Reusable Cryotherapy Mouthpiece Reduces Oral Pain, Analgesic Use During Chemotherapy
Results from a prospective study demonstrate that Chemo Mouthpiece, a self-contained, reusable, intra-oral cryotherapy device significantly reduces oral pain and analgesic use in patients receiving cytotoxic chemotherapy.
“Oral mucositis is an untoward side effect of many forms of cytotoxic chemotherapy” that has limited treatment options, stated Richard Zuniga, MD, New York Cancer and Blood Specialists, Port Jefferson Station, New York, and coauthors. “Cryotherapy is an effective mucositis intervention for selected chemotherapy regimens, but reliance on ice chips has limited its applicability.”
This multi-center study randomized 164 patients on a 2-to-1 basis to receive either Chemo Mouthpiece plus best supportive care (n = 110) or best supportive care alone (n = 54). Patients recorded daily oral pain scores (on a scale of 0 to 5) and analgesic use via questionnaires during 2 chemotherapy cycles that were approximately 14 days each. Tolerability was assessed in the Chemo Mouthpiece arm at study completion.
At analysis, oral pain was reported at 17.8% of visits in patients who received Chemo Mouthpiece and at 24.6% of visits in patients who received best supportive care (P < .001). Analgesics were required for 11.3% of patients who received Chemo Mouthpiece and 26% of patients who received best supportive care (P = .01). On a scale of 0 to 10 with 10 representing “completely agree,” there was a mean score of 6.8 for device comfort, and 8.3 for whether patients would recommend the device to other patients undergoing chemotherapy. No safety issues related to the device were reported. Early discontinuation rates were initially higher in the Chemo Mouthpiece arm and attributed to device fit but declined after the use of smaller-sized models which was introduced after the first 30 patients were screened.
As Dr Zuniga et al concluded, “the device was an effective, well-tolerated, convenient surrogate for ice and provided an alternative platform for the delivery of a consistent course of cryotherapy for patients at [oral mucositis] risk.”
Source:
Zungia R, Dembla V, Alam N, et al. Multi-institutional, randomized, controlled trial to assess the efficacy and tolerability of a reusable, self-contained cryotherapy delivery device. Support Care Cancer. Published online: July 31, 2025. doi:10.1007/s00520-025-09795-x
