Breast CancerHBOTNCT06158347
Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients with Localized Breast Cancer
A study testing hyperbaric oxygen chamber in people with Breast Cancer and Radiation Dermatitis, run by Ilsan Cha hospital at 1 site in South Korea.
Trial summary
This study aimed to evaluate reducing the incidence of radiation dermatitis by assigning hyperbaric oxygen therapy to patients with localized breast cancer. Read more about this study
- Who is it for?
- Ages 19 to 69 years, women only
- Conditions the study is for
- Breast Cancer, Radiation Dermatitis
- What is being tested?
- hyperbaric oxygen chamber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Nov 2023to 25 Sep 2024
- Phase
- Interventional
- 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 19 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 19 and 69
- Patients with biopsy confirmed invasive breast cancer
- Patients who have undergone breast-conserving surgery for the purpose of tumor resection and require adjuvant radiotherapy or have undergone adjuvant radiotherapy within 5 times.
- The Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Those who understand the content of the study, agree to participate in the study, and provide written informed consent
Who cannot join
- Subjects with distant metastases of cancer
- Those whose cancer has invaded the skin of the breast (T4) or who have unhealed wounds on the skin
- Patients who have a history of radiotherapy of the cervical thoracic region for other reasons in the past
- Patients with a history of connective tissue disease
- Subjects with uncontrolled diabetes with HbA1c 7.0 or higher
- Pneumothorax and symptomatic upper respiratory tract infection
Show all 12Show fewer
- If it is judged that there will be a significant decrease in respiratory function
- Undergoing treatments known to interact with hyperbaric oxygen therapy, such as cisplatin, doxorubicin, bleomycin, disulfiram, etc.
- When it is judged that diseases other than cancer (dementia, cerebrovascular disease, severe renal failure, etc.) may have a significant effect on the decline of physical function.
- If it is determined that the life expectancy is not sufficient follow-up within 3 months.
- Pregnant and lactating women
- Other persons who are judged by the researcher to be unsuitable for research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients with Localized Breast Cancer : a Randomized Controlled, Pilot Study
This study aimed to evaluate reducing the incidence of radiation dermatitis by assigning hyperbaric oxygen therapy to patients with localized breast cancer.
Read the detailed description
To evaluate the efficacy of hyperbaric oxygen therapy (HBOT) on the prevention of radiation dermatitis, patients with localized breast cancer between the ages of 19 and 69 were randomly assigned to HBOT group and usual care group in a 1:1 ratio during the period of adjuvant radiotherapy.
The primary purpose of this study was to administer oxygen therapy three times a week during the radiotherapy period for those who were recommended to receive radiotherapy with a Biological equivalent dose (BED10) of 60 Gy or more as adjuvant radiotherapy after breast-conserving surgery to determine the radiation at the end of radiotherapy. The purpose is to compare the incidence of radiation dermatitis of therapy oncology group grade (RTOG grade) grade 2 or higher between the two groups.
The secondary purpose of this study is to evaluate/compare the following items in the relevant treatment group.
- Comparison of the incidence of radiation dermatitis according to RTOG grade
- Catterall skin scoring profile score comparison
- Comparison of Skindex-29 questionnaire scores
- Numeric rating scale score comparison
- Investigation of radiation therapy dose, frequency, schedule, and medical history
- Health-related quality of life questionnaire (EORTC-QLQ-C30)
- Health-related quality of life measurement tool (EQ-5D)
- Safety evaluation
- Health-related quality of life measurement tool (EQ-5D)
- Conditions
- Breast Cancer, Radiation Dermatitis
- Being tested
- hyperbaric oxygen chamber
- Medical subject headings
- Breast Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygen chamberDevice
Hyperbaric oxygen therapy allows patients to breathe 100% oxygen through an O2 Fresh M50 (HBOT Medical, Wonju, South Korea) chamber. Upon entering the chamber, oxygen is supplied by gradually increasing the barometric pressure from normal pressure to 1.5 atmospheres absolute (ATA).
