A Phase II Single-Arm Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Triple-Negative and HER2+ Breast Cancer Patients

NCT06825975 | Not Yet Recruiting

• 1 other identifier: KY2024-1118-02
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to explore the efficacy and safety of hyperbaric oxygen therapy in the neoadjuvant treatment of triple-negative and HER2+ breast cancer patients

Conditions

Breast Cancers

Outcome Measures

Primary Outcomes (1)

• pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients

  After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)

Secondary Outcomes (7)

• The Miller and payne classification

  After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)

• RCB 0/1 rate

  After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)

• RECIST criteria

  After completion of the first cycle of neoadjuvant therapy (at about 1 month), After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)

• Life quality (EORTC QLQ C-30、EORTC QLQ BR-23 questionnaire)

  At the time of patient enrolment, Each cycle of chemotherapy (8cycle, each cycle is 3 weeks) , Day before surgery, 3 months after surgery.

• Side effects of hyperbaric oxygen therapy

  during the hyperbaric oxygen therapy (up to half a year)

Study Arms (1)

Hyperbaric Oxygen group

EXPERIMENTAL

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).

Device: Hyperbaric oxygen treatment

Interventions

Hyperbaric oxygen treatment 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).

Hyperbaric Oxygen group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Understand the study process, participate in the study voluntarily, and sign the informed consent form.
• have an initial histopathologically confirmed diagnosis of unilateral primary invasive breast cancer, excluding occult breast cancer, inflammatory breast cancer and eczema-like carcinoma
• aged ≥ 18 years and ≤ 60 years, female
• ECOG performance status 0-1.
• LVEF ≥ 55%
• 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 ≥90 g/L;
• 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
• 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 the study treatment

You may not qualify if:

• Contraindication to hyperbaric oxygen therapy: untreated pneumothorax. Concurrent use of disulfiram. concomitant administration of anti-tumour drugs such as bleomycin, cisplatin, adriamycin concomitant administration of antineoplastic drugs such as bleomycin, cisplatin, adriamycin. Premature and/or low body mass neonates. Lung disease (severe chronic obstructive pulmonary disease). Diseases of the lungs (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infections, uncontrolled asthma, uncontrolled diarrhoea). controlled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear disease (eustachian tube Dysfunction of the eustachian tube, recurrent episodes of vertigo), ocular disease (retinal detachment).
• previous hyperbaric oxygen therapy.
• distant metastases, including lymph node metastases to the contralateral breast and mediastinum.
• other malignant tumours within the last two years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix. Tumour.
• pregnancy or lactation
• uncontrolled hypertension, cardiac, hepatic, renal related disease or other medical or psychiatric conditions.
• major surgical procedure unrelated to breast cancer within 4 weeks prior to randomisation, or the patient has not fully recovered from such procedure; or has not fully recovered from such surgical intervention.
• serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to Serious or uncontrolled infections that may interfere with study treatment or the evaluation of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positivity, and pulmonary infections.
• recent history of thromboembolism and taking full dose anticoagulant medication.
• any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Kun wang

CONTACT

86+13829694500; gzwangkun@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 13, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-01

Locations

CN (1)