To see the response of chemotherapy if given along with oxygen therapy in breast cancer patients .

Molecular characterization of hypoxia inducing factor (HIF) and angiogenic cytokine and their correlations with neoadjuvant chemotherapy in addition with hyperbaric oxygen therapy in breast cancer patients. - NACT

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062340

Enrollment

Registered

2024-02-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Hyperbaric Oxygen therapy along with NACT: Consecutive 3 cycles of hyperbaric oxygen therapy in graded pressure will be given along with chemotherapy. Day 1: 1.74 ATA for 1 hour Day 2:

Eligibility

Inclusion criteria

Inclusion criteria: All female patients of invasive breast carcinoma (Early or Locally advanced) planned for neoadjuvant chemotherapy

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Presence or absence of complete pathological remission in histopathological specimen of definitive surgery with no demonstrable invasive tumour cells. Assessment of pathological complete response (pCR) will be by (10-12)– a) Miller Payne grading b) Residual Cancer Burden (RCB) score.Timepoint: After Surgery (No Specific time)	—

Secondary

Measure	Time frame
1- Tumour down-staging by ultrasound evaluation of largest dimension of the tumour. 2-Lymph node status before & after therapy by clinical & ultrasound evaluation. 3-Cost effectivenessTimepoint: Baseline & after 2nd Chemotherapy	—

Countries

India

Contacts

Public ContactDr Pritam Yadav

Aiims New Delhi

drkamalkataria@gmail.com9212678920

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026