The Chemo Mouthpiece® (“CMP”) is an oral cryotherapy device, intended to be used to cool the oral mucosa (the inside surfaces of the mouth) to reduce the occurrence and severity of chemotherapy-induced oral mucositis in adult patients. When placed in a standard freezer for at least six hours, the specially designed devices will have a frozen inner core and an outer chamber which will be a cold liquid. When placed in the mouth, the system works to deliver cryotherapy (cold temperature) throughout the oral cavity. The devices are for single-patient use and are reusable throughout your course of treatment.
The Chemo Mouthpiece® is available by prescription (Rx) only through your healthcare provider and is distributed in the USA by specialty healthcare service provider InfuSystem. The devices are supplied as a Patient Kit including six (6) pre-filled and reusable CMP devices, cooling packs, cleaning brushes, insulated sleeves, a carrying cooler and instructions for use.
Oral mucositis (OM) is a painful and debilitating side effect of many chemotherapy drugs. OM is characterized by inflammation and ulceration of mucous membranes in the mouth, which occurs when chemotherapy drugs attack and cause damage to those cells. These painful sores and ulcers can occur throughout the mouth including the hard and soft palate, tongue, gums, cheeks and lips.
Oral cryotherapy (temporarily cooling the inside of the mouth) restricts the flow of blood in that area. When chemotherapy drugs are circulating in the body, the restricted blood flow in the oral cavity means the chemotherapy drugs are physically limited from contact in that area. The reduced presence of chemotherapy drugs means a reduction in the damage they can cause to the sensitive lining of the mouth (the oral mucosal layer).
According to the Mayo Clinic Staff, “Chemotherapy and radiation — alone or combined — can cause mouth sores. That’s because these cancer treatments are intended to kill rapidly growing cells, such as cancer cells. Some healthy cells in your body also divide and grow rapidly, including the cells that line the inside of your mouth. Unfortunately, these healthy cells are also damaged by chemotherapy and radiation. Damage to the cells in your mouth makes it difficult for your mouth to heal itself and to fend off germs, leading to sores and infections. Both chemotherapy and radiation can impair your body’s germ-fighting system (immune system). With an impaired immune system, viruses, bacteria and fungi can more easily infect your mouth, causing mouth sores or making mouth sores worse.”
Oral mucositis is a common side effect of many different chemotherapy treatments, and a significant proportion of chemotherapy patients will experience some grade of OM. Many factors may affect the development and severity of oral mucositis, including but not limited to the specific chemotherapy regimen (type, dosages, frequency, cycle), patient age, oral health, and lifestyle factors.
The best way to protect yourself from the occurrence and severity of chemotherapy-induced oral mucositis is to be proactive in your approach and use the Chemo Mouthpiece from the very first chemotherapy infusion. The best efficacy has been shown when patients begin to use the Chemo Mouthpiece to cool the oral cavity starting 10 minutes prior to every chemotherapy infusion, use it throughout every infusion, and continue with additional oral cryotherapy sessions at home. See the full Instructions For Use for additional information, and be sure to discuss your specific therapy with your doctor.
Yes! Chemo Mouthpiece® was engineered by a cancer patient with the fellow patients in mind. It’s simple makeup of FDA medical grade silicone/plastic, water and salt assures patients it’s a safe and effective non-toxic device. Remember to follow proper care instructions to keep the device clean!
The inner chamber of the unit will stay frozen for 30+ minutes. If traveling with the unit in the provided insulated cooler, it can stay frozen for up to 8 hours! This allows patients to travel to and from treatment with a ready to go unit.
The device has four components which are all categorized as Generally Recognized As Safe (GRAS) by the FDA. The components are medical grade silicone, filtered water, HDPE plastic, and a proprietary saline solution.
Of course! That is one of the benefits of Chemo Mouthpiece® when compared to other forms of oral cryotherapy, it can be tolerated by those with sensitive teeth since the outer chamber is made of FDA-approved silicone (part that touches the teeth) isn’t frozen solid.
Six (6) Chemo Mouthpiece devices, 2 insulated sleeves, one cleaning brush, six reusable gel ice packs, one high quality insulated cooler with carrying strap, and instructions for use.
