The Effects of Chiropractic on Cancer-related Fatigue

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.

• Immediate Chiropractic Care (Other): 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.
• Delayed Chiropractic Care (Other): 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.

Primary outcomes

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

Sex: All, ages: 18 Years to 65 Years

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

• Tyson Perez, DC, PhD, Principal investigator, Life University