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Colon Cancer Stage IIICCXNCT05310565

The Effects of Chiropractic in Adults With Colon Cancer

A study testing HVLA cervical chiropractic adjustments in people with Colon Cancer Stage III and Colon Cancer Stage IV, run by Life University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer Stage III, Colon Cancer Stage IV
What is being tested?
HVLA cervical chiropractic adjustments
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jan 2025to 1 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dr. Sid E. Williams Center for Chiropractic Research

    Atlanta, Georgia, 30308

Other trials in United States

About this study

Official title: The Effects of Chiropractic Care on the Quality of Life and Autonomic Nervous System in Adults With Colon Cancer: a Single-arm Pilot Trial

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]
Being tested
HVLA cervical chiropractic adjustments
Keywords
Chiropractic, Colon Cancer, Spinal manipulation, Autonomic nervous system, CEA, patient reported outcomes
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HVLA cervical chiropractic adjustmentsProcedure or surgery

    Chiropractic high velocity low amplitude adjustment

Study groups in NCT05310565
Study groupRoleWhat they receive
ChiropracticExperimentalCervical chiropractic care
Receives: Procedure: HVLA cervical chiropractic adjustments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Length of time needed to recruit target number of participants

    Measured: Upon reaching target number of completed participant trials

  2. Patient adherence rate

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

    Measured: Upon reaching target number of completed participant trials

  3. Patient tolerability rate

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

    Measured: Upon reaching target number of completed participant trials

  4. Acceptability of treatment regimen to participants

    8-item Theoretical Framework of Acceptability questionnaire

    Measured: Week 6

  5. Patient Retention

    Proportion of enrolled participants who complete the full trial

    Measured: Upon reaching target number of completed participant trials

Secondary outcomes (30)

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

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

    Measured: Day 1

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

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

    Measured: Week 2

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

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

    Measured: Week 6

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

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

    Measured: Day 1

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

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

    Measured: Week 2

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

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

    Measured: Week 6

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

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

    Measured: Day 1

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

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

    Measured: Week 2

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

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

    Measured: Week 6

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

    2 sensors on chest and 2 sensors on back

    Measured: Day 1

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

    2 sensors on chest and 2 sensors on back

    Measured: Week 2

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

    2 sensors on chest and 2 sensors on back

    Measured: Week 6

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

    2 sensors on chest and 2 sensors on back

    Measured: Day 1

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

    2 sensors on chest and 2 sensors on back

    Measured: Week 2

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

    2 sensors on chest and 2 sensors on back

    Measured: Week 6

  16. ECG interbeat interval

    3 sensors on torso

    Measured: Day 1

  17. ECG interbeat interval

    3 sensors on torso

    Measured: Week 2

  18. ECG interbeat interval

    3 sensors on torso

    Measured: Week 6

  19. ECG respiratory sinus arrhythmia (RSA)

    3 sensors on torso

    Measured: Day 1

  20. ECG respiratory sinus arrhythmia (RSA)

    3 sensors on torso

    Measured: Week 2

  21. ECG respiratory sinus arrhythmia (RSA)

    3 sensors on torso

    Measured: Week 6

  22. ECG de-trended fluctuation analysis

    3 sensors on torso

    Measured: Day 1

  23. ECG de-trended fluctuation analysis

    3 sensors on torso

    Measured: Week 2

  24. ECG de-trended fluctuation analysis

    3 sensors on torso

    Measured: Week 6

  25. Carcinoembryonic antigen (CEA) levels

    Off-site blood draw and lab testing

    Measured: Day 1

  26. Carcinoembryonic antigen (CEA) levels

    Off-site blood draw and lab testing

    Measured: Week 6

  27. Patient-reported outcomes

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

    Measured: Day 0

  28. Patient-reported outcomes

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

    Measured: Day 1

  29. Patient-reported outcomes

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

    Measured: Week 2

  30. Patient-reported outcomes

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

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Why it stopped: Low recruitment rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single-Arm pilot
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05310565
Sponsor's protocol ID
I-0019
Acronym
CCX
Status last verified
Apr 2024
First submitted
7 Mar 2022
Last updated
3 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing HVLA cervical chiropractic adjustments in people with Colon Cancer Stage III and Colon Cancer Stage IV, run by Life University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: Upon reaching target number of completed participant trials). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05310565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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