Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients With Localized Breast Cancer

Breast Cancer Clinical Trial

— HBOT  

Official title:

Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients With Localized Breast Cancer : a Randomized Controlled, Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158347
• Other study ID #: ICICC-CT-23-01
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Ilsan Cha hospital
• Contact: Jee Youg Lee
• Phone: 082-31-782-3113
• Email: happiade[@]chamc.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to evaluate reducing the incidence of radiation dermatitis by assigning hyperbaric oxygen therapy to patients with localized breast cancer.

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. 1. Comparison of the incidence of radiation dermatitis according to RTOG grade 2. Catterall skin scoring profile score comparison 3. Comparison of Skindex-29 questionnaire scores 4. Numeric rating scale score comparison 5. Investigation of radiation therapy dose, frequency, schedule, and medical history 6. Health-related quality of life questionnaire (EORTC-QLQ-C30) 7. Health-related quality of life measurement tool (EQ-5D) 8. Safety evaluation 9. Health-related quality of life measurement tool (EQ-5D)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 69 Years

Eligibility

Inclusion Criteria:

1. Between the ages of 19 and 69

2. Patients with biopsy confirmed invasive breast cancer

3. 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.

4. When lymph nodes are included in the required irradiation range

5. The Eastern Cooperative Oncology Group (ECOG) performance status 0-1

6. Those who understand the content of the study, agree to participate in the study, and provide written informed consent

Exclusion Criteria:

1. Subjects with distant metastases of cancer

2. Those whose cancer has invaded the skin of the breast (T4) or who have unhealed wounds on the skin

3. Patients who have a history of radiotherapy of the cervical thoracic region for other reasons in the past

4. Patients with a history of connective tissue disease

5. Subjects with uncontrolled diabetes with HbA1c 7.0 or higher

6. Pneumothorax and symptomatic upper respiratory tract infection

7. If it is judged that there will be a significant decrease in respiratory function

8. Undergoing treatments known to interact with hyperbaric oxygen therapy, such as cisplatin, doxorubicin, bleomycin, disulfiram, etc.

9. 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.

10. If it is determined that the life expectancy is not sufficient follow-up within 3 months.

11. Pregnant and lactating women

12. Other persons who are judged by the researcher to be unsuitable for research

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

Device:
• hyperbaric oxygen chamber
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).

Locations

Country	Name	City	State
Korea, Republic of	Lee Jee Young	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ilsan Cha hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of grade 2 or more dermatitis according to RTOG toxicity scale	? 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)	At the end of 6 month
Secondary	RTOG toxicity	? 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)	At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Secondary	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	At the end of Day 1, week 5, week 8, week 9, week 10
Secondary	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.	At the end of Day 1, week 5, week 8, week 9, week 10
Secondary	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.	At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Secondary	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.	At the end of Day 1, week 5, week 8, week 9, week 10
Secondary	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.	At the end of Day 1, week 5, week 8, week 9, week 10
Secondary	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.	At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Secondary	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.	At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10