Trial · NCT03916068
Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy
NCT03916068, Phase 2, Terminated, Legacy Health System
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy. Trials, record NCT03916068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03916068
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy
- NCT number
- NCT03916068
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Legacy Health System
- Conditions
- Breast Cancer
- Interventions
- Hyperbaric Oxygen Therapy, Trental Pill, Vitamin E
- First posted
- 2019-04-16
- Last updated
- 2023-10-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in breast fibrosis using Bakers Grade Assessment | Administered at week 1, week 7, week 13, week 25, week 53, and week 157. | The Bakers Grade Assessment will be used to evaluate if lower incidence and severity of radiation fibrosis is observed in patients receiving post-operative hyperbaric oxygen treatment as compared to Trental and Vitamin E. The difference-from-baseline (DFB) score will be calculated to determine the incidence and severity of radiation fibrosis. Some patients may develop radiation fibrosis at a later time so the assessment will be done multiple throughout the three years to capture timing of fibrosis onset. |
| Secondary | Objective measurements of tissue pliability using a Tissue Compliance Meter | Obtained at week 1, week 7, week 13, week 25, week 53, and week 157. | |
| Secondary | Patients' sense of well-being using SF-20 Quality of life survey. | Administered at week 1, week 7, week 13, week 25, week 53, and week 157. | Short Form 20 is a survey that patients complete to indicate their overall quality of life. The SF-20 is weighted and summed to provide easily interpretable scales for physical and mental health. |
| Secondary | Pain in radiated breasts using a Visual Analog Scale | Administered at week 1, week 7, week 13, week 25, week 53, and week 157. | Visual Analog Scale is a way for patients to assess their pain, on a scale of one to ten with ten being worst pain imaginable. |
| Secondary | Presence of delayed wound healing, surgical complications, implant revision or loss | Evaluated at week 1, week 7, week 13, week 25, week 53, and week 157. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03916068
GET https://conductscience.org/api/trials/v1/NCT03916068/registered