The Effects of Chiropractic in Adults With Colon Cancer

NCT05310565 | Withdrawn

• 1 other identifier: I-0019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer Stage III; Colon Cancer Stage IV

Keywords

Chiropractic; Colon Cancer; Spinal manipulation; Autonomic nervous system; CEA; patient reported outcomes

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Length of time needed to recruit target number of participants

  Upon reaching target number of completed participant trials

• Patient adherence rate

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

  Upon reaching target number of completed participant trials

• Patient tolerability rate

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

  Upon reaching target number of completed participant trials

• Acceptability of treatment regimen to participants

  8-item Theoretical Framework of Acceptability questionnaire

  Week 6

• Patient Retention

  Proportion of enrolled participants who complete the full trial

  Upon reaching target number of completed participant trials

Secondary Outcomes (30)

• Electrodermal activity (EDA) skin conductance level (SCL)

  Day 1

• Electrodermal activity (EDA) skin conductance level (SCL)

  Week 2

• Electrodermal activity (EDA) skin conductance level (SCL)

  Week 6

• Electrodermal activity (EDA) power spectral density (PSD)

  Day 1

• Electrodermal activity (EDA) power spectral density (PSD)

  Week 2

Study Arms (1)

Chiropractic

EXPERIMENTAL

Cervical chiropractic care

Procedure: HVLA cervical chiropractic adjustments

Interventions

HVLA cervical chiropractic adjustments PROCEDURE

Chiropractic high velocity low amplitude adjustment

Chiropractic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Life University: lead
• University of Haifa: collaborator

Study Sites (1)

Dr. Sid E. Williams Center for Chiropractic Research

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Stephanie Sullivan, DC, PhD

  Life University

  STUDY DIRECTOR

• Yoram Gidron, PhD

  University of Haifa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-Arm pilot

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 5, 2022
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)