| Study group | Role | What they receive |
|---|---|---|
| HBOT group | Experimental | Hyperbaric oxygen therapy allows the patient to breathe 100% oxygen through an O2 Fresh M50 (HBOT Medical, Wonju, South Korea) chamber. Upon entering the chamber, oxygen is supplied while gradually increasing the atmospheric pressure from normal atmospheric pressure to 1.5 atmospheres absolute (ATA). If the intensity acceptable to the clinical research subject is lower than 1.5 ATA, maintain it at the point acceptable to the research subject and record that value. Receives: Device: hyperbaric oxygen chamber |
| control group | No intervention | The control group will receive systemic education in dermal care and will be under the instruction of usual self-care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of grade 2 or more dermatitis according to RTOG toxicity scale
① Grade 0: No change before or after treatment (No change over baseline)
- Grade 1: Cystic lesions, erythema with faint or reduced skin luster, implantation, dry epidermis shedding, and decreased sweating. (Follicular, faint or dull erythema, epilation, dry desquamation, decreased sweating)
- Grade 2: Tender or bright erythema, ecchymosis, desquamation of the wet epidermis, and moderate edema. (Tender or bright erythema, patchy moist desquamation, moderate edema)
- Grade 3: Confluent skin lesions, desquamation of the wet epidermis other than the area where the skin is folded, pitting edema (Confluent, moist desquamation other than skin folds, pitting edema)
- Grade 4: Ulcerative bleeding, skin necrosis (Ulceration hemorrhage, necrosis)
Measured: At the end of 6 weeks
Secondary outcomes (8)
RTOG toxicity
① Grade 0: No change before or after treatment (No change over baseline)
- Grade 1: Cystic lesions, erythema with faint or reduced skin luster, implantation, dry epidermis shedding, and decreased sweating. (Follicular, faint or dull erythema, epilation, dry desquamation, decreased sweating)
- Grade 2: Tender or bright erythema, ecchymosis, desquamation of the wet epidermis, and moderate edema. (Tender or bright erythema, patchy moist desquamation, moderate edema)
- Grade 3: Confluent skin lesions, desquamation of the wet epidermis other than the area where the skin is folded, pitting edema (Confluent, moist desquamation other than skin folds, pitting edema)
- Grade 4: Ulcerative bleeding, skin necrosis (Ulceration hemorrhage, necrosis)
Measured: At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
CSSP
CSSP is a numerical scale-type evaluation tool developed by Fowler in 1965 to evaluate skin reactions in rats and modified by Catterall for application to patients with radiotherapy-induced dermatitis. [14] Graded from 1 to 10 points depending on the symptoms and severity of dermatitis
Measured: At the end of Day 1, week 5, week 8, week 9, week 10
skindex-29
Skindex-29 is a revision of the existing 61-item Skindex to 29 questions for patients with skin diseases. It maintains the excellent reproducibility, reliability, construct validity, and content validity of the Skindex, while improving the patient's quality of life through symptoms, function, and quality of life. It is a quality of life assessment tool designed to evaluate emotions on three scales. It consists of three scales: function (Fx), emotion (em), symptom (symptom) and a total score (total), linearly ranging from 0 (not affected) to 100 (always affected). A total of 29 items are scored for each scale, and then averaged to calculate the overall quality of life. The lower the score of Skindex-29, the better the quality of life.
Measured: At the end of Day 1, week 5, week 8, week 9, week 10
NRS
NRS is one of the evaluation tools that quantifies the level of discomfort. NRS 0 is defined as no discomfort, and NRS 10 is defined as the maximum discomfort the patient can think of.
Measured: At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
EORTC
This is a questionnaire developed with 30 questions to measure the general quality of life of tumor patients. It evaluates overall quality of life and emotional health by dividing it into five areas: physical, role, cognitive, emotional, and social.
Measured: At the end of Day 1, week 5, week 8, week 9, week 10
EQ-5D
It is the most widely used method of indirect measurement among various indirect measurement methods as it evaluates health status from multiple aspects, and then indirectly calculates the weight of the quality of a specific health status using a preference score assigned in advance for each functional level. The EQ-5D-5L consists of five questions, each of which asks about mobility, self-care, usual activities, pain, and anxiety/depression.
Measured: At the end of Day 1, week 5, week 8, week 9, week 10
Drug Consumption
The type, dose, route of administration, frequency, and purpose of medications administered or taken during the study period (medications prescribed due to current medical history or rescue drugs) will be recorded.
Measured: At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Adverse events
To compare the occurrence of adverse events between the two groups and verify their safety. An adverse event is an undesirable or unintended sign, symptom, or disease that occurs after a procedure in a clinical study and does not necessarily have a causal relationship with the procedure. The investigator will analyze the incidence of adverse events, laboratory abnormalities, and serious adverse events that are suspected to be associated with treatment.
Measured: At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start6 Nov 2023
- Primary completion6 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilsan Cha hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jee Young Lee, CHA University
- Investigators
- Jee Youg Lee, Principal investigator, Ilsan Cha hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158347
- Sponsor's protocol ID
- ICICC-CT-23-01
- Acronym
- HBOT
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JY, Hyun MH, Yang G, Lee S. Efficacy and safety of hyperbaric oxygen therapy for radiation-induced dermatitis in patients with breast cancer: a randomized pilot study. Support Care Cancer. 2025 Apr 21;33(5):399. doi: 10.1007/s00520-025-09463-0.
PubMed 40259026
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients with Localized Breast Cancer : a Randomized Controlled, Pilot Study
- ClinicalTrials.gov ID
- NCT06158347
- Acronym / sponsor ID
- HBOT / ICICC-CT-23-01
- Conditions
- Breast Cancer, Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ilsan Cha hospitalUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 6 Dec 2023 (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 aimed to evaluate reducing the incidence of radiation dermatitis by assigning hyperbaric oxygen therapy to patients with localized breast cancer.
