A Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Hormone Receptor Positive Breast Cancer Patients

NCT ID: NCT06825949

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2026-12-31

Brief Summary

The goal of this study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of hormone receptor positive breast cancer patients

Conditions

Breast Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyperbaric Oxygen group

Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, with a minimum of 5 times hyperbaric oxygen treatments per chemotherapy cycle, one per day for 60-90 minutes, for a total of 30-40 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA).

Group Type: EXPERIMENTAL

Hyperbaric oxygen treatment

Intervention Type: DEVICE

Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, with a minimum of 5 hyperbaric oxygen treatments per chemotherapy cycle, one per day for 60-90 minutes, for a total of 30-40 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA).

Interventions

Hyperbaric oxygen treatment

Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, with a minimum of 5 hyperbaric oxygen treatments per chemotherapy cycle, one per day for 60-90 minutes, for a total of 30-40 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. understood the study process, volunteered to participate in this study and signed an informed consent form

2. Patients with histopathologically confirmed diagnosis of initial unilateral primary invasive breast cancer, occult breast cancer, Inflammatory breast cancer and eczema-like carcinoma are excluded.

3. Female, aged ≥ 18 years and ≤ 60 years.

5. Hormone receptor-positive breast cancer (Luminal/HER2-low (IHC 2+/FISH-negative)).

6. ECOG performance status 0-1.

7. LVEF ≥ 55 per cent

8. Adequate bone marrow functional reserve: white blood cell count ≥ 3.0 x 109/L, neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; haemoglobin ≥ 90g/L;

9. AST, ALT ≤ 2.5 times the upper limit of normal value, alkaline phosphatase ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value

10. For non-menopausal or non-surgically sterilised female patients: consent to contraception during treatment and for at least 7 months after the last dose of study treatment

Exclusion Criteria

1. have contraindications to hyperbaric oxygen therapy: lung disease (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infections, uncontrolled asthma, untreated pneumothorax), previous history of middle ear surgery, middle ear disease (eustachian tube dysfunction\recurrent vertigo), eye disease (retinal detachment).

2. Previous hyperbaric oxygen therapy.

3. Distant metastases, including lymph node metastases in the contralateral breast and mediastinum.

4. Malignancy other than radically treated basal or squamous cell carcinoma of the skin or CIS of the uterine cervix within the last two years.

5. Pregnancy or lactation.

6. Uncontrolled hypertension, cardiac, hepatic, renal related diseases or other medical or psychiatric disorders.

7. Major surgical procedures unrelated to breast cancer within 4 weeks prior to randomisation, or patients who have not fully recovered from such surgical procedures.

8. Serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positivity, pulmonary infection, or other infections.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kun Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Kun wang

Role: CONTACT

gzwangkun@126.com

86+13829694500

Facility Contacts

Kun Wang

Role: primary

gzwangkun@126.com

13922118086

Joey zhuang

Role: backup

Other Identifiers

KY2024-1084-02

Identifier Type: -

Identifier Source: org_study_id