Clinical trial NCT05310565: The Effects of Chiropractic in Adults With Colon Cancer
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colon Cancer Stage III
Colon Cancer Stage IV
Keywords: Chiropractic
Colon Cancer
Spinal manipulation
Autonomic nervous system
CEA
patient reported outcomes
Lead sponsor: Life University
Sponsor class: OTHER
Collaborators: name: University of Haifa
First posted: 2022-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-Arm pilot
Primary purpose: OTHER

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 \[ECG\]

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.

Primary outcomes:
measure: Recruitment rate
timeFrame: Upon reaching target number of completed participant trials
measure: Patient adherence rate
timeFrame: Upon reaching target number of completed participant trials
measure: Patient tolerability rate
timeFrame: Upon reaching target number of completed participant trials
measure: Acceptability of treatment regimen to participants
timeFrame: Week 6
measure: Patient Retention
timeFrame: Upon reaching target number of completed participant trials
Secondary outcomes:
measure: Electrodermal activity (EDA) skin conductance level (SCL)
timeFrame: Day 1
measure: Electrodermal activity (EDA) skin conductance level (SCL)
timeFrame: Week 2
measure: Electrodermal activity (EDA) skin conductance level (SCL)
timeFrame: Week 6
measure: Electrodermal activity (EDA) power spectral density (PSD)
timeFrame: Day 1
measure: Electrodermal activity (EDA) power spectral density (PSD)
timeFrame: Week 2
measure: Electrodermal activity (EDA) power spectral density (PSD)
timeFrame: Week 6
measure: Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
timeFrame: Day 1
measure: Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
timeFrame: Week 2
measure: Electrodermal activity (EDA) non-specific skin conductance responses (SCR)
timeFrame: Week 6
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: Day 1
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: Week 2
measure: Impedance cardiogram (ICG) pre-ejection period (PEP)
timeFrame: Week 6
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: Day 1
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: Week 2
measure: Impedance cardiogram (ICG) initial systolic time interval (ISTI)
timeFrame: Week 6
measure: ECG interbeat interval
timeFrame: Day 1
measure: ECG interbeat interval
timeFrame: Week 2
measure: ECG interbeat interval
timeFrame: Week 6
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: Day 1
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: Week 2
measure: ECG respiratory sinus arrhythmia (RSA)
timeFrame: Week 6
measure: ECG de-trended fluctuation analysis
timeFrame: Day 1
measure: ECG de-trended fluctuation analysis
timeFrame: Week 2
measure: ECG de-trended fluctuation analysis
timeFrame: Week 6
measure: Carcinoembryonic antigen (CEA) levels
timeFrame: Day 1
measure: Carcinoembryonic antigen (CEA) levels
timeFrame: Week 6
measure: Patient-reported outcomes
timeFrame: Day 0
measure: Patient-reported outcomes
timeFrame: Day 1
measure: Patient-reported outcomes
timeFrame: Week 2
measure: Patient-reported outcomes
timeFrame: Week 6
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Dr. Sid E. Williams Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life University
name: Stephanie Sullivan, DC, PhD
role: STUDY_DIRECTOR
affiliation: University of Haifa
name: Yoram Gidron, PhD
role: PRINCIPAL_INVESTIGATOR
References: