A prospective study to evaluate pelvic bone mineral density changes in patients of cervical cancer undergoing chemoradiotherapy: study protocol

Background:Cancer treatment induced bone loss has been retrospectively studied as a distinct entity in gynaecological cancers. Amongst gynaecological cancers, cervical cancer is the leading cause of mortality and morbidity, majorly in developing countries. Concurrent chemoradiation (CCRT) is considered as the standard of care in managing these patients. Persistent low back ache is often reported as a potential post treatment sequalae by long term survivors of cervical malignancy. Various retrospective studies done have observed reduced density and osteopenia of the bones in the irradiated area, as a possible etiologic factor for persistent low back ache.Methods:We in this prospective clinical trial propose to prospectively and systematically evaluate the changes in pelvic bone density in patients of cervical cancer receiving chemoradiotherapy using dual energy X-ray absorptiometry (DEXA) scan done pre and post treatment, and correlate the changes with occurrence and severity of persistent low back ache.Low back ache will be evaluated using Oswestry low back pain disability scale, scoring for which shall be done pre-treatment and then at post treatment at 2 monthly interval for 1 year on follow up. Conclusions: Results from the trial might bring-forth the changes in the density of pelvic bones in patients of cancer cervix undergoing concurrent chemoradiation and its correlation with low back ache, if any.Trial Registration: This trial is registered with number CTRI/2017/05/008606.

Study on association of polymorphism of CYP450 2D6 with head and neck cancer and treatment response in patients receiving neoadjuvant chemotherapy paclitaxel, cisplatin, 5fu (TPF) followed by chemoradiation.

Background: Aims of this study were to study the association of genetic polymorphism in CYP450 2D6 in patients of locally advanced head and neck cancer, and try to assess a correlation between this polymorphism & response to treatment. Need of the study was to find out a possible genetic level explanation for the different response achieved in patients with similar histopathology, stage, exposure to carcinogen & ethnicity undergoing similar treatment. Methods: A study comprising of 150 patients & 150 controls was done to analyze the association between polymorphs of CYP450 2D6 with head & neck cancer and treatment response (TPFCTRT). Two cycles of TPF (paclitaxel-175mg/m2 D1, cisplatin 35mg/m2 D2-D3 and 5Fu 1gm/m2 D1-D3) were given followed by radiotherapy with concurrent cisplatin (40 mg/m2).The response to the treatment was assessed clinically, radiologically & by laryngoscopy-post treatment. Genotyping of the blood samples was done. Analysis of the association between genetic polymorphisms and risk of HNSCC was estimated by calculating crude odds ratio (OR). A P value of <0.05 was considered statistically significant. The statistical analysis was performed with the SPSS software package (version 11.0 for Windows; SPSS Chicago, IL). Results: Patients with CYP 2D6*1 showed good response to the therapy given, while CYP 2D6*4 and *10 were poor responders. Conclusion: There is a strong association of polymorphs of CYP 2D6 with occurrence of head and neck cancer. Response to treatment (TPFCT-RT) is polymorph graded. Our study thus provides an insight in to the concept of “Right therapy to the right patient”.