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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916068 on ClinicalTrials.gov