Breast CancerPhase 2NCT03916068
Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy
A Phase 2 study testing Hyperbaric Oxygen Therapy, Trental Pill and Vitamin E in people with Breast Cancer, run by Legacy Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hyperbaric Oxygen Therapy, Trental Pill and Vitamin E
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 2 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
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- 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
Who cannot join
- < 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Legacy Emanuel Medical Center
Portland, Oregon, 97227
About this study
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
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
- Breast Cancer
- Being tested
- Hyperbaric Oxygen Therapy, Trental Pill, Vitamin E
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyProcedure or surgery
Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions.
Trental PillDrug
Also called pentoxifylline
Trental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily
Vitamin EDietary supplement
Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | Hyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks) Receives: Procedure: Hyperbaric Oxygen Therapy |
| Trental and Vitamin E | Active comparator | Trental (pentoxifylline), 400 milligrams three times a day in combination with Vitamin E, 400 international units orally twice daily for six months Receives: Drug: Trental Pill; Dietary Supplement: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breast fibrosis using Bakers Grade Assessment
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.
Measured: Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
Secondary outcomes (4)
Objective measurements of tissue pliability using a Tissue Compliance Meter
Measured: 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.
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.
Measured: Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
Pain in radiated breasts using a Visual Analog Scale
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.
Measured: Administered at week 1, week 7, week 13, week 25, week 53, and week 157.
Presence of delayed wound healing, surgical complications, implant revision or loss
Measured: Evaluated at week 1, week 7, week 13, week 25, week 53, and week 157.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jul 2019
- Primary completion2 Oct 2023
- Study completion2 Oct 2023
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Legacy Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enoch Huang, Legacy Health System
- Investigators
- Enoch Huang, MD, Principal investigator, Legacy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916068
- Sponsor's protocol ID
- HBO001
- Status last verified
- Oct 2023
- First submitted
- 4 Apr 2019
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03916068
- Acronym / sponsor ID
- HBO001
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Legacy Health SystemUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | Procedure: Hyperbaric Oxygen TherapyHyperbaric oxygen (HBO2) - 100% oxygen at 2.4 atmospheres ATA for 90 minutes, Monday-Friday for 30 sessions (six weeks) |
| Trental and Vitamin E | Active comparator | Drug: Trental Pill, Dietary Supplement: Vitamin ETrental (pentoxifylline), 400 milligrams three times a day in combination with Vitamin E, 400 international units orally twice daily for six months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- > 18 years of age
- Patient is currently undergoing treatment for breast cancer and is on one of two pathways:
- 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
Key exclusion criteria (13 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyHyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions. | Procedure or surgery | Hyperbaric Oxygen Therapy |
| Trental PillAlso: pentoxifyllineTrental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily | Drug | Trental and Vitamin E |
| Vitamin EVitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily | Dietary supplement | Trental and Vitamin E |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enoch Huang, MD principal investigator
Legacy Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperbaric Oxygen Therapy, Trental Pill and Vitamin E in people with Breast Cancer, run by Legacy Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.