Hyperventilation and Oxygenation to Increase Breath Hold in Breast Cancer Irradiation Treatment (HOBBIT) 3: Mental Exercises and Temporal Alteration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Difference in average L-DIBH time between standard and experimental L-DIBH
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Standard L-DIBH
Starts with 2 sessions of normal L-DIBH followed by 2 sessions of L-DIBH combined with mental exercises.
干预措施: Mental Exercises and Temporal Alteration (Behavioral)
Intervention L-DIBH
Starts with 2 sessions of of L-DIBH combined with mental exercises followed by 2 sessions of normal L-DIBH.
干预措施: Mental Exercises and Temporal Alteration (Behavioral)
结局指标
主要结局
Difference in average L-DIBH time between standard and experimental L-DIBH
时间窗: 1 year
Difference in average L-DIBH time between standard and experimental L-DIBH
次要结局
- Average L-DIBH time(1 year)
- Patient reported comfort(1 year)
- Patient preferece for standard or experimental L-DIBH setup(1 year)
- Correctness of the mental exercise(1 year)
- Median L-DIBH time(1 year)
- Minimum and Maximum L-DIBH time(1 year)
- Oxygen Saturation(1 year)
- Heart Rate(1 year)
- Patient report Pain(1 year)