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ImmunoBoost: The Lymphatic Osteopathic Manipulative Treatment Protocol Study

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Conditions

HealthyOsteopathic Manipulative TreatmentLymphatic Pump TreatmentImmune SystemOMTComplete Blood CountCytokines

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to determine whether osteopathic manipulative treatment (OMT) enhances immune system readiness in healthy adults compared to exercise or sham light treatment. Specifically, the goal of this study is to assess circulating immune cells and signaling molecules in the blood in response to these various treatments. It aims to compare: Complete Blood Counts (CBC) and blood immune signaling molecule levels in healthy adults in response to OMT, sham light touch, and exercise, with measurements taken at multiple time points. Researchers will compare immune blood cells and signaling molecules in response to OMT versus sham light touch and exercise within the same group of healthy adults measured at three time points for each of the three total visits. Participants will do a 15-minute OMT session, a 15-minute light sham session, or a 15-minute exercise session at each of their three separate visits (they will do one of each over the course of their 3 appointments in random order). They will have three blood draws taken at each of those three visits. They will also fill out a Global Physical Activity Questionnaire (GPAQ) survey to assess their level of physical activity throughout the study.

Official Title

Lymphatic Osteopathic Manipulative Treatment Protocol for Healthy Individuals: A Crossover Self-Controlled Clinical Trial

Quick Facts

Study Start:2025-07-14
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06565065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals must be 18 years or older.
  2. * Individuals must provide informed consent.
  3. * Individuals must be healthy with a BMI under 30, with no primary or secondary immune deficiency or autoimmune disease/must not be immunocompromised.
  4. * Individuals must not be using or recently have used any immune-altering medications such as corticosteroids, cyclosporin, tacrolimus, and pimecrolimus
  5. * Individuals must not have had lymphatic OMT or other physical manipulation such as acupuncture, physical therapy, chiropractic, or massage therapy in the previous four weeks before study enrollment.
  6. * Individuals must have the ability to receive OMT with lymphatic techniques.
  7. * Individuals must be able to tolerate 12 minutes of moderate physical activity.
  8. * Individuals must not be pregnant or breastfeeding.
  9. * Individuals must not have had a splenectomy or other spleen or oncologic surgery within the past 6 months.
  10. * Individuals must be infection-free for the past 6 weeks before starting the study and have not received any immunizations within the past 6 weeks.
  11. * Individuals must be willing to avoid strenuous activity at least 24 hours before each visit.
  12. * Individuals must be willing to abstain from moderate to intense activity in the 4 hours between their 2nd blood draw and their final blood draw at each of their three visits.
  1. * Individuals are younger than 18 years of age.
  2. * Individuals who do not provide informed consent.
  3. * Individuals with a BMI over 30, or with primary or secondary immune deficiency or autoimmune disease or is immunocompromised.
  4. * Individuals using or recently have used any immune-altering medications such as corticosteroids, cyclosporin, tacrolimus, and pimecrolimus
  5. * Individuals who have had lymphatic OMT or other physical manipulation such as acupuncture, physical therapy, chiropractic, or massage therapy in the previous four weeks before study enrollment.
  6. * Individuals who don't have the ability to receive OMT with lymphatic techniques.
  7. * Individuals who cannot tolerate 12 minutes of moderate physical activity.
  8. * Individuals who are pregnant or breastfeeding.
  9. * Individuals who have had a splenectomy or other spleen or oncologic surgery within the past 6 months.
  10. * Individuals who have had an infection in the 6 weeks before starting the study and or have received any immunizations within the past 6 weeks.
  11. * Individuals not willing to avoid strenuous activity at least 24 hours before each visit.
  12. * Individuals not willing to abstain from moderate to intense activity in the 4 hours between their 2nd blood draw and their final blood draw at each of their three visits.

Contacts and Locations

Study Contact

Brian Loveless, DO
CONTACT
909-469-8223
bloveless@westernu.edu
Eric S Martinez, BS
CONTACT
909-469-5224
ericmartinez@westernu.edu

Principal Investigator

Brian Loveless, DO
PRINCIPAL_INVESTIGATOR
Professor of NMM/OMM and Chief Medical Officer of WesternU Health

Study Locations (Sites)

Western University of Health Sciences
Pomona, California, 91766
United States
Western University of Health Sciences
Pomona, California, 91766
United States

Collaborators and Investigators

Sponsor: Western University of Health Sciences

  • Brian Loveless, DO, PRINCIPAL_INVESTIGATOR, Professor of NMM/OMM and Chief Medical Officer of WesternU Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-14
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2025-07-14
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • Osteopathic Manipulative Treatment
  • Lymphatic Pump Treatment
  • Immune System
  • OMT
  • Complete Blood Count
  • Cytokines

Additional Relevant MeSH Terms

  • Healthy