Colon Cancer Clinical Trial

The Effects of Chiropractic in Adults With Colon Cancer

Summary

This preliminary clinical trial will examine the effects of vagal nerve activation via cervical chiropractic adjustments on clinical outcomes in patients with colon cancer. Specifically, hypothesize that participants randomly assigned to receive cervical chiropractic adjustments will have higher heart rate variability (HRV), better health-related quality of life (QOL) and lower levels of both pain and a colon cancer tumor marker, than controls. The aim is to recruit 80 participants with advanced colon cáncer (stage III-IV) who will be measured at baseline for QOL, pain, HRV and a colon cancer marker. Thereafter, they will be randomized to receive a high-velocity low amplitude chiropractic intervention or light touch-based intervention for 10 weeks. Follow up will be at specific intervals across 6 months.

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Full 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]

View Eligibility Criteria

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.

Study is for people with:

Colon Cancer

Study ID:

NCT05310565

Recruitment Status:

Withdrawn

Sponsor:

Life University

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Study ID:

NCT05310565

Recruitment Status:

Withdrawn

Sponsor:


Life University

How clear is this clinincal trial information?

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