Effects of Chiropractic on Chronic Cancer-related Fatigue

NCT06235671 | Unknown

• 1 other identifier: I-0029
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Fatigue

Keywords

cancer survivors; upper cervical chiropractic; manipulation; cancer-related fatigue; autonomic nervous system

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Chiropractic intervention

EXPERIMENTAL

Upper cervical chiropractic care

Procedure: Chiropractic care

Interventions

Chiropractic care PROCEDURE

6 weeks of chiropractic care

Chiropractic intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and provide written informed consent in English
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Life University: lead

Study Sites (1)

Dr. Sid E. Williams Center for Chiropractic Research

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yori Gidron, PhD

  University of Haifa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Austin Garlinghouse

CONTACT

770-426-2639; research.studies@life.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm feasibility trial

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)