NCT06825949尚未招募不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- RCB 0/1 rate
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •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).
- •Hormone receptor-positive breast cancer (Luminal/HER2-low (IHC 2+/FISH-negative)).
- •ECOG performance status 0-
- •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
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Hyperbaric oxygen treatment (Device)
结局指标
主要结局
RCB 0/1 rate
时间窗: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
次要结局
- The Miller and payne classification(After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year))
- 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))
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(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))
- the Tumor immune microenvironment of the Hyperbaric Oxygen Therapy and neoadjuvant therapy(the time when the patient enrollment, at the end of the first cycle of neoadjuvant therapy (at about the first month) , surgery)
研究者
Kun Wang
Professor
Guangdong Provincial People's Hospital
研究点 (1)
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