A Randomised Clinical Trial to Compare the Efficacy of Hyperbaric Oxygen Therapy with Neoadjuvant Chemotherapy with Neoadjuvant Chemotherapy Alone for Carcinoma Breast: a Pilot Study

Hypoxia plays a major role in cell survival, angiogenesis, glycolytic metabolism and metastasis in breast cancer. Hyperbaric oxygen therapy (HBOT) has a well-established effect for attenuating the effects of hypoxia by enhancing the effects of chemotherapy drugs and increasing oxygen delivery to the tissues. The hypoxic environment encourages cancer cells to acquire stemness and become resistant to chemotherapeutic drugs. We have used HBOT as an adjunct to neoadjuvant chemotherapy in breast cancer patients with the objective of reducing tumour hypoxia and improving the response to chemotherapy. A randomised controlled trial was conducted in patients with breast cancer. The patients were randomly allocated into the study group receiving neoadjuvant chemotherapy (NAC) with HBOT and the control group who received NAC only. The NAC consisted of 3 cycles of intravenous injection of cyclophosphamide, 5-fluorouracil and epirubicin. The HBOT was administered along with the chemotherapy in 3 sessions in each cycle at graded pressures in each sessions. Ultrasound evaluation of patients was carried out and breast tumour size was measured after every cycle of HBOT. All the patients were operated after 3 cycles of chemotherapy and modified radical mastectomy was carried out. The response of therapy was recorded in both the groups. Patients receiving HBOT achieved significantly higher percentage reduction of tumour volume (43.1%) and the largest dimension (80.21%) (p< 0.0001) compared with those receiving chemotherapy alone. Trial registry: CTRI/2019/03/018258