FDA-Cleared Chemo Mouthpiece Reduces Oral Pain by 46% and Opioid Use by 68% in Pivotal Cancer Trial
核心洞察
The Chemo Mouthpiece (搜索), an FDA 510(k) cleared intraoral cryotherapy device, demonstrated a 46% reduction in patient-reported oral pain and 68% reduction in opioid or analgesic use during chemotherapy in a multi-center randomized controlled trial.
The pivotal study enrolled 164 patients across 16 U.S. sites and showed efficacy across more than 30 chemotherapy regimens and 17 cancer types, with 83% of patients indicating they would recommend the device.
Published in Supportive Care in Cancer, the trial results validate the device as a safe and effective alternative to traditional ice chip cryotherapy for managing oral mucositis, a painful side effect affecting up to 80% of chemotherapy patients.
A novel FDA-cleared medical device has demonstrated significant efficacy in reducing chemotherapy-induced oral pain and opioid dependence, according to peer-reviewed results from a pivotal multi-center trial published in Supportive Care in Cancer, the official journal of the Multinational Association of Supportive Care in Cancer (MASCC).
The Chemo Mouthpiece (搜索)®, developed by Chemomouthpiece, LLC (搜索), showed a 46% reduction in patient-reported oral pain symptoms and a 68% reduction in opioid or analgesic use compared to standard care alone in the randomized controlled trial involving 164 patients across 16 U.S. study sites.
Clinical Trial Results Demonstrate Broad Efficacy
The study, titled "Multi-institutional, randomized, controlled trial to assess the efficacy and tolerability of a reusable, self-contained cryotherapy delivery device," evaluated the device's performance across more than 30 chemotherapy regimens and 17 cancer types. Patients were randomized in a 2:1 ratio to receive either the Chemo Mouthpiece (搜索) plus best supportive care (110 patients) or best supportive care alone (54 patients).
In the intention-to-treat population, 17.8% of patients using the Chemo Mouthpiece (搜索) reported mucosal pain during cycles 1 and 2 compared to 24.6% in the control group (P <.001). The per-protocol analysis showed even more pronounced benefits, with 12.8% versus 23.9% reporting pain (P <.001).
Longitudinal analysis revealed that peak symptoms typically occurred between days 4 and 10 of each cycle, with patients using the device consistently remaining pain-free compared to the control arm (P = .068).
Significant Reduction in Analgesic Dependence
The trial demonstrated substantial reductions in analgesic use across multiple measures. In the intention-to-treat population, 26% of control patients required analgesics during the first two cycles compared to only 11.3% of device users (P = .01). For study visits specifically, 7.7% of control patients versus 1.8% of Chemo Mouthpiece (搜索) users reported analgesic use (P <.001).
"The data from this rigorous, multi-center trial clearly validate the Chemo Mouthpiece (搜索) as a safe and effective tool for addressing oral mucositis-related pain and related opioid use," said Richard Zuniga, MD, Medical Chief of Research at New York Cancer and Blood Specialists (搜索) and lead study investigator. "The scope of chemotherapy regimens and cancer types included in the study underscores the potential to benefit the diverse patient population impacted by oral mucositis."
Addressing a Critical Unmet Need
Oral mucositis affects up to 80% of chemotherapy patients, depending on cancer type, and represents a significant clinical challenge. The condition is characterized by inflammation and ulceration of the mucous membranes in the mouth, interfering with patients' ability to eat, drink, speak, and sleep. Clinical impacts include delays or dose reductions in cancer therapy, increased infection risk, significant weight loss, greater dependence on opioids, and higher rates of emergency room visits and hospitalizations.
Traditional cryotherapy using ice chips, while established as a mitigation strategy, presents practical challenges for patients and care teams. "Cryotherapy is a well-established strategy for mitigating oral mucositis, but its traditional delivery using ice chips presents practical challenges," explained Stephen Sonis, DMD, DMSc, Senior Lecturer in Oral Medicine at the Harvard School of Dental Medicine and senior faculty member at Dana-Farber Cancer Institute and Brigham and Women's Hospital.
Device Design and Patient Experience
The Chemo Mouthpiece (搜索) is a self-contained cryotherapy device designed to cool the entire oral cavity during and after chemotherapy infusion. By inducing vasoconstriction in the oral cavity, the device reduces local presence of chemotherapy drugs, helping to mitigate mucosal injury. The device is reusable, pre-filled with filtered water and a proprietary saline solution, and made of durable, medical-grade silicone.
Unlike traditional oral cryotherapy approaches typically recommended only for chemotherapy drugs with short half-lives during infusion, this trial included regimens with both short and long half-life agents. The device's portability and user-friendly design enabled patients to continue use at home when chemotherapy agents may still be circulating, contributing to improved efficacy across various regimens.
Patient satisfaction was notably high, with 83% indicating they would recommend the device to other patients undergoing chemotherapy. End-of-study questionnaire responses ranged from 6.8 for device comfort to 9.3 for clarity of patient instructions, with the recommendation question averaging 8.3 on a 10-point scale.
Safety Profile and Regulatory Status
The device demonstrated an excellent safety profile with no reported safety issues during the trial. The FDA awarded the Chemo Mouthpiece (搜索) Breakthrough Device Designation in December 2021, and the device received FDA 510(k) clearance in January 2024. It is available by prescription only and indicated for use in cooling the oral mucosa to reduce the incidence and severity of chemotherapy-induced oral mucositis in adult patients.
Cancer Survivor-Driven Innovation
The device was developed by company founder and CEO David Yoskowitz, a cancer survivor who experienced firsthand the debilitating effects of oral mucositis. His personal experience with inadequate treatment options, including ice chips that caused nausea and failed to effectively cool the entire oral cavity, led him to engineer an improved solution.
"This study is not just a scientific milestone, it's deeply personal," said Yoskowitz. "It's incredibly rewarding to see the clinical data confirm the device's impact on pain reduction and patient quality of life. Not only for me, but for our original goal, to help reduce the suffering associated with oral mucositis for every at-risk patient."
The study enrolled patients aged 18 to 80 years planning to receive at least two cycles of infused stomatotoxic chemotherapy regimens, with broad inclusion criteria regarding regimen type and primary tumor diagnosis. Patients receiving oxaliplatin were excluded due to known cold sensitivity associations, as were those planning concomitant radiotherapy or dependent on opioid analgesia.