Colon Cancer Stage III, Colon Cancer Stage IV
Conditions
Keywords
Chiropractic, Colon Cancer, Spinal manipulation, Autonomic nervous system, CEA, patient reported outcomes
Brief summary
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.
Detailed description
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: 1. Isometric hand grip 2. Postural challenge 3. Patient-reported outcome surveys 4. Off-site blood draw for CEA level testing (only Day 0 and Week 6) Each assessment will consist of the following recordings: 1. Electrodermal activity \[EDA\] 2. Impedance cardiography \[ICG\] 3. Electrocardiogram \[ECG\]
Interventions
PROCEDUREHVLA cervical chiropractic adjustments
Chiropractic high velocity low amplitude adjustment
Sponsors
University of Haifa
Life University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single-Arm pilot
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | Upon reaching target number of completed participant trials | Length of time needed to recruit target number of participants |
| Patient adherence rate | Upon reaching target number of completed participant trials | Proportion of participants able to adhere to the testing & treatment protocol/schedule |
| Patient tolerability rate | 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 | Week 6 | 8-item Theoretical Framework of Acceptability questionnaire |
| Patient Retention | Upon reaching target number of completed participant trials | Proportion of enrolled participants who complete the full trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ECG interbeat interval | Day 1 | 3 sensors on torso |
| ECG respiratory sinus arrhythmia (RSA) | Day 1 | 3 sensors on torso |
| Impedance cardiogram (ICG) pre-ejection period (PEP) | Day 1 | 2 sensors on chest and 2 sensors on back |
| Carcinoembryonic antigen (CEA) levels | Day 1 | Off-site blood draw and lab testing |
| Patient-reported outcomes | Day 0 | 5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale |
| ECG de-trended fluctuation analysis | Day 1 | 3 sensors on torso |
| Electrodermal activity (EDA) skin conductance level (SCL) | Day 1 | 2 sensors on first and second digits of non-dominant hand |
| Electrodermal activity (EDA) power spectral density (PSD) | Day 1 | 2 sensors on first and second digits of non-dominant hand |
| Electrodermal activity (EDA) non-specific skin conductance responses (SCR) | Day 1 | 2 sensors on first and second digits of non-dominant hand |
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | Day 1 | 2 sensors on chest and 2 sensors on back |
Countries
United States
Outcome results
None listed