The Effects of Chiropractic in Adults With Colon Cancer
Primary Purpose
Colon Cancer Stage III, Colon Cancer Stage IV
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HVLA cervical chiropractic adjustments
Sponsored by
About this trial
This is an interventional other trial for Colon Cancer Stage III focused on measuring Chiropractic, Colon Cancer, Spinal manipulation, Autonomic nervous system, CEA, patient reported outcomes
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with stage 3 or stage 4 colon cancer and currently receiving standard of care with a medical doctor.
- Willingness to shave a small area of hair just under the left clavicle.
Exclusion Criteria:
- Chiropractic or other manual therapy care within the past two weeks
- Active care from another chiropractor or manual therapist during the study.
- Severe orthopedic problems such as non-healed fracture to the back or cervical fusion. Since chiropractic care may be performed, if at any point the attending chiropractor has any concerns about the ability of the participant to tolerate care, the chiropractor will have the authority to remove the participant from the study.
- Individuals with evidence or medical history of clinically significant psychiatric diseases that are uncontrolled and/or untreated will also be excluded. This includes diagnoses such as untreated schizophrenia, schizoaffective disorder, and personality disorders.
- Individuals who currently have a pending health related legal litigation.
- The CareTaker unit requires traditional brachial artery blood pressure recording along with use of the wrist and fingers. Fracture to either wrist, hands, or fingers within the past six weeks that may impact blood pressure readings.
- Individuals with a known heart condition, such as arrhythmia, that results in an aberrant electrocardiogram.
- Individuals with untreated diagnosed osteoporosis or articular instability, such as atlanto-axial instability
- Individuals who do not present with a subluxation in the upper cervical region (C1/C2) during the course of 10 weeks of chiropractic care.
- Since x-rays may be requested for care, participants who are pregnant will be excluded from the study.
- Participants will be excluded if they have metastasis to the spine or pelvis. To rule out metastasis, if a participant is experiencing pain in any region of the spine or pelvis a recent x-ray will be requested. If no recent x-ray (within 30 days) has been performed, then the chiropractor will request the appropriate x-ray based on pain symptomatology.
Sites / Locations
- Dr. Sid E. Williams Center for Chiropractic ResearchRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chiropractic
Arm Description
Cervical chiropractic care
Outcomes
Primary Outcome Measures
Recruitment rate
Length of time needed to recruit target number of participants
Patient adherence rate
Proportion of participants able to adhere to the testing & treatment protocol/schedule
Patient tolerability rate
Proportion of participants able to perform all aspects of the testing regimen
Acceptability of treatment regimen to participants
8-item Theoretical Framework of Acceptability questionnaire
Patient Retention
Proportion of enrolled participants who complete the full trial
Secondary Outcome Measures
Electrodermal activity (EDA) skin conductance level (SCL)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) skin conductance level (SCL)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) skin conductance level (SCL)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) power spectral density (PSD)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) power spectral density (PSD)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) power spectral density (PSD)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
2 sensors on first and second digits of non-dominant hand
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
2 sensors on first and second digits of non-dominant hand
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) pre-ejection period (PEP)
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
2 sensors on chest and 2 sensors on back
ECG interbeat interval
3 sensors on torso
ECG interbeat interval
3 sensors on torso
ECG interbeat interval
3 sensors on torso
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
ECG respiratory sinus arrhythmia (RSA)
3 sensors on torso
ECG de-trended fluctuation analysis
3 sensors on torso
ECG de-trended fluctuation analysis
3 sensors on torso
ECG de-trended fluctuation analysis
3 sensors on torso
Carcinoembryonic antigen (CEA) levels
Off-site blood draw and lab testing
Carcinoembryonic antigen (CEA) levels
Off-site blood draw and lab testing
Patient-reported outcomes
5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Patient-reported outcomes
5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Patient-reported outcomes
5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Patient-reported outcomes
5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Full Information
NCT ID
NCT05310565
First Posted
March 7, 2022
Last Updated
August 1, 2023
Sponsor
Life University
Collaborators
University of Haifa
1. Study Identification
Unique Protocol Identification Number
NCT05310565
Brief Title
The Effects of Chiropractic in Adults With Colon Cancer
Official Title
The Effects of Chiropractic Care on the Quality of Life and Autonomic Nervous System in Adults With Colon Cancer: a Single-arm Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Life University
Collaborators
