The Effects of Chiropractic in Adults With Colon Cancer

Colon Cancer Stage III Clinical Trial

— CCX  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05310565
• Other study ID #: I-0019
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: Life University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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]

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer Stage III
• Colon Cancer Stage IV
• Colonic Neoplasms

Intervention

Procedure:
• HVLA cervical chiropractic adjustments
Chiropractic high velocity low amplitude adjustment

Locations

Country	Name	City	State
United States	Dr. Sid E. Williams Center for Chiropractic Research	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Life University	University of Haifa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Length of time needed to recruit target number of participants	Upon reaching target number of completed participant trials
Primary	Patient adherence rate	Proportion of participants able to adhere to the testing & treatment protocol/schedule	Upon reaching target number of completed participant trials
Primary	Patient tolerability rate	Proportion of participants able to perform all aspects of the testing regimen	Upon reaching target number of completed participant trials
Primary	Acceptability of treatment regimen to participants	8-item Theoretical Framework of Acceptability questionnaire	Week 6
Primary	Patient Retention	Proportion of enrolled participants who complete the full trial	Upon reaching target number of completed participant trials
Secondary	Electrodermal activity (EDA) skin conductance level (SCL)	2 sensors on first and second digits of non-dominant hand	Day 1
Secondary	Electrodermal activity (EDA) skin conductance level (SCL)	2 sensors on first and second digits of non-dominant hand	Week 2
Secondary	Electrodermal activity (EDA) skin conductance level (SCL)	2 sensors on first and second digits of non-dominant hand	Week 6
Secondary	Electrodermal activity (EDA) power spectral density (PSD)	2 sensors on first and second digits of non-dominant hand	Day 1
Secondary	Electrodermal activity (EDA) power spectral density (PSD)	2 sensors on first and second digits of non-dominant hand	Week 2
Secondary	Electrodermal activity (EDA) power spectral density (PSD)	2 sensors on first and second digits of non-dominant hand	Week 6
Secondary	Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Day 1
Secondary	Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Week 2
Secondary	Electrodermal activity (EDA) non-specific skin conductance responses (SCR)	2 sensors on first and second digits of non-dominant hand	Week 6
Secondary	Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Day 1
Secondary	Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Week 2
Secondary	Impedance cardiogram (ICG) pre-ejection period (PEP)	2 sensors on chest and 2 sensors on back	Week 6
Secondary	Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Day 1
Secondary	Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Week 2
Secondary	Impedance cardiogram (ICG) initial systolic time interval (ISTI)	2 sensors on chest and 2 sensors on back	Week 6
Secondary	ECG interbeat interval	3 sensors on torso	Day 1
Secondary	ECG interbeat interval	3 sensors on torso	Week 2
Secondary	ECG interbeat interval	3 sensors on torso	Week 6
Secondary	ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Day 1
Secondary	ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Week 2
Secondary	ECG respiratory sinus arrhythmia (RSA)	3 sensors on torso	Week 6
Secondary	ECG de-trended fluctuation analysis	3 sensors on torso	Day 1
Secondary	ECG de-trended fluctuation analysis	3 sensors on torso	Week 2
Secondary	ECG de-trended fluctuation analysis	3 sensors on torso	Week 6
Secondary	Carcinoembryonic antigen (CEA) levels	Off-site blood draw and lab testing	Day 1
Secondary	Carcinoembryonic antigen (CEA) levels	Off-site blood draw and lab testing	Week 6
Secondary	Patient-reported outcomes	5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale	Day 0
Secondary	Patient-reported outcomes	5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale	Day 1
Secondary	Patient-reported outcomes	5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale	Week 2
Secondary	Patient-reported outcomes	5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale	Week 6