The Effects of Chiropractic in Adults With Colon Cancer (CCX)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Colon Cancer Stage III; Colon Cancer Stage IV
• Intervention / Treatment: Procedure: HVLA cervical chiropractic adjustments

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]

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Dr. Sid E. Williams Center for Chiropractic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chiropractic; Cervical chiropractic care	Procedure: HVLA cervical chiropractic adjustments; Chiropractic high velocity low amplitude adjustment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Life University
• Collaborators: University of Haifa
• Investigators: Study Director: Stephanie Sullivan, DC, PhD, Life University; Principal Investigator: Yoram Gidron, PhD, University of Haifa

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Autonomic nervous system; Colon Cancer; Spinal manipulation; patient reported outcomes; Chiropractic; CEA
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: I-0019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No