Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy
NCT03916068 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2023-10-04
Summary
This study aims to compare patients that receive hyperbaric oxygen or Trental and Vitamin E immediately after completion of radiation therapy to evaluate which treatment best reduces radiation fibrosis.
Conditions
Interventions
- PROCEDURE
-
Hyperbaric Oxygen Therapy
Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions.
- DRUG
-
Trental Pill
Trental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily
- DIETARY_SUPPLEMENT
-
Vitamin E
Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily
Sponsors & Collaborators
-
Legacy Health System
lead OTHER
Principal Investigators
-
Enoch Huang, MD · Legacy Health System
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-01
- Primary Completion
- 2023-10-02
- Completion
- 2023-10-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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