The Cancer Study: A Pilot Study (CAN)

Life University

Status: Not yet enrolling

Conditions: Cancer; Fatigue

Treatments: Other: Chiropractic Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07300319

I-0037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Delayed Group

Active Comparator group

Description:

After the 6-week lab assessments, the participants in the delayed group will be offered 6 weeks of chiropractic care.

Treatment:

Other: Chiropractic Care

Other: Chiropractic Care

Immediate Group

Experimental group

Description:

After the baseline assessment, the participants in the intervention group will receive 12 weeks of chiropractic care.

Treatment:

Other: Chiropractic Care

Other: Chiropractic Care