BACKGROUND: Patients receiving chemoradiotherapy (CRT) for oral cancer (OC) often develop oral mucositis (OM). OM associated pain severely affects oral functions and nutrition of the patient, resulting in narcotic analgesic use and CRT interruption. Laser therapy has shown some promising results in preventing and treating OM caused by cancer therapies. So in this trial we used prophylactic Low Level Helium Neon (He-Ne) Laser for the prevention and treatment of CRT induced OM in OC patients. MATERIALS AND METHODS: This double blinded trial block randomized 121 primary OC patients scheduled to undergoCRT [RT dosage=66 Gray/33 fractions for 5 days/week and chemotherapy (3 weekly Cisplatin)] into laser (n=60) and placebo (n=61) group. Laser group received He-Ne Laser (λ=632.8 nm, P=24 mW, ED=3.5 J/cm(2)) while placebo received sham treatment just before radiation for 6.5 weeks. OM (RTOG/EORTC Scale), its associated pain, and total parenteral nutrition (TPN), were assessed on every week by a blinded assessor. Also opioid analgesic use, weight loss and any CRT break were recorded. Data was analyzed using descriptive statistics, t-test and Man Whitney U test. Level of significance was set at p<0.05. RESULTS:Incidence of severe OM (29% vs. 89%, p<0.001) and its associated pain (18% vs. 71%, p<0.001), opioid analgesic use (7% vs. 21%, p<0.001)and TPN (30% vs. 39% p=0.039) was significantly less in laser than placebo group patients. Also duration of severe OM and pain experienced was less in laser than placebo group. CRT break required only for placebo group (9%) patients. CONCLUSION:Low Level He-Ne Laser decreased the incidence of CRT induced severe OM and its associated pain, opioid analgesics use and TPN.
RCT Entities:
BACKGROUND:Patients receiving chemoradiotherapy (CRT) for oral cancer (OC) often develop oral mucositis (OM). OM associated pain severely affects oral functions and nutrition of the patient, resulting in narcotic analgesic use and CRT interruption. Laser therapy has shown some promising results in preventing and treating OM caused by cancer therapies. So in this trial we used prophylactic Low Level Helium Neon (He-Ne) Laser for the prevention and treatment of CRT induced OM in OC patients. MATERIALS AND METHODS: This double blinded trial block randomized 121 primary OC patients scheduled to undergo CRT [RT dosage=66 Gray/33 fractions for 5 days/week and chemotherapy (3 weekly Cisplatin)] into laser (n=60) and placebo (n=61) group. Laser group received He-Ne Laser (λ=632.8 nm, P=24 mW, ED=3.5 J/cm(2)) while placebo received sham treatment just before radiation for 6.5 weeks. OM (RTOG/EORTC Scale), its associated pain, and total parenteral nutrition (TPN), were assessed on every week by a blinded assessor. Also opioid analgesic use, weight loss and any CRT break were recorded. Data was analyzed using descriptive statistics, t-test and Man Whitney U test. Level of significance was set at p<0.05. RESULTS: Incidence of severe OM (29% vs. 89%, p<0.001) and its associated pain (18% vs. 71%, p<0.001), opioid analgesic use (7% vs. 21%, p<0.001)and TPN (30% vs. 39% p=0.039) was significantly less in laser than placebo group patients. Also duration of severe OM and pain experienced was less in laser than placebo group. CRT break required only for placebo group (9%) patients. CONCLUSION: Low Level He-Ne Laser decreased the incidence of CRT induced severe OM and its associated pain, opioid analgesics use and TPN.
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