A Randomised Clinical Trial to Compare the Efficacy of Hyperbaric Oxygen Therapy with Neoadjuvant Chemotherapy with Neoa
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ORIGINAL ARTICLE
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 Rijuta Aphale 1
&
Samir M. Shah 1
Received: 13 May 2020 / Accepted: 18 September 2020 # Association of Surgeons of India 2020
Abstract 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 Keywords Breast carcinoma . Hyperbaric oxygen therapy . Neoadjuvant therapy . Breast carcinoma . Complete pathological remission . Margins of excision
Introduction The carcinoma of the female breast continues to be a major cause of mortality and morbidity worldwide [1, 2]. Incidence of breast cancer is rising, particularly among younger females. Radical breast surgeries are associated with significant psychological trauma in females, with poor results in terms of Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12262-020-02601-4) contains supplementary material, which is available to authorized users. * Rijuta Aphale [email protected] Samir M. Shah [email protected] 1
Department of General Surgery, Government Medical College and Sir Takhtasinhji Hospital, Bhavnagar 364001, India
metastasis and recurrence, even so for the chemotherapy and radiotherapy resistant tumours. Neoadjuvant chemotherapy can reduce the tumour bulk or downstage the tumour but the results have not been satisfactory [3, 4]. Hypoxia plays a major role in cell survival, angiogenesis, glycolytic metabolism and meta
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