CClinicalTrials.gg
Sign In
WithdrawnNCT05310565CCXUpdated Apr 3, 2024

The Effects of Chiropractic in Adults With Colon Cancer

An interventional study of HVLA cervical chiropractic adjustments in Colon Cancer Stage III and Colon Cancer Stage IV, sponsored by Life University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by Life University · Not applicable, Interventional, and Other

Why this study was withdrawn
Low recruitment rate
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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]
02

Conditions studied

  • Colon Cancer Stage III
  • Colon Cancer Stage IV

Browse trials for

Keywords

  • Chiropractic
  • Colon Cancer
  • Spinal manipulation
  • Autonomic nervous system
  • CEA
  • patient reported outcomes
03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

Browse Colonic Neoplasms studies →

Lead sponsor

Life University is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Chiropractic

    Cervical chiropractic care

    Procedure: HVLA cervical chiropractic adjustments

Interventions

  • ProcedureHVLA cervical chiropractic adjustments

    Chiropractic high velocity low amplitude adjustment

06

What researchers measure

Primary outcomes

  1. Recruitment rate

    Length of time needed to recruit target number of participants

    Time frame: Upon reaching target number of completed participant trials

  2. Patient adherence rate

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

    Time frame: Upon reaching target number of completed participant trials

  3. Patient tolerability rate

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

    Time frame: Upon reaching target number of completed participant trials

  4. Acceptability of treatment regimen to participants

    8-item Theoretical Framework of Acceptability questionnaire

    Time frame: Week 6

  5. Patient Retention

    Proportion of enrolled participants who complete the full trial

    Time frame: Upon reaching target number of completed participant trials

Secondary outcomes

  1. Electrodermal activity (EDA) skin conductance level (SCL)

    2 sensors on first and second digits of non-dominant hand

    Time frame: Day 1

  2. Electrodermal activity (EDA) skin conductance level (SCL)

    2 sensors on first and second digits of non-dominant hand

    Time frame: Week 2

  3. Electrodermal activity (EDA) skin conductance level (SCL)

    2 sensors on first and second digits of non-dominant hand

    Time frame: Week 6

  4. Electrodermal activity (EDA) power spectral density (PSD)

    2 sensors on first and second digits of non-dominant hand

    Time frame: Day 1

  5. Electrodermal activity (EDA) power spectral density (PSD)

    2 sensors on first and second digits of non-dominant hand

    Time frame: Week 2

  6. Electrodermal activity (EDA) power spectral density (PSD)

    2 sensors on first and second digits of non-dominant hand

    Time frame: Week 6

  7. Electrodermal activity (EDA) non-specific skin conductance responses (SCR)

    2 sensors on first and second digits of non-dominant hand

    Time frame: Day 1

  8. Electrodermal activity (EDA) non-specific skin conductance responses (SCR)

    2 sensors on first and second digits of non-dominant hand

    Time frame: Week 2

  9. Electrodermal activity (EDA) non-specific skin conductance responses (SCR)

    2 sensors on first and second digits of non-dominant hand

    Time frame: Week 6

  10. Impedance cardiogram (ICG) pre-ejection period (PEP)

    2 sensors on chest and 2 sensors on back

    Time frame: Day 1

  11. Impedance cardiogram (ICG) pre-ejection period (PEP)

    2 sensors on chest and 2 sensors on back

    Time frame: Week 2

  12. Impedance cardiogram (ICG) pre-ejection period (PEP)

    2 sensors on chest and 2 sensors on back

    Time frame: Week 6

  13. Impedance cardiogram (ICG) initial systolic time interval (ISTI)

    2 sensors on chest and 2 sensors on back

    Time frame: Day 1

  14. Impedance cardiogram (ICG) initial systolic time interval (ISTI)

    2 sensors on chest and 2 sensors on back

    Time frame: Week 2

  15. Impedance cardiogram (ICG) initial systolic time interval (ISTI)

    2 sensors on chest and 2 sensors on back

    Time frame: Week 6

  16. ECG interbeat interval

    3 sensors on torso

    Time frame: Day 1

  17. ECG interbeat interval

    3 sensors on torso

    Time frame: Week 2

  18. ECG interbeat interval

    3 sensors on torso

    Time frame: Week 6

  19. ECG respiratory sinus arrhythmia (RSA)

    3 sensors on torso

    Time frame: Day 1

  20. ECG respiratory sinus arrhythmia (RSA)

    3 sensors on torso

    Time frame: Week 2

  21. ECG respiratory sinus arrhythmia (RSA)

    3 sensors on torso

    Time frame: Week 6

  22. ECG de-trended fluctuation analysis

    3 sensors on torso

    Time frame: Day 1

  23. ECG de-trended fluctuation analysis

    3 sensors on torso

    Time frame: Week 2

  24. ECG de-trended fluctuation analysis

    3 sensors on torso

    Time frame: Week 6

  25. Carcinoembryonic antigen (CEA) levels

    Off-site blood draw and lab testing

    Time frame: Day 1

  26. Carcinoembryonic antigen (CEA) levels

    Off-site blood draw and lab testing

    Time frame: Week 6

  27. Patient-reported outcomes

    5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale

    Time frame: Day 0

  28. Patient-reported outcomes

    5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale

    Time frame: Day 1

  29. Patient-reported outcomes

    5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale

    Time frame: Week 2

  30. Patient-reported outcomes

    5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale

    Time frame: Week 6

07

Study locations

1 site
  • Dr. Sid E. Williams Center for Chiropractic Research
    Atlanta, Georgia 30308, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05310565
Lead sponsor
Life University
Collaborators
University of Haifa
Responsible party
Sponsor
First posted
Apr 5, 2022
Start date
Jan 1, 2025 (estimated)
Primary completion
Mar 1, 2025 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Apr 3, 2024

Study contacts

Stephanie Sullivan, DC, PhD
study director · Life University
Yoram Gidron, PhD
principal investigator · University of Haifa

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colonic Neoplasms→

Other studies from this sponsor

Life University

Start the discussion