The Effects of Chiropractic in Adults With Colon Cancer

Life University

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Conditions

Colon Cancer Stage III Colon Cancer Stage IV

Interventions

HVLA cervical chiropractic adjustmentsPROCEDURE

Chiropractic high velocity low amplitude adjustment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dr. Sid E. Williams Center for Chiropractic Research

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Recruitment rate

Length of time needed to recruit target number of participants

Time frame: Upon reaching target number of completed participant trials

Patient adherence rate

Proportion of participants able to adhere to the testing \& treatment protocol/schedule

Time frame: Upon reaching target number of completed participant trials

Patient tolerability rate

Proportion of participants able to perform all aspects of the testing regimen

Time frame: Upon reaching target number of completed participant trials

Acceptability of treatment regimen to participants

8-item Theoretical Framework of Acceptability questionnaire

Time frame: Week 6

Patient Retention

Proportion of enrolled participants who complete the full trial

Time frame: Upon reaching target number of completed participant trials

Secondary Outcomes

Electrodermal activity (EDA) skin conductance level (SCL)

2 sensors on first and second digits of non-dominant hand

Time frame: Day 1

Electrodermal activity (EDA) skin conductance level (SCL)

2 sensors on first and second digits of non-dominant hand

Time frame: Week 2

Electrodermal activity (EDA) skin conductance level (SCL)

2 sensors on first and second digits of non-dominant hand

Data from ClinicalTrials.gov

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