The Effects of Chiropractic on Cancer-related Fatigue (CAN)

The Effects of Chiropractic Care on Adults With Chronic Cancer-related Fatigue: a Pilot Trial

The goal of this randomized controlled study is to investigate the impact of chiropractic care on CCRF (Chronic Cancer Related Fatigue) and other health-related challenges that burden cancer survivors.

Study Overview

• Status: Suspended
• Conditions: Cancer; Fatigue
• Intervention / Treatment: Other: Delayed Chiropractic Care; Other: Immediate Chiropractic Care

Detailed Description

To our knowledge, the impact of chiropractic care on CCRF and other health-related challenges that burden cancer survivors has yet to be investigated. Because this is a pilot trial, the primary outcomes center around feasibility and include 1) randomization, 2) compliance, 3) tolerability, 4) adherence, and 5) retention in each arm. Secondary outcomes include changes in patient-reported outcomes (PROs), electrocardiography (ECG) derived heart rate variability (HRV), impedance cardiography (ICG) derived pre-ejection period (PEP), and number of completed sit-to-stands.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Center for Chiropractic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-65 years of age.
• Self-report that they have been informed by their primary health care provider that they are cancer-free (this is sometimes referred to as 'complete remission' or 'cured').
• Minimum of 3 months since the completion of their primary curative-intent cancer therapies including surgery, chemotherapy, radiotherapy, and/or immunotherapy (long-term hormone therapy permitted)
• Scores in the moderate-to-severe range (i.e., at or above the 60th percentile) on the FACIT-Fatigue scale.
• Fatigue onset was at some point during their illness/treatment & negatively impacts their quality of life & daily functioning.

Exclusion Criteria:

• Chiropractic care within the past 2 weeks
• Taking short-acting benzodiazepines which include midazolam/Versed & triazolam/Halcion.
• Taking GLP-1 medications
• Taking other types of prescription medications (including hormone therapy) and hasn't been on a stable dose for a minimum of 6 weeks with plans to change medications or doses during the study.
• Disorders that cause fainting during rapid postural changes (e.g., POTS, orthostatic hypotension).
• Not able to make a fist or grip objects with one or both hands
• Deaf in one or both ears (hearing aids are ok)
• Heart conditions, including pacemakers, which impact heart function
• Diagnosed with rheumatoid arthritis, osteoporosis, or medically diagnosed cervical spine instability.
• Current litigation related to a physical, health-related injury.
• Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Delayed Group; After the 6-week lab assessments, the participants in the delayed group will be offered 6 weeks of chiropractic care.	Other: Delayed Chiropractic Care; Participants in the delayed start group will be assigned to chiropractic care for 6 weeks. Participants will have their upper cervical spine (C1/C2) assessed for the presence of vertebral subluxations per the chiropractor's normal and customary procedures and adjusted if necessary.
Experimental: Immediate Group; After the baseline assessment, the participants in the intervention group will receive 12 weeks of chiropractic care.	Other: Immediate Chiropractic Care; Participants in the immediate start group will be assigned to chiropractic care for 12 weeks. Participants will have their upper cervical spine (C1/C2) assessed for the presence of vertebral subluxations per the chiropractor's normal and customary procedures and adjusted if necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Eligible Randomized Participants	The proportion of eligible participants randomized into the study	2 years
Number of Participants Who Adhere to Study	Proportion of enrolled participants who adhere to the pre-baseline assessment lifestyle restrictions as instructed. This assesses compliance.	2 years
Number of Participants That Can Fulfill Study Activities	Proportion of participants that can fulfill the given baseline assessment as directed. This assesses tolerability	2 years
Number of Participants Who Chiropractic Sessions	Proportion of randomized adults attending ≥90% of chiro sessions within 7 days of the prescribed time frame. This assesses adherence to treatment.	2 years
Number of Enrolled Intervention Group Participants	Proportion of the immediate-start group attending the final assessment session. This assesses retention.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in PROMIS-Fatigue 13a	Change from baseline of self-reported symptoms of fatigue utilizing the PROMIS-Fatigue 13a scale. The total score ranges from 0 to 52 points after scoring each item properly. This score represents the patient's overall fatigue level. Higher scores point to lower fatigue levels.	2 years
Changes in PROMIS-29	Changes from baseline of self-reported outcomes of a comprehensive overview of a patient's physical, mental, and social health utilizing the PROMIS-29 scale. T score range from 20-8- with a higher score indicating better health.	2 years
Changes in PROMIS-Cog 8	Changes from baseline of self-reported cognitive abilities, such as memory, attention, and decision-making utilizing the PROMIS-Cog 9 scale. T scores range from 20-80. A higher T score range indicates better cognitive functioning.	2 years
Changes in COMPASS-31	Changes from baseline of self-reported outcomes of neurodegenerative system symptoms utilizing the Composite Autonomic Symptom Score-3 scale. Score range from 0-100. A higher score would indicate worse autonomic symptom severity.	2 years
Changes in Perceived Stress Scale (PSS)	Change from baseline of self-reported symptoms of stress utilizing the Perceived Stress Scale 10. Score ranges from 0-40. A lower score indicates less stress, and a higher score indicates high stress.	2 years
Heart Activity (ECG/HRV)	Change from bassline in differences in heart rate variability (HRV)	2 years
Impendence (ICG/PEP)	Changes in baseline of impedance cardiography (ICG) derived pre-ejection period (PEP)	2 years
Sit to Stand Assessment	Changes in number of completed sit to stand during lab assessments.	2 years
Change in Executive Function, Attention, and Inhibitory Control	Change from baseline in performance on the NIH Toolbox Flanker Inhibitory Control and Attention Test, reported as a single age-corrected T-score. Although the task assesses multiple cognitive processes (inhibitory control, attention, accuracy, and reaction time), the NIH Toolbox provides one T-score representing overall executive function performance. Higher scores indicate better inhibitory control and attentional regulation.	2 years
Change in Visual Processing Speed	Change from baseline in performance on the NIH Toolbox Pattern Comparison Processing Speed Test (PCPS). This task measures the cognitive domain of processing speed, including the speed and efficiency with which a participant can visually discriminate and match patterns. Overall T score will represent overall processing speed performance. Higher T-scores indicate faster and more efficient processing.	2 years
Change in Auditory Processing and Speech Recognition in Noise	Change from baseline in performance on the NIH Toolbox Words-In-Noise (WIN) Test. This assessment measures auditory processing, specifically the ability to accurately identify spoken words presented with background noise. NIH Toolbox provides an overall T-score that serves as the composite measure of speech-in-noise processing. Higher T-scores indicate better auditory processing and improved ability to recognize words in noisy environments.	2 years
Change in Fine Motor Skills and Dexterity	Change from baseline in performance on the NIH Toolbox 9-Hole Pegboard Dexterity Test, a standardized measure of fine motor control, manual dexterity, and upper-extremity coordination. Participants are timed while placing and removing pegs from a board as quickly as possible. The primary outcome is the time in seconds required to complete the task, with shorter times indicating better dexterity and motor performance.	2 years
Change in Grip Strength	Change from baseline in performance on the Grip Strength Test, a 3-minute assessment of upper-extremity muscular strength commonly used as an indicator of overall muscle function and physical health. Using a calibrated handgrip dynamometer, participants squeeze with maximal effort on each hand, and the maximum force generated is recorded. Higher force values indicate greater muscular strength.	2 years

Collaborators and Investigators

• Sponsor: Life University
• Investigators: Principal Investigator: Tyson Perez, DC, PhD, Life University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Fatigue; Chiropractic Care; Delayed Start
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Fatigue
• Other Study ID Numbers: I-0037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No