiotherapy Department

Ghent, 9000, Belgium

Location

Related Publications (5)

• Early 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 BACKGROUND

• Darby 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 BACKGROUND

• Vakaet 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 BACKGROUND

• Schwarz 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 BACKGROUND

• Vigran 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 25, 2023
• Study Start: November 27, 2023
• Primary Completion: December 31, 2024
• Study Completion: April 2, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)