Detailed description
To evaluate the efficacy of hyperbaric oxygen therapy (HBOT) on the prevention of radiation dermatitis, patients with localized breast cancer between the ages of 19 and 69 were randomly assigned to HBOT group and usual care group in a 1:1 ratio during the period of adjuvant radiotherapy.
The primary purpose of this study was to administer oxygen therapy three times a week during the radiotherapy period for those who were recommended to receive radiotherapy with a Biological equivalent dose (BED10) of 60 Gy or more as adjuvant radiotherapy after breast-conserving surgery to determine the radiation at the end of radiotherapy. The purpose is to compare the incidence of radiation dermatitis of therapy oncology group grade (RTOG grade) grade 2 or higher between the two groups.
The secondary purpose of this study is to evaluate/compare the following items in the relevant treatment group.
- Comparison of the incidence of radiation dermatitis according to RTOG grade
- Catterall skin scoring profile score comparison
- Comparison of Skindex-29 questionnaire scores
- Numeric rating scale score comparison
- Investigation of radiation therapy dose, frequency, schedule, and medical history
- Health-related quality of life questionnaire (EORTC-QLQ-C30)
- Health-related quality of life measurement tool (EQ-5D)
- Safety evaluation
- Health-related quality of life measurement tool (EQ-5D)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBOT group | Experimental | Device: hyperbaric oxygen chamberHyperbaric oxygen therapy allows the patient to breathe 100% oxygen through an O2 Fresh M50 (HBOT Medical, Wonju, South Korea) chamber. Upon entering the chamber, oxygen is supplied while gradually increasing the atmospheric pressure from normal atmospheric pressure to 1.5 atmospheres absolute (ATA). If the intensity acceptable to the clinical research subject is lower than 1.5 ATA, maintain it at the point acceptable to the research subject and record that value. |
| control group | No intervention | –The control group will receive systemic education in dermal care and will be under the instruction of usual self-care. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between the ages of 19 and 69
- Patients with biopsy confirmed invasive breast cancer
- Patients who have undergone breast-conserving surgery for the purpose of tumor resection and require adjuvant radiotherapy or have undergone adjuvant radiotherapy within 5 times.
- The Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Those who understand the content of the study, agree to participate in the study, and provide written informed consent
Key exclusion criteria (12 listed)
- Subjects with distant metastases of cancer
- Those whose cancer has invaded the skin of the breast (T4) or who have unhealed wounds on the skin
- Patients who have a history of radiotherapy of the cervical thoracic region for other reasons in the past
- Patients with a history of connective tissue disease
- Subjects with uncontrolled diabetes with HbA1c 7.0 or higher
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 chamberHyperbaric oxygen therapy allows patients to breathe 100% oxygen through an O2 Fresh M50 (HBOT Medical, Wonju, South Korea) chamber. Upon entering the chamber, oxygen is supplied by gradually increasing the barometric pressure from normal pressure to 1.5 atmospheres absolute (ATA). | Device | HBOT group |
Primary outcome
incidence of grade 2 or more dermatitis according to RTOG toxicity scale
Time frame: At the end of 6 weeks
① Grade 0: No change before or after treatment (No change over baseline) * Grade 1: Cystic lesions, erythema with faint or reduced skin luster, implantation, dry epidermis shedding, and decreased sweating. (Follicular, faint or dull erythema, epilation, dry desquamation, decreased sweating) * Grade 2: Tender or bright erythema, ecchymosis, desquamation of the wet epidermis, and moderate edema. (Tender or bright erythema, patchy moist desquamation, moderate edema) * Grade 3: Confluent skin lesions, desquamation of the wet epidermis other than the area where the skin is folded, pitting edema (Confluent, moist desquamation other than skin folds, pitting edema) * Grade 4: Ulcerative bleeding, skin necrosis (Ulceration hemorrhage, necrosis)
8 secondary outcomes
RTOG toxicity
Time frame: At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
CSSP
Time frame: At the end of Day 1, week 5, week 8, week 9, week 10
skindex-29
Time frame: At the end of Day 1, week 5, week 8, week 9, week 10
NRS
Time frame: At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
EORTC
Time frame: At the end of Day 1, week 5, week 8, week 9, week 10
EQ-5D
Time frame: At the end of Day 1, week 5, week 8, week 9, week 10
Drug Consumption
Time frame: At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Adverse events
Time frame: At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Derived from this study: PubMed 40259026Lee JY, Hyun MH, Yang G, Lee S. Efficacy and safety of hyperbaric oxygen therapy for radiation-induced dermatitis in patients with breast cancer: a randomized pilot study. Support Care Cancer. 2025 Apr 21;33(5):399. doi: 10.1007/s00520-025-09463-0.
- 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.
Jee Youg Lee principal investigator
Ilsan Cha hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygen chamber in people with Breast Cancer and Radiation Dermatitis, run by Ilsan Cha hospital at 1 site in South Korea.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 20 Nov 2024. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence of grade 2 or more dermatitis according to RTOG toxicity scale (time frame: At the end of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06158347, which also lists 1 linked publication.
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 20 Nov 2024.