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Hyperbaric Oxygen Therapy for Breast Cancer

Phase 2
Waitlist Available
Led By Enoch Huang, MD
Research Sponsored by Legacy Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up obtained at week 1, week 7, week 13, week 25, week 53, and week 157.
Awards & highlights

Study Summary

This trial will compare two groups of patients: those who receive hyperbaric oxygen therapy and those who receive Trental and Vitamin E. The trial will evaluate which treatment is more effective in reducing radiation fibrosis.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~obtained at week 1, week 7, week 13, week 25, week 53, and week 157.
This trial's timeline: 3 weeks for screening, Varies for treatment, and obtained at week 1, week 7, week 13, week 25, week 53, and week 157. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in breast fibrosis using Bakers Grade Assessment
Secondary outcome measures
Objective measurements of tissue pliability using a Tissue Compliance Meter
Breast
Patients' sense of well-being using SF-20 Quality of life survey.
+1 more

Side effects data

From 2018 Phase 2 trial • 20 Patients • NCT02363959
10%
Repeat bronchoscopy due to bleeding during biopsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hyperbaric Oxygen, Airway Biopsy
No Hyperbaric Oxygen, Airway Biopsy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hyperbaric Oxygen TherapyExperimental Treatment1 Intervention
Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks)
Group II: Trental and Vitamin EActive Control2 Interventions
Trental (pentoxifylline), 400 milligrams three times a day in combination with Vitamin E, 400 international units orally twice daily for six months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperbaric Oxygen Therapy
2016
Completed Phase 4
~720

Find a Location

Who is running the clinical trial?

Legacy Health SystemLead Sponsor
35 Previous Clinical Trials
3,680 Total Patients Enrolled
2 Trials studying Breast Cancer
60 Patients Enrolled for Breast Cancer
Enoch Huang, MD5.02 ReviewsPrincipal Investigator - Legacy Health System
Legacy Health System
2 Previous Clinical Trials
51 Total Patients Enrolled
5Patient Review
Dr. Huang is excellent. He is always honest in his communication with me about my health, and he is very attentive and compassionate about my medical needs.

Media Library

Hyperbaric Oxygen Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03916068 — Phase 2
Breast Cancer Research Study Groups: Hyperbaric Oxygen Therapy, Trental and Vitamin E
Breast Cancer Clinical Trial 2023: Hyperbaric Oxygen Therapy Highlights & Side Effects. Trial Name: NCT03916068 — Phase 2
Hyperbaric Oxygen Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03916068 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants being monitored for this research effort?

"Enrollment for this medical study has concluded. Initially posted on July 1st 2019, the trial was last modified on August 15th 2022. Breast cancer is currently the subject of 2599 active clinical trials whilst 20 other studies are recruiting patients to test Hyperbaric Oxygen Therapy."

Answered by AI

What medical issues does Hyperbaric Oxygen Therapy usually treat?

"Hyperbaric Oxygen Therapy has become a customary treatment for vitamin deficiency, but can also aid with parenteral nutrition, long-chain omega-3 fatty acid supplementation and alcoholic liver diseases."

Answered by AI

Are there still opportunities to join this experiment?

"Unfortunately, this clinical trial is no longer recruiting patients. Initially posted on the 1st of July 2019 and last updated on the 15th of August 2022, it has now been closed to further recruitment. If you're still seeking out studies for breast cancer related issues or Hyperbaric Oxygen Therapy there are 2599 trials and 20 respective studies presently looking for participants."

Answered by AI

Does the FDA endorse Hyperbaric Oxygen Therapy as a viable treatment option?

"This alternative treatment, Hyperbaric Oxygen Therapy, scored a 2 on our team's scale due to its Phase 2 trial status. This indicates that while there is some data indicating safety, efficacy has yet to be established."

Answered by AI

Are there any analogous studies that have explored the efficacy of Hyperbaric Oxygen Therapy?

"Presently, twenty clinical trials are assessing the effects of Hyperbaric Oxygen Therapy. Of those studies, five have entered Phase 3 and can be found in 52 different medical centres around North America, with most located in Memphis, Tennessee."

Answered by AI
~0 spots leftby Apr 2025