Clinical trial · Interventional
Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy
A Pilot Study Comparing Acute Post-Radiation Hyperbaric Oxygen (HBO2) Versus Trental and Vitamin E for Breast Cancer Patients Who Have Recently Completed Radiation Therapy as Part of Their Treatment Course
NCT03916068CI-TRIAL-00070205terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient enrollment
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperbaric Oxygen Therapy | Procedure | — | UNRESOLVED |
| Trental Pill | Drug | — | UNRESOLVED |
| Vitamin E | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hyperbaric Oxygen Therapy
- description
- Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks)
- interventionNames
- Procedure: Hyperbaric Oxygen Therapy
- type
- ACTIVE_COMPARATOR
- label
- Trental and Vitamin E
- description
- Trental (pentoxifylline), 400 milligrams three times a day in combination with Vitamin E, 400 international units orally twice daily for six months
- interventionNames
- Drug: Trental Pill
- Dietary Supplement: Vitamin E
Primary outcomes (1)
- measure
- Change in breast fibrosis using Bakers Grade Assessment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \> 18 years of age * Patient is currently undergoing treatment for breast cancer and is on one of two pathways: * Pathway 1 involves lumpectomy with radiation therapy, recurrence years later, mastectomy and tissue expander with further radiation therapy * Pathway 2 involves mastectomy and tissue expander, 6 weeks of radiation therapy, and an implant in 6 months * Undergone mastectomy with expander or implant reconstruction \> 2 weeks before starting radiation therapy * Completed chest wall irradiation in the past 3 days * Willing to stop herbal medications as directed by provider * Willing to stop daily use of supplemental vitamin E (Multivitamin with vitamin E component is acceptable, vitamin E cream is also acceptable) * Willing to have photographs of chest area taken for research purposes only * Therapeutic PT-INR for participants taking Coumadin * If tissue expanders remain intact during radiation, plan for conversion to the final implants must occur \> 4 months after completing radiation * Willing to travel to a Legacy Health facility for study related visits * Agree to attend study visits outside of standard of care visits, if needed * Willing to engage in pre/post testing and survey/phone calls * Willing to attend all 6 weeks of HBOT if randomized to that group Exclusion Criteria: * \< 18 years of age * Pregnant or lactating * Have final implant placed \< 2 weeks before start of radiation therapy * Plan to place final impacts \< 4 months from the completion of radiation therapy, if tissue expanders are intact during radiation therapy * Have evidence of ongoing infection or implant exposure before start of radiation therapy * Radiation completed more than 3 days prior to study start * Unable to comply with protocol * Unable to provide written informed consent * Unwilling or unable to stop oral supplemental Vitamin E * PT-INR outside of acceptable range for participants taking Coumadin * Any delay in radiation treatment greater than 14 days * Investigator does not believe study participation is in the best interest of the patient * History of a seizure within the last 5 years
References
Publications (0)
Data not yet available
No reference posted for this study.