Background
Randomized controlled trials (RCT) of scalp cooling (SC) to prevent chemotherapy induced alopecia (CIA) did not evaluate its effect on hair regrowth (HR) and was conducted in a predominantly taxane (T) treated population. We conducted an RCT of SC in a setting of anthracycline (A) and taxane chemotherapy (CT) and assessed its effect on CIA and HR.
Methods
Non-metastatic breast cancer women undergoing (neo) adjuvant CT were randomized to receive SC using the Paxman scalp cooling system during every cycle of CT, or no SC. The primary end point (PEP) was successful hair preservation (HP) assessed clinically and by review of photographs after CT. HR was assessed at 6 and 12 weeks.
Results
51 patients were randomized to SC (34) or control arm (17) in a 2:1 ratio. Twenty-five (49%) patients received A followed by T and the two arms were balanced with respect to this factor. HP rate was significantly higher in SC arm compared to control arm (56.3% vs 0%, P = 0.000004). HR was higher in SC arm compared to control at 6 weeks (89% vs 12%; P < 0.001) and 12 weeks (100% vs 59%, P = 0.0003). Loss of hair at PEP evaluation, which was a quality of life measure, was significantly lower in SC versus control arm (45% vs 82%, P = 0.016). There were no grade 3–4 cold related adverse effects.
Conclusions
Women with breast cancer receiving A or T chemotherapy receiving SC were significantly more likely to have less than 50% hair loss after CT, superior hair regrowth and improvement in patient reported outcomes, with acceptable tolerance. It merits wider usage.
Aim:The aim is to translate and validate the European Organization for Research and Treatment for Cancer (EORTC) ovarian cancer (OC) module (OV-28) into Hindi and Marathi to use for patients and scientific community.Methods and Results:The EORTC OV-28 was translated into Hindi and Marathi languages using prescribed guidelines by the EORTC. The process included forward translation by four translators (2 each for Hindi and Marathi). The questionnaires obtained were then given to independent backward-translators who then translated them back into English. These 2 questionnaires were then compared with the original EORTC questionnaire and the second intermediate questionnaires were formed. The second intermediate questionnaire was subsequently administered in twenty patients (10 each for Hindi and Marathi) diagnosed with OC who had never seen the questionnaire before, for pilot testing. Each of these ten patients after filling up the questionnaire themselves was then interviewed for any difficulty encountered during the filling up of the questionnaires. These were in the form of specific modules including difficulty in answering, confusion while answering, and difficulty to understand, whether the questions were upsetting and if patients would have asked the question in any different way. The suggestions were incorporated into the second intermediate questionnaires to form the final Hindi and Marathi ON-28 questionnaires. These questionnaires were then sent to the EORTC for the final approval to be used in clinical studies.Conclusion:We have successfully translated EORTC OV-28 module into Hindi and Marathi languages, and EORTC approved them to be used in clinical practice and studies for OC patients.
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