The devices are easy to clean with soap and warm water. The supplied cleaning brush should be used to clean inside the breathing tubes. Further directions are included in the Instructions For Use, which is included in the packaging and available on this website. There is no need for sterilization.
The device has two built-in breathing tubes to facilitate normal breathing. The device does not obstruct breathing through the nose, and patients using supplemental oxygen can still use a nasal cannula.
One size fits most adult patients.
No, the Chemo Mouthpiece® devices come pre-filled. They are self-contained and ready to be used once they are placed in a freezer for at least six hours and cleaned and re-used as needed.
If you are receiving treatment for any Head and Neck cancers, you must first discuss your specific treatment with your doctor to assess whether using the Chemo Mouthpiece® is appropriate during your treatment. Treatment for cancers in or near the oral cavity may preclude the use of oral cryotherapy and the CMP device due to the need for chemotherapy to reach the oral cavity. Patients being treated for Head & Neck cancer may be able to benefit from the Chemo Mouthpiece® as a palliative care device for oral pain and swelling after chemotherapy and/or radiation therapy has been completed.
CMP Patient Kits available by prescription (Rx) and are distributed in the USA by specialty healthcare service provider InfuSystem. The Patient Kit includes six (6) pre-filled and reusable CMP devices, cooling packs, cleaning brushes, insulated sleeves, a carrying cooler and instructions for use.
Yes. The Chemo Mouthpiece® was studied in a randomized, prospective, multi-center trial to assess the efficacy of the device versus best supportive oral care in mitigating symptoms of oral mucositis in adult patients receiving chemotherapy for the treatment of cancer. For trial design and information see: https://clinicaltrials.gov/study/NCT04595838.
The Chemo Mouthpiece® device demonstrated statistical significance of both co-primary endpoints, being the reduction in patient-reported oral pain and reduction in patient use of opioids & other analgesics. Compared to the control arm, pain scores were reduced by 46% (p-value <.001) and opioid & other analgesic use was reduced by 68% (p-value <.001).
Patients were instructed to use the device for 10 minutes prior to the start of every chemotherapy infusion, throughout the entire time of infusion and continue for an additional 10 minutes after infusion completion. A fresh, frozen device was substituted every 30 minutes throughout the infusion period. Patients were instructed to use the device at home the first evening at least two times and then at least 2-3 times per day for the next five days during waking hours. It is noted in the trial outcome that the more often patients used the device, the better the effect and outcome they experienced with the Chemo Mouthpiece®.
As of November 2024, the clinical data has been submitted for peer review to one of the premiere Oncology journals for potential publication. The date of publication is TBD. Data from the clinical trial has been presented at several top Oncology meetings such as the 2024 Oncology Nursing Society (ONS) Congress and the 2024 Multinational Association for Supportive Care in Cancer (MASCC) Annual Meeting.
Patients should use the Chemo Mouthpiece® from their very first infusion. Patients begin using a frozen Chemo Mouthpiece® 10-15 minutes prior to the start of chemotherapy infusion. During infusion, after every 30 minutes of infusion, replace the Chemo Mouthpiece device with a fresh, frozen device from the cooler. Total devices and time of use will depend on the specific chemotherapy regimen and length of the infusion time.
In the clinical trial, most patients were able to adhere to using the devices for an extended period of time. Patients may take a 5-minute break from using the device, if needed, at the time of substitution of a fresh frozen device.
When chemotherapy agents are still circulating in the bloodstream, even at lower levels than at initial infusion, they can still cause damage to the oral mucosa. The best efficacy has been demonstrated when patients utilized a frozen Chemo Mouthpiece® device at least two to three or more times per day for the next five days.
This depends on the individual patient. The device is rigid and light enough to be gently held in place by a patient’s jaw muscles. Many patients will alter between holding the device with their hands or not. Tilting the head back eases the use of the device without your hand.
Patients may take a break for these important activities. It is recommended the patient resume use of the Chemo Mouthpiece® as soon as possible, because the best efficacy has been shown when keeping the oral cavity cold for as long as possible during and after infusion.