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

April 2, 2024 updated by: Life University

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chiropractic
Cervical chiropractic care
Procedure: HVLA cervical chiropractic adjustments
Chiropractic high velocity low amplitude adjustment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Upon reaching target number of completed participant trials
Length of time needed to recruit target number of participants
Upon reaching target number of completed participant trials
Patient adherence rate
Time Frame: Upon reaching target number of completed participant trials
Proportion of participants able to adhere to the testing & treatment protocol/schedule
Upon reaching target number of completed participant trials
Patient tolerability rate
Time Frame: Upon reaching target number of completed participant trials
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
Time Frame: Week 6
8-item Theoretical Framework of Acceptability questionnaire
Week 6
Patient Retention
Time Frame: Upon reaching target number of completed participant trials
Proportion of enrolled participants who complete the full trial
Upon reaching target number of completed participant trials

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Electrodermal activity (EDA) skin conductance level (SCL)
Time Frame: Day 1
2 sensors on first and second digits of non-dominant hand
Day 1
Electrodermal activity (EDA) skin conductance level (SCL)
Time Frame: Week 2
2 sensors on first and second digits of non-dominant hand
Week 2
Electrodermal activity (EDA) skin conductance level (SCL)
Time Frame: Week 6
2 sensors on first and second digits of non-dominant hand
Week 6
Electrodermal activity (EDA) power spectral density (PSD)
Time Frame: Day 1
2 sensors on first and second digits of non-dominant hand
Day 1
Electrodermal activity (EDA) power spectral density (PSD)
Time Frame: Week 2
2 sensors on first and second digits of non-dominant hand
Week 2
Electrodermal activity (EDA) power spectral density (PSD)
Time Frame: Week 6
2 sensors on first and second digits of non-dominant hand
Week 6
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
Time Frame: Day 1
2 sensors on first and second digits of non-dominant hand
Day 1
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
Time Frame: Week 2
2 sensors on first and second digits of non-dominant hand
Week 2
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
Time Frame: Week 6
2 sensors on first and second digits of non-dominant hand
Week 6
Impedance cardiogram (ICG) pre-ejection period (PEP)
Time Frame: Day 1
2 sensors on chest and 2 sensors on back
Day 1
Impedance cardiogram (ICG) pre-ejection period (PEP)
Time Frame: Week 2
2 sensors on chest and 2 sensors on back
Week 2
Impedance cardiogram (ICG) pre-ejection period (PEP)
Time Frame: Week 6
2 sensors on chest and 2 sensors on back
Week 6
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Time Frame: Day 1
2 sensors on chest and 2 sensors on back
Day 1
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Time Frame: Week 2
2 sensors on chest and 2 sensors on back
Week 2
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Time Frame: Week 6
2 sensors on chest and 2 sensors on back
Week 6
ECG interbeat interval
Time Frame: Day 1
3 sensors on torso
Day 1
ECG interbeat interval
Time Frame: Week 2
3 sensors on torso
Week 2
ECG interbeat interval
Time Frame: Week 6
3 sensors on torso
Week 6
ECG respiratory sinus arrhythmia (RSA)
Time Frame: Day 1
3 sensors on torso
Day 1
ECG respiratory sinus arrhythmia (RSA)
Time Frame: Week 2
3 sensors on torso
Week 2
ECG respiratory sinus arrhythmia (RSA)
Time Frame: Week 6
3 sensors on torso
Week 6
ECG de-trended fluctuation analysis
Time Frame: Day 1
3 sensors on torso
Day 1
ECG de-trended fluctuation analysis
Time Frame: Week 2
3 sensors on torso
Week 2
ECG de-trended fluctuation analysis
Time Frame: Week 6
3 sensors on torso
Week 6
Carcinoembryonic antigen (CEA) levels
Time Frame: Day 1
Off-site blood draw and lab testing
Day 1
Carcinoembryonic antigen (CEA) levels
Time Frame: Week 6
Off-site blood draw and lab testing
Week 6
Patient-reported outcomes
Time Frame: Day 0
5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Day 0
Patient-reported outcomes
Time Frame: Day 1
5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Day 1
Patient-reported outcomes
Time Frame: Week 2
5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Week 2
Patient-reported outcomes
Time Frame: Week 6
5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Life University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Haifa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Stephanie Sullivan, DC, PhD, Life University
  • Principal Investigator: Yoram Gidron, PhD, University of Haifa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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