Cancer, Fatigue
Conditions
Keywords
Cancer, Fatigue, Chiropractic Care, Delayed Start
Brief summary
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.
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.
Interventions
OTHERImmediate 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.
OTHERDelayed 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.
Sponsors
Life University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTyson Perez, DC, PhD
Life University
Outcome results
None listed