Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT03916068|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : August 31, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Hyperbaric Oxygen Therapy Drug: Trental Pill Dietary Supplement: Vitamin E||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||May 1, 2022|
|Estimated Study Completion Date :||May 1, 2024|
Experimental: Hyperbaric Oxygen Therapy
Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks)
Procedure: Hyperbaric Oxygen Therapy
Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions.
Active Comparator: Trental and Vitamin E
Trental (pentoxifylline), 400 milligrams three times a day in combination with Vitamin E, 400 international units orally twice daily for six months
Drug: Trental Pill
Trental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily
Other Name: pentoxifylline
Dietary Supplement: Vitamin E
Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily
- Change in breast fibrosis using Bakers Grade Assessment [ Time Frame: 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.
- Objective measurements of tissue pliability using a Tissue Compliance Meter [ Time Frame: Obtained at week 1, week 7, week 13, week 25, week 53, and week 157. ]
- Patients' sense of well-being using SF-20 Quality of life survey. [ Time Frame: 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.
- Pain in radiated breasts using a Visual Analog Scale [ Time Frame: 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.
- Presence of delayed wound healing, surgical complications, implant revision or loss [ Time Frame: Evaluated at week 1, week 7, week 13, week 25, week 53, and week 157. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916068
|Contact: Lauren Elliottfirstname.lastname@example.org|
|Principal Investigator:||Enoch Huang, MD||Legacy Health System|