Effects of Cervical Chiropractic Adjustments on Markers of Health in Colon Cancer Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Chiropractic Adjustment Chiropractic high velocity low amplitude adjustment |
Procedure: Chiropractic high velocity low amplitude adjustment
Chiropractic high velocity low amplitude adjustment
|
| Active Comparator: Light touched-based intervention Light touch with low amplitude low-velocity intervention to back |
Procedure: Light touch with low amplitude low-velocity intervention to back
Light touch with low amplitude low-velocity intervention to back
|
Outcome Measures
Primary Outcome Measures
- Heart Rate Variability [Baseline (pre)]
Heart rate Variability will be assessed using resting electrocardiography.
- Heart Rate Variability [One month follow up]
Heart rate Variability will be assessed using resting electrocardiography.
- Health Related Quality of Life [Baseline (pre)]
Patient reported outcome assessment using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life for Cancer Patients (QLQ-C30) and visual analog pain scale.
- Health Related Quality of Life [One month]
Patient reported outcome assessment using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life for Cancer Patients (QLQ-C30) visual analog pain scale.
- Health Related Quality of Life [Three months]
Patient reported outcome assessment using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life for Cancer Patients (QLQ-C30) visual analog pain scale.
- Health Related Quality of Life [Six months]
Patient reported outcome assessment using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life for Cancer Patients (QLQ-C30) visual analog pain scale.
- Blood marker for colon cancer - CarcinoembryonicAntigen (CEA) [Baseline (pre)]
CarcinoembryonicAntigen (CEA) blood marker for colon cancer
- Blood marker for colon cancer - CarcinoembryonicAntigen (CEA) [Three months]
CarcinoembryonicAntigen (CEA) blood marker for colon cancer
- Blood marker for colon cancer - CarcinoembryonicAntigen (CEA) [Six months]
CarcinoembryonicAntigen (CEA) blood marker for colon cancer
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with stage 3 or stage 4 colon cancer and currently receiving standard of care with a medical doctor.
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Willingness to shave a small area of hair just under the left clavicle.
Exclusion Criteria:
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Chiropractic or other manual therapy care within the past two weeks
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Active care from another chiropractor or manual therapist during the study.
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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.
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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.
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Individuals who currently have a pending health related legal litigation.
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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.
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Individuals with a known heart condition, such as arrhythmia, that results in an aberrant electrocardiogram.
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Individuals with untreated diagnosed osteoporosis or articular instability, such as atlanto-axial instability
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Individuals who do not present with a subluxation in the upper cervical region (C1/C2) during the course of 10 weeks of chiropractic care.
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Since x-rays may be requested for care, participants who are pregnant will be excluded from the study.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr. Sid E. Williams Center for Chiropractic Research | Atlanta | Georgia | United States | 30308 |
Sponsors and Collaborators
- Life University
- University of Haifa
Investigators
- Study Director: Stephanie Sullivan, Life Univeristy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I-0019