An interventional study of hyperbaric oxygen chamber in Breast Cancer and Radiation Dermatitis, sponsored by Ilsan Cha hospital. Completed at 1 site in South Korea. Open to female participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Ilsan Cha hospital · Not applicable, Interventional, and Treatment
This study aimed to evaluate reducing the incidence of radiation dermatitis by assigning hyperbaric oxygen therapy to patients with localized breast cancer.
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.
12,828 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 9,498 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Ilsan Cha hospital is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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.
Device: hyperbaric oxygen chamber
The control group will receive systemic education in dermal care and will be under the instruction of usual self-care.
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).
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)
Time frame: At the end of 6 weeks
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)
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
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
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
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
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.
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
Plan to share: No
Ran from Nov 2023 to primary completion in Sep 2024, 10 months.
Of 2,274 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's 10 months is below that.
Counting every sponsor, half of 2,347 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Ilsan Cha hospital