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

The Effects of Upper Cervical Chiropractic Care in Adult Cancer Survivors With Chronic Cancer-related Fatigue: a Feasibility Trial

The primary aims of the proposed trial are centered around examining the feasibility of conducting a prospective, chiropractic intervention study on a population of cancer survivors living in and around Atlanta, Georgia. This includes evaluating various implementation outcomes including recruitment, adherence, tolerability, retention, acceptability, and data fidelity. The results of this trial will inform the design of a future randomized controlled trial (RCT) that has an increased focus on the efficacy/effectiveness of chiropractic care on chronic cancer-related fatigue (CCRF) and other cancer-related sequelae in cancer survivors.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Fatigue
• Intervention / Treatment: Procedure: Chiropractic care

Detailed Description

Cancer remission is often marked by the cessation of curative-intent treatments (e.g., surgery, chemotherapy, radiotherapy, immunotherapy), however, troublesome signs and symptoms (e.g., fatigue, depression, cognitive impairment, dysautonomia) related to the cancer and its treatments commonly persist for prolonged periods (i.e., months to years). Of these, chronic cancer-related fatigue (CCRF) is one of the most frequently reported and debilitating symptoms. CCRF may be characterized as tiredness or exhaustion persisting for 3 or more months following the completion of the primary curative-intent cancer therapies which is independent on one's quantity or quality of rest and causes impairments in daily functioning and quality of life. Notably, although the mechanisms underlying CCRF are still unclear, there is some evidence that it may be related to autonomic dysregulation.

Irrespective of the cause(s), lack of identification of and treatment for CCRF and other chronic cancer-related sequelae is commonplace. Further, empirical data supporting the efficacy of interventions to remediate these issues are relatively sparse and urgently needed as the global population of cancer survivors continues to increase. Of note, although there is no universally accepted definition of 'cancer survivor', the investigators define it here as someone who has completed their primary curative-intent therapies and is cancer-free (i.e., has no evidence of active disease). This definition is in line with that of the European Organisation of Research & Treatment of Cancer (EORTC) Survivorship Task Force and the EORTC Quality of Life Group.

Interestingly, a recent study suggested that a single chiropractic adjustment may mitigate lower extremity muscular fatigue during isometric exercise in young, healthy males. However, to the investigators' knowledge, the impact of chiropractic care on CCRF and other health-related challenges that burden cancer survivors has yet to be investigated.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Austin Garlinghouse; Phone Number: 770-426-2639; Email: research.studies@life.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Dr. Sid E. Williams Center for Chiropractic Research
      • Contact: Austin Garlinghouse; Phone Number: 770-426-2639; Email: research.studies@life.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Able to understand and provide written informed consent in English
• 18-65 years of age
• Informed by primary health care provider that there is no evidence of active disease (this is sometimes referred to as "complete remission" or "cured")
• Minimum of 3 months since completion of primary curative-intent cancer therapies including surgery, chemotherapy, radiotherapy, and/or immunotherapy (long-term hormonal therapy permitted)
• Onset of fatigue occurred at some point during illness and/or treatment
• FACIT-Fatigue scale score in the moderate-to-severe range (i.e., at or above the 60th percentile)
• If on any prescription medication (including hormonal therapy), on a stable dose for a minimum of 12 weeks with no plans to change medications or doses during the study

Exclusion Criteria:

• Taking any short-acting benzodiazepine including midazolam & triazolam
• Known disorder resulting in syncope/fainting during postural changes (e.g., postural orthostatic tachycardia syndrome, orthostatic hypotension)
• Pacemaker or known heart condition that influences the electrical or mechanical function of the heart (e.g., severe heart valve disease)
• Diagnosed with an externalizing (e.g., substance use, antisocial disorder) or thought (e.g., schizophrenia, paranoid personality, bipolar) disorder that is uncontrolled or untreated
• Diagnosed with rheumatoid arthritis, osteoporosis, or cervical spine instability
• Currently pregnant
• Current litigation related to a physical, health-related injury
• Chronic pain rated at least 3/10 on a visual analog scale (VAS)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chiropractic intervention; Upper cervical chiropractic care	Procedure: Chiropractic care; 6 weeks of chiropractic care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant recruitment	Average number of participants recruited/enrolled per month	6-month data collection period
Participant scheduling	Average time lag between first lab assessment & first chiropractic visit	6-month data collection period
Participant compliance	Proportion of participants violating 1 or more pre-assessment lifestyle restrictions & unable/unwilling to be rescheduled	6-month data collection period
Participant adherence	Proportion of participants not attending at least 80% of their chiropractic sessions	6-month data collection period
Participant tolerability	Proportion of participants unable/unwilling to complete a given assessment	6-month data collection period
Participant retention	Proportion of participants completing the trial	6-month data collection period
Assessment acceptability	Most common patient-related acceptability score for each assessment process/procedure	6-month data collection period
Data fidelity	Proportion of acquisitions from a given assessment that are unsuitable for analysis	6-month data collection period
Implementation acceptability	Most common clinician-rated acceptability score for each trial process/procedure	6-month data collection period

Collaborators and Investigators

• Sponsor: Life University
• Investigators: Principal Investigator: Yori Gidron, PhD, University of Haifa

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: autonomic nervous system; cancer survivors; manipulation; cancer-related fatigue; upper cervical chiropractic
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: I-0029

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