University of Haifa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
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]
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Stage III, Colon Cancer Stage IV
Keywords
Chiropractic, Colon Cancer, Spinal manipulation, Autonomic nervous system, CEA, patient reported outcomes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-Arm pilot
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chiropractic
Arm Type
Experimental
Arm Description
Cervical chiropractic care
Intervention Type
Procedure
Intervention Name(s)
HVLA cervical chiropractic adjustments
Intervention Description
Chiropractic high velocity low amplitude adjustment
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Length of time needed to recruit target number of participants
Time Frame
Upon reaching target number of completed participant trials
Title
Patient adherence rate
Description
Proportion of participants able to adhere to the testing & treatment protocol/schedule
Time Frame
Upon reaching target number of completed participant trials
Title
Patient tolerability rate
Description
Proportion of participants able to perform all aspects of the testing regimen
Time Frame
Upon reaching target number of completed participant trials
Title
Acceptability of treatment regimen to participants
Description
8-item Theoretical Framework of Acceptability questionnaire
Time Frame
Week 6
Title
Patient Retention
Description
Proportion of enrolled participants who complete the full trial
Time Frame
Upon reaching target number of completed participant trials
Secondary Outcome Measure Information:
Title
Electrodermal activity (EDA) skin conductance level (SCL)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Day 1
Title
Electrodermal activity (EDA) skin conductance level (SCL)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Week 2
Title
Electrodermal activity (EDA) skin conductance level (SCL)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Week 6
Title
Electrodermal activity (EDA) power spectral density (PSD)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Day 1
Title
Electrodermal activity (EDA) power spectral density (PSD)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Week 2
Title
Electrodermal activity (EDA) power spectral density (PSD)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Week 6
Title
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Day 1
Title
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Week 2
Title
Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
Description
2 sensors on first and second digits of non-dominant hand
Time Frame
Week 6
Title
Impedance cardiogram (ICG) pre-ejection period (PEP)
Description
2 sensors on chest and 2 sensors on back
Time Frame
Day 1
Title
Impedance cardiogram (ICG) pre-ejection period (PEP)
Description
2 sensors on chest and 2 sensors on back
Time Frame
Week 2
Title
Impedance cardiogram (ICG) pre-ejection period (PEP)
Description
2 sensors on chest and 2 sensors on back
Time Frame
Week 6
Title
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Description
2 sensors on chest and 2 sensors on back
Time Frame
Day 1
Title
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Description
2 sensors on chest and 2 sensors on back
Time Frame
Week 2
Title
Impedance cardiogram (ICG) initial systolic time interval (ISTI)
Description
2 sensors on chest and 2 sensors on back
Time Frame
Week 6
Title
ECG interbeat interval
Description
3 sensors on torso
Time Frame
Day 1
Title
ECG interbeat interval
Description
3 sensors on torso
Time Frame
Week 2
Title
ECG interbeat interval
Description
3 sensors on torso
Time Frame
Week 6
Title
ECG respiratory sinus arrhythmia (RSA)
Description
3 sensors on torso
Time Frame
Day 1
Title
ECG respiratory sinus arrhythmia (RSA)
Description
3 sensors on torso
Time Frame
Week 2
Title
ECG respiratory sinus arrhythmia (RSA)
Description
3 sensors on torso
Time Frame
Week 6
Title
ECG de-trended fluctuation analysis
Description
3 sensors on torso
Time Frame
Day 1
Title
ECG de-trended fluctuation analysis
Description
3 sensors on torso
Time Frame
Week 2
Title
ECG de-trended fluctuation analysis
Description
3 sensors on torso
Time Frame
Week 6
Title
Carcinoembryonic antigen (CEA) levels
Description
Off-site blood draw and lab testing
Time Frame
Day 1
Title
Carcinoembryonic antigen (CEA) levels
Description
Off-site blood draw and lab testing
Time Frame
Week 6
Title
Patient-reported outcomes
Description
5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Time Frame
Day 0
Title
Patient-reported outcomes
Description
5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Time Frame
Day 1
Title
Patient-reported outcomes
Description
5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Time Frame
Week 2
Title
Patient-reported outcomes
Description
5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Time Frame
Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Austin Garlinghouse
Phone
770-426-2639
Email
research.studies@life.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Sullivan, DC, PhD
Organizational Affiliation
Life University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yoram Gidron, PhD
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Sid E. Williams Center for Chiropractic Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Austin Garlinghouse
Phone
770-426-2639
Email
research.studies@life.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effects of Chiropractic in Adults With Colon Cancer
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