CClinicalTrials.gg
WithdrawnNCT06235671CANUpdated Aug 27, 2026

Effects of Chiropractic on Chronic Cancer-related Fatigue

An interventional study of Chiropractic care in Cancer and Fatigue, sponsored by Life University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Life University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Budget constraints
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer
  • Fatigue

Keywords

  • cancer survivors
  • upper cervical chiropractic
  • manipulation
  • cancer-related fatigue
  • autonomic nervous system
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Chiropractic intervention

    Upper cervical chiropractic care

    Procedure: Chiropractic care

Interventions

  • ProcedureChiropractic care

    6 weeks of chiropractic care

05

What researchers measure

Primary outcomes

  1. Participant recruitment

    Average number of participants recruited/enrolled per month

    Time frame: 6-month data collection period

  2. Participant scheduling

    Average time lag between first lab assessment \& first chiropractic visit

    Time frame: 6-month data collection period

  3. Participant compliance

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

    Time frame: 6-month data collection period

  4. Participant adherence

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

    Time frame: 6-month data collection period

  5. Participant tolerability

    Proportion of participants unable/unwilling to complete a given assessment

    Time frame: 6-month data collection period

  6. Participant retention

    Proportion of participants completing the trial

    Time frame: 6-month data collection period

  7. Assessment acceptability

    Most common patient-related acceptability score on a Likert scale of 1-5 (with 5 being strongly agree) for each assessment process/procedure

    Time frame: 6-month data collection period

  8. Data fidelity

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

    Time frame: 6-month data collection period

  9. Implementation acceptability

    Most common clinician-rated acceptability score on a Likert scale of 1-5 (with 5 being strongly agree) for each trial process/procedure

    Time frame: 6-month data collection period

06

Study locations

1 site
  • Dr. Sid E. Williams Center for Chiropractic Research
    Atlanta, Georgia 30308, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06235671
Lead sponsor
Life University
Responsible party
Sponsor
First posted
Feb 1, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Apr 1, 2025 (estimated)
Completion
May 16, 2025 (estimated)
Last update
Aug 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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