The Effects of Chiropractic in Adults With Colon Cancer

Study Overview
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Brief Summary
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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
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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]

Official Title
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The Effects of Chiropractic Care on the Quality of Life and Autonomic Nervous System in Adults With Colon Cancer: a Single-arm Pilot Trial

Conditions
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Colon Cancer Stage III, Colon Cancer Stage IV

Intervention / Treatment
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* Procedure: HVLA cervical chiropractic adjustments


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single-Arm pilot
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chiropractic<br>Cervical chiropractic care | Procedure: HVLA cervical chiropractic adjustments<br>* Chiropractic high velocity low amplitude adjustment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Length of time needed to recruit target number of participants | Upon reaching target number of completed participant trials | 
| Patient adherence rate | Proportion of participants able to adhere to the testing & treatment protocol/schedule | Upon reaching target number of completed participant trials | 
| Patient tolerability rate | Proportion of participants able to perform all aspects of the testing regimen | Upon reaching target number of completed participant trials | 
| Acceptability of treatment regimen to participants | 8-item Theoretical Framework of Acceptability questionnaire | Week 6 | 
| Patient Retention | Proportion of enrolled participants who complete the full trial | Upon reaching target number of completed participant trials | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrodermal activity (EDA) skin conductance level (SCL) | 2 sensors on first and second digits of non-dominant hand | Day 1 | 
| Electrodermal activity (EDA) skin conductance level (SCL) | 2 sensors on first and second digits of non-dominant hand | Week 2 | 
| Electrodermal activity (EDA) skin conductance level (SCL) | 2 sensors on first and second digits of non-dominant hand | Week 6 | 
| Electrodermal activity (EDA) power spectral density (PSD) | 2 sensors on first and second digits of non-dominant hand | Day 1 | 
| Electrodermal activity (EDA) power spectral density (PSD) | 2 sensors on first and second digits of non-dominant hand | Week 2 | 
| Electrodermal activity (EDA) power spectral density (PSD) | 2 sensors on first and second digits of non-dominant hand | Week 6 | 
| Electrodermal activity (EDA) non-specific skin conductance responses (SCR) | 2 sensors on first and second digits of non-dominant hand | Day 1 | 
| Electrodermal activity (EDA) non-specific skin conductance responses (SCR) | 2 sensors on first and second digits of non-dominant hand | Week 2 | 
| Electrodermal activity (EDA) non-specific skin conductance responses (SCR) | 2 sensors on first and second digits of non-dominant hand | Week 6 | 
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | Day 1 | 
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | Week 2 | 
| Impedance cardiogram (ICG) pre-ejection period (PEP) | 2 sensors on chest and 2 sensors on back | Week 6 | 
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | Day 1 | 
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | Week 2 | 
| Impedance cardiogram (ICG) initial systolic time interval (ISTI) | 2 sensors on chest and 2 sensors on back | Week 6 | 
| ECG interbeat interval | 3 sensors on torso | Day 1 | 
| ECG interbeat interval | 3 sensors on torso | Week 2 | 
| ECG interbeat interval | 3 sensors on torso | Week 6 | 
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | Day 1 | 
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | Week 2 | 
| ECG respiratory sinus arrhythmia (RSA) | 3 sensors on torso | Week 6 | 
| ECG de-trended fluctuation analysis | 3 sensors on torso | Day 1 | 
| ECG de-trended fluctuation analysis | 3 sensors on torso | Week 2 | 
| ECG de-trended fluctuation analysis | 3 sensors on torso | Week 6 | 
| Carcinoembryonic antigen (CEA) levels | Off-site blood draw and lab testing | Day 1 | 
| Carcinoembryonic antigen (CEA) levels | Off-site blood draw and lab testing | Week 6 | 
| Patient-reported outcomes | 5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale | Day 0 | 
| Patient-reported outcomes | 5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale | Day 1 | 
| Patient-reported outcomes | 5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale | Week 2 | 
| Patient-reported outcomes | 5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale | Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CEA, Chiropractic, Colon Cancer, Spinal manipulation, Autonomic nervous system, patient reported outcomes