The Cancer Study: A Pilot Study

NCT ID: NCT07300319

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2028-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer Fatigue

Keywords

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Cancer Fatigue Chiropractic Care Delayed Start

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Delayed Group

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

Group Type ACTIVE_COMPARATOR

Chiropractic Care

Intervention Type OTHER

Participants in the delayed start group will be assigned to chiropractic care for 6 weeks. Participants will have their upper cervical spine (C1/C2) assessed for the presence of vertebral subluxations per the chiropractor's normal and customary procedures and adjusted if necessary.

Immediate Group

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

Group Type EXPERIMENTAL

Chiropractic Care

Intervention Type OTHER

Participants in the immediate start group will be assigned to chiropractic care for 12 weeks. Participants will have their upper cervical spine (C1/C2) assessed for the presence of vertebral subluxations per the chiropractor's normal and customary procedures and adjusted if necessary.

Interventions

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Chiropractic Care

Participants in the immediate start group will be assigned to chiropractic care for 12 weeks. Participants will have their upper cervical spine (C1/C2) assessed for the presence of vertebral subluxations per the chiropractor's normal and customary procedures and adjusted if necessary.

Intervention Type OTHER

Chiropractic Care

Participants in the delayed start group will be assigned to chiropractic care for 6 weeks. Participants will have their upper cervical spine (C1/C2) assessed for the presence of vertebral subluxations per the chiropractor's normal and customary procedures and adjusted if necessary.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Life University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tyson Tyson, Phd

Role: PRINCIPAL_INVESTIGATOR

Life University

Locations

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Center for Chiropractic Research

Atlanta, Georgia, United States

Site Status

Countries

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United States

Central Contacts

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Daekiara Smith-Ireland, MPH, DrPH

Role: CONTACT

Phone: 17704262636

Email: [email protected]

Tyson Principal Investigator, Phd

Role: CONTACT

Email: [email protected]

Facility Contacts

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Daekiara Smith-Ireland, MPH, DrPH

Role: primary

Tyson Principal Investigator, Phd

Role: backup

Other Identifiers

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I-0037

Identifier Type: -

Identifier Source: org_study_id