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

ConditionBreast Cancers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorGuangdong Provincial People's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: Hyperbaric Oxygen groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RCB 0/1 rate

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

Secondary outcomes

1

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)
2

The Miller and payne classification

Time frame
After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
3

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)
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: