Mouthpiece for Chemotherapy Induced Oral Mucositis in Cancer Patients
A Randomized, Prospective, Multi-center Trial to Assess the Efficacy of a Cryotherapy Device Versus est Supportive Oral Care in Mitigating Symptoms of Oral Mucositis in Patients Receiving Chemotherapy for the Treatment of Cancer
This is a study to evaluate the efficacy of Chemo Mouthpiece® in minimizing patient-reported symptoms associated with oral mucositis in cancer patients receiving chemotherapy. The Chemo Mouthpiece(R) is a novel device to make it easier to deliver cryotherapy (ice chips).
This is a post-market, randomized, prospective, multi-center study conducted to assess the
efficacy and utility of a novel oral cryotherapy delivery device in mitigating symptoms
associated with chemotherapy-induced oral mucositis in patients being treated with standard
stomatotoxic chemotherapy regimens.
Cryotherapy delivered by ice chips has been advocated for patients at risk for oral mucositis
for years and data from clinical trials support its utility. It is hypothesized that the cold
imparted by ice causes vasoconstriction and so limits the accumulation of stomatotoxic drug
within the oral mucosa.
However, the inconvenience of using ice chips repeatedly and over extended periods of time
has been limiting for patients. Chemo MouthpieceTM is a novel device created to facilitate the
easier and more controlled delivery of cryotherapy to patients at risk of oral mucositis.
Aged 18-80 years
Planned to receive at least 2 cycles of infused stomatotoxic chemotherapy regimens
Be willing and able to complete all study-related activities
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the
contact information above or email email@example.com and someone will assist you.
Your information will be shared only with the research study team for recruitment purposes and designated CTSI personnel for project quality
assurance and will remain confidential. Your information will be stored indefinitely. Should you no longer want this information to be provided
in the aforementioned ways, please contact firstname.lastname@example.org.