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

February 10, 2025 updated by: Kun Wang, Guangdong Provincial People's Hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangdong Provincial People's Hospital
        • Contact:
        • Contact:
          • Joey zhuang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.
  4. Patients who meet the inclusion criteria of neoadjuvant therapy to receive neoadjuvant therapy for breast cancer (locally advanced breast cancer (AJCC Stage III, except T3N1M0), or operable, but do not meet the conditions of breast conservation or axillary preservation (Stage IIA-IIB and T3N1M0).
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RCB 0/1 rate
Time Frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)

Secondary Outcome Measures

Outcome Measure
Time Frame
The Miller and payne classification
Time Frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
Side effects of hyperbaric oxygen therapy
Time Frame: during the hyperbaric oxygen therapy (up to half a year)
during the hyperbaric oxygen therapy (up to half a year)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: through study completion ( an average of half a year)
through study completion ( an average of half a year)
pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients
Time Frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
the Tumor immune microenvironment of the Hyperbaric Oxygen Therapy and neoadjuvant therapy
Time Frame: the time when the patient enrollment, at the end of the first cycle of neoadjuvant therapy (at about the first month) , surgery
the time when the patient enrollment, at the end of the first cycle of neoadjuvant therapy (at about the first month) , surgery
RECIST criteria
Time Frame: 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)
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)
Time Frame: At the time of patient enrolment, Each cycle of chemotherapy (8 cycle, each cycle is 3 weeks) , Day before surgery, 3 months after surgery
At the time of patient enrolment, Each cycle of chemotherapy (8 cycle, each cycle is 3 weeks) , Day before surgery, 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2024-1084-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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