The Effects of Chiropractic Care on the Quality of Life and Autonomic Nervous System in Adults With Colon Cancer: a Single-arm Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Patient adherence rate
研究概览
简要总结
The main objectives of this single-arm pilot trial are to investigate the feasibility of our protocol in terms of 1) recruitment, 2) adherence, 3) tolerability, 4) acceptability and 5) retention. We aim to recruit 20 participants with advanced colon cancer (stage 3-4) who will have assessments of their autonomic nervous system function, carcinoembryonic antigen (CEA) levels, and patient-reported outcomes. Thereafter, patients will be directed to a nearby field clinic to receive twice-weekly cervical assessments & high-velocity, low-amplitude (HVLA) cervical adjustments for a period of 6 weeks. Re-assessments will be performed following 2 weeks and 6 weeks of chiropractic care.
详细描述
After providing informed consent, individuals will undergo 6 weeks of chiropractic care. Throughout these 6 weeks there will be three assessments (Day 1, Week 2, and Week 6) that each include the following:
- Isometric hand grip
- Postural challenge
- Patient-reported outcome surveys
- Off-site blood draw for CEA level testing (only Day 0 and Week 6)
Each assessment will consist of the following recordings:
- Electrodermal activity [EDA]
- Impedance cardiography [ICG]
- Electrocardiogram [ECG]
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males & females 18 years of age or older
- •Able to provide informed consent
- •Diagnosed with stage 3 or stage 4 colon cancer and currently receiving standard of care with a medical doctor.
排除标准
- •Individuals with a known disorder resulting in syncope/fainting during postural changes (e.g., POTS, orthostatic hypotension)
- •Cancer has metastasized to the cervical spine
- •Individuals who have had a serious injury or surgery to the head, torso, lower body within the past 6 months.
- •Individuals with evidence or medical history of clinically significant psychiatric disorder like anti-social disorder, schizophrenia, or borderline personality disorder that is uncontrolled or untreated.
- •Individuals who currently have pending health related legal litigation.
- •Individuals with a known heart condition (e.g., arrhythmia) that could result in an aberrant electrocardiogram.
- •Individuals with a pacemaker
- •Individuals who are on short benzodiazepines which include midazolam & triazolam
- •Individuals with conditions that could result in neck instability such as rheumatoid arthritis.
- •Individuals who do not present with a subluxation in the upper cervical region (C1/C2) at any point during the 6 weeks of chiropractic care.
- •Individuals with a condition that may cause weak or brittle bones such as osteoporosis
- •Since x-rays may be requested for care, participants who are pregnant will be excluded from the study.
结局指标
主要结局
Patient adherence rate
时间窗: Upon reaching target number of completed participant trials
Proportion of participants able to adhere to the testing \& treatment protocol/schedule
Patient Retention
时间窗: Upon reaching target number of completed participant trials
Proportion of enrolled participants who complete the full trial
Recruitment rate
时间窗: Upon reaching target number of completed participant trials
Length of time needed to recruit target number of participants
Patient tolerability rate
时间窗: Upon reaching target number of completed participant trials
Proportion of participants able to perform all aspects of the testing regimen
Acceptability of treatment regimen to participants
时间窗: Week 6
8-item Theoretical Framework of Acceptability questionnaire
次要结局
- Impedance cardiogram (ICG) initial systolic time interval (ISTI)(Week 6)
- Electrodermal activity (EDA) skin conductance level (SCL)(Week 6)
- ECG interbeat interval(Week 6)
- Carcinoembryonic antigen (CEA) levels(Week 6)
- Electrodermal activity (EDA) power spectral density (PSD)(Week 6)
- ECG respiratory sinus arrhythmia (RSA)(Week 6)
- Patient-reported outcomes(Week 6)
- Electrodermal activity (EDA) non-specific skin conductance responses (SCR)(Week 6)
- Impedance cardiogram (ICG) pre-ejection period (PEP)(Week 6)
- ECG de-trended fluctuation analysis(Week 6)