The Effects of Chiropractic in Adults With Colon Cancer
- Conditions
- Colon Cancer Stage IIIColon Cancer Stage IV
- Interventions
- Procedure: HVLA cervical chiropractic adjustments
- Registration Number
- NCT05310565
- Lead Sponsor
- Life University
- 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 \[ECG\]
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chiropractic HVLA cervical chiropractic adjustments Cervical chiropractic care
- Primary Outcome Measures
Name Time Method Recruitment rate Upon reaching target number of completed participant trials Length of time needed to recruit target number of participants
Patient adherence rate Upon reaching target number of completed participant trials Proportion of participants able to adhere to the testing \& treatment protocol/schedule
Patient Retention Upon reaching target number of completed participant trials Proportion of enrolled participants who complete the full trial
Patient tolerability rate Upon reaching target number of completed participant trials Proportion of participants able to perform all aspects of the testing regimen
Acceptability of treatment regimen to participants Week 6 8-item Theoretical Framework of Acceptability questionnaire
- Secondary Outcome Measures
Name Time Method Impedance cardiogram (ICG) initial systolic time interval (ISTI) Week 6 2 sensors on chest and 2 sensors on back
Electrodermal activity (EDA) skin conductance level (SCL) Week 6 2 sensors on first and second digits of non-dominant hand
ECG interbeat interval Week 6 3 sensors on torso
Carcinoembryonic antigen (CEA) levels Week 6 Off-site blood draw and lab testing
Electrodermal activity (EDA) power spectral density (PSD) Week 6 2 sensors on first and second digits of non-dominant hand
ECG respiratory sinus arrhythmia (RSA) Week 6 3 sensors on torso
Patient-reported outcomes Week 6 5 questionnaires: EORTC QLQ-C30, COMPASS-31, PROMIS-29, PROMIS-Cog, Perceived Stress Scale
Electrodermal activity (EDA) non-specific skin conductance responses (SCR) Week 6 2 sensors on first and second digits of non-dominant hand
Impedance cardiogram (ICG) pre-ejection period (PEP) Week 6 2 sensors on chest and 2 sensors on back
ECG de-trended fluctuation analysis Week 6 3 sensors on torso
Trial Locations
- Locations (1)
Dr. Sid E. Williams Center for Chiropractic Research
🇺🇸Atlanta, Georgia, United States