Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06100068
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2023-10-03
Brief Title:
HOBBIT 3 Mental Exercises and Temporal Alteration
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Hyperventilation and Oxygenation to Increase Breath Hold in Breast Cancer Irradiation Treatment HOBBIT 3 Mental Exercises and Temporal Alteration
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOBBIT-META
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 persons 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
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 persons 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 ie 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 persons 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 breathsmin with 40Lmin 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
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 persons 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 breathsmin with 40Lmin 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None