What stage is the PANOVA trial?
The PANOVA trial for patients with pancreatic cancer is a Pilot trial that builds on experience from comprehensive preclinical experiments and clinical studies not directly done for the medical condition under investigation. Because the NovoTTF-100L(P) System is a device and not a drug, it does not follow the traditional Phase I, Phase II, Phase III process that an investigational new drug would follow. This Pivotal Trial is similar in structure and purpose to a drug Phase II trial.
How can I take part in the PANOVA trial?
Do patients pay to participate in the PANOVA trial?
No. The trial sponsor will provide the NovoTTF-100L(P) System and all supporting accessories free of charge. See [THE PANOVA TRIAL] for more information.
What are the expected side effects of TTFields?
The use of the NovoTTF-100L(P) System is not expected to have systemic side effects, based on our clinical data to date for various indications. Patients have experienced skin irritation beneath the transducer arrays. For more information, see [SCIENTIFIC AND CLINICAL EXPERIENCE].
When TTFields are delivered, the transducer arrays may cause mild warming and tingling of the skin underneath them.
Please consult with a study physician at one of the centers participating in the trial for additional information about potential side effects from using the NovoTTF-100L(P) and the other treatments in the PANOVA clinical trial.
Do I need to carry the device all the time?
The system and the portable battery weigh about 3 kilograms altogether and can be carried in a dedicated shoulder bag or backpack when walking around. Patients may not necessarily be physically carrying the system most of the time, but will rather use it while it is continuously placed in one location (e.g. on a desk, a table or on the floor inside the carrying bag). The system was designed to allow the performance of normal daily routines.
Will the use of TTFields pose any risk to family members or other people?
The use of the device will not interfere with household or standard personal electrical devices. There is no exposure of TTFields to non-users, such as co-workers and family members.
How will the device affect my social life?
The device was designed to allow patients to continue with daily routines. The transducer arrays will be concealed underneath your clothes. The Device Support Specialist (DSS) will offer help and support related to appearance issues if you are using TTFields. For additional information, please see Living with TTFields.
If I enroll in the PANOVA trial, will I receive TTFields for my illness?
Yes, all patients enrolled in the PANOVA trial will receive TTFields, alongside with the best standard chemotherapy currently used to treat this medical condition. The study is currently enrolling patients who are amenable to receive nab-paclitaxel (brand name: abraxane) for the treatