Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06235671

Not Yet Recruiting

CAN: Effects of Chiropractic on Chronic Cancer-related Fatigue

Interventional

Phase not listed

Dr. Sid E. Williams Center for Chiropractic Research

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.

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Treatment Category

Procedure

Required Mutations

None

Trial Started

2024-03-01

Last Updated by Sponsor

2024-02-01

Estimated Completion

2024-09-01

Eligibility

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)

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll20

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Upper cervical chiropractic care

Interventions:

Chiropractic care

Outcome Measures

Primary Outcome Measures

Participant recruitment6-month data collection period

Average number of participants recruited/enrolled per month

Participant scheduling6-month data collection period

Average time lag between first lab assessment & first chiropractic visit

Participant compliance6-month data collection period

Proportion of participants violating 1 or more pre-assessment lifestyle restrictions & unable/unwilling to be rescheduled

Participant adherence6-month data collection period

Proportion of participants not attending at least 80% of their chiropractic sessions

Participant tolerability6-month data collection period

Proportion of participants unable/unwilling to complete a given assessment

Participant retention6-month data collection period

Proportion of participants completing the trial

Assessment acceptability6-month data collection period

Most common patient-related acceptability score for each assessment process/procedure

Data fidelity6-month data collection period

Proportion of acquisitions from a given assessment that are unsuitable for analysis

Implementation acceptability6-month data collection period

Most common clinician-rated acceptability score for each trial process/procedure

Secondary Outcome Measures

None

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Trial Sites

This study has 1 trial site

Dr. Sid E. Williams Center for Chiropractic Research
Atlanta, Georgia, US

Not yet recruiting

Atlanta, Georgia, 30308 US

Dr. Sid E. Williams Center for Chiropractic Research

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