Effects of Cervical Chiropractic Adjustments on Markers of Health in Colon Cancer Patients

  • STATUS
    Recruiting
  • End date
    Feb 24, 2024
  • participants needed
    80
  • sponsor
    Life University
Updated on 20 April 2022

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.

Details
Condition Colon Cancer
Treatment Chiropractic high velocity low amplitude adjustment, Light touch with low amplitude low-velocity intervention to back
Clinical Study IdentifierNCT05310565
SponsorLife University
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

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
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