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#Spss version 25 citation in jama trial#
8 – 10 We therefore hypothesized that oral cryotherapy delivered during oxaliplatin infusion would reduce the intensity and duration of OTH by limiting chemotherapy delivery to the oral mucosa.Ī single-institution, randomized, controlled trial was conducted to evaluate the efficacy of oral cryotherapy during oxaliplatin infusion as a preventive measure against OTH. In addition, several clinical trials have shown that oral cryotherapy reduces mucositis in patients with cancer receiving 5-fluorouracil–based chemotherapy or high-dose melphalan before hematopoietic stem cell transplant. In another trial by Hanai et al, 7 the application of a limb-cooling device to one hand during paclitaxel infusion reduced the development of peripheral neuropathy (PN) compared with the untreated hand. A randomized trial by Nangia et al 6 showed that the application of a “cold cap” during chemotherapy infusion reduced alopecia up to 50% in patients with breast cancer.
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4 Recently, it has been shown that cooling of anatomic areas during chemotherapy infusion can reduce toxicity to those regions, presumably because of local vasoconstriction. 3 – 5 OTH is known to reduce quality of life, and no established strategies exist to prevent this toxicity. 1, 2 A unique and common toxicity of oxaliplatin is oral thermal hyperalgesia (OTH), a form of acute neuropathy caused by disruption of voltage-gated Na + channels that leads to hyperexcitability of cold-sensing sensory nerves. Oxaliplatin is a commonly used chemotherapy for patients with gastrointestinal cancers. Conclusions: Oral cryotherapy is a tolerable and cost-effective method of diminishing OTH in patients receiving oxaliplatin chemotherapy, and seems to be most effective in the early stages of treatment. Duration of ice chip exposure was associated with improved oral symptoms over time ( P=.02). No difference in oral symptoms over time was seen between the intervention and control groups ( P=.20), although a high attrition rate was noted. The magnitude of difference in symptom scores before versus after the first treatment cycle was significantly less in the intervention versus control arm ( P=.001). The rate of patients with oral symptoms after the first treatment cycle was significantly lower in the intervention arm (n=8 32%) than in the control arm (n=18 72%), meeting the primary study objective ( P=.01). Results: Of 62 randomized patients with a variety of gastrointestinal malignancies, 50 (25 per treatment arm) were evaluable for efficacy.
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Evaluable patients were those who had completed at least 2 cycles of oxaliplatin therapy. Those in the treatment arm were asked to document how long they kept the ice chips in their mouths (0, <30, 30, 60, 90, or 120 minutes) and to report their discomfort associated with oral cryotherapy. All patients completed baseline questionnaires regarding oral and peripheral symptoms and on-treatment questionnaires on day 1 of each subsequent chemotherapy cycle. Methods: Patients with gastrointestinal cancer treated with biweekly oxaliplatin (85 mg/m 2 over 120 minutes) at Abramson Cancer Center at the University of Pennsylvania were randomized to receive oral cryotherapy (ice chips) during oxaliplatin infusion or standard-of-care treatment. This study evaluated the efficacy of oral cryotherapy in preventing OTH during oxaliplatin chemotherapy infusion. Background: Chemotherapy-induced oral thermal hyperalgesia (OTH) is a common and debilitating side effect of platinum-based anticancer agents.