To see the response of chemotherapy if given along with oxygen therapy in breast cancer patients .
Phase 3
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2024/02/062340
- Lead Sponsor
- Aiims New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All female patients of invasive breast carcinoma (Early or Locally advanced) planned for neoadjuvant chemotherapy
Exclusion Criteria
1. Pregnant women
2. Lactating women
3. Contraindication to HBOT -
a. middle ear infections
b. eustachian tube blockage
c. chronic obstructive pulmonary disease
d. emphysema
4. Contraindication to systemic chemotherapy
5. Poor performance score
6. Significant co-morbidities
7. Women refusing consent.
8. >4 organs involved in metastasis not amenable to resection
9. Recurrent breast cancer
10. Inflammatory breast cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence or absence of complete pathological remission in histopathological specimen of definitive surgery with no demonstrable invasive tumour cells. <br/ ><br>Assessment of pathological complete response (pCR) will be by (10-12)– <br/ ><br> a) Miller Payne grading <br/ ><br> b) Residual Cancer Burden (RCB) score.Timepoint: After Surgery (No Specific time)
- Secondary Outcome Measures
Name Time Method 1- Tumour down-staging by ultrasound evaluation of largest dimension of the tumour. <br/ ><br>2-Lymph node status before & after therapy by clinical & ultrasound evaluation. <br/ ><br>3-Cost effectivenessTimepoint: Baseline & after 2nd Chemotherapy