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

ABSTRACT

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.