The Effects of Chiropractic in Adults With Colon Cancer

NCT ID: NCT05310565

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-03-01

Brief 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.

Detailed 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]

Conditions

Colon Cancer Stage III; Colon Cancer Stage IV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Chiropractic

Cervical chiropractic care

Group Type: EXPERIMENTAL

HVLA cervical chiropractic adjustments

Intervention Type: PROCEDURE

Chiropractic high velocity low amplitude adjustment

Interventions

HVLA cervical chiropractic adjustments

Chiropractic high velocity low amplitude adjustment

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Haifa

OTHER

Sponsor Role: collaborator

Life University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Sullivan, DC, PhD

Role: STUDY_DIRECTOR

Life University

Yoram Gidron, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Haifa

Locations

Dr. Sid E. Williams Center for Chiropractic Research

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

I-0019

Identifier Type: -

Identifier Source: org_study_id