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

NCT06825949 | Not Yet Recruiting

• 1 other identifier: KY2024-1084-02
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• RCB 0/1 rate

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

Secondary Outcomes (7)

• 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)

• The Miller and payne classification

  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 adjuvant therapy, 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 (8 cycle, 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:

• understood the study process, volunteered to participate in this study and signed an informed consent form
• Patients with histopathologically confirmed diagnosis of initial unilateral primary invasive breast cancer, occult breast cancer, Inflammatory breast cancer and eczema-like carcinoma are excluded.
• Female, aged ≥ 18 years and ≤ 60 years.
• Hormone receptor-positive breast cancer (Luminal/HER2-low (IHC 2+/FISH-negative)).
• ECOG performance status 0-1.
• LVEF ≥ 55 per cent
• 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;
• 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 study treatment

You may not qualify if:

• 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).
• Previous hyperbaric oxygen therapy.
• Distant metastases, including lymph node metastases in the contralateral breast and mediastinum.
• Malignancy other than radically treated basal or squamous cell carcinoma of the skin or CIS of the uterine cervix within the last two years.
• Pregnancy or lactation.
• Uncontrolled hypertension, cardiac, hepatic, renal related diseases or other medical or psychiatric disorders.
• Major surgical procedures unrelated to breast cancer within 4 weeks prior to randomisation, or patients who have not fully recovered from such surgical procedures.
• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 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: Professor

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 13, 2025
• Study Start: February 15, 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)