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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Group | Active Comparator | After the 6-week lab assessments, the participants in the delayed group will be offered 6 weeks of chiropractic care. |
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| Immediate Group | Experimental | After the baseline assessment, the participants in the intervention group will receive 12 weeks of chiropractic care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Chiropractic Care | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eligible Randomized Participants | The proportion of eligible participants randomized into the study | 2 years |
| Number of Participants Who Adhere to Study | Proportion of enrolled participants who adhere to the pre-baseline assessment lifestyle restrictions as instructed. This assesses compliance. | 2 years |
| Number of Participants That Can Fulfill Study Activities | Proportion of participants that can fulfill the given baseline assessment as directed. This assesses tolerability | 2 years |
| Number of Participants Who Chiropractic Sessions | Proportion of randomized adults attending ≥90% of chiro sessions within 7 days of the prescribed time frame. This assesses adherence to treatment. | 2 years |
| Number of Enrolled Intervention Group Participants | Proportion of the immediate-start group attending the final assessment session. This assesses retention. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tyson Perez, DC, PhD | Life University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Chiropractic Research | Marietta | Georgia | 30060 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Delayed Chiropractic Care | 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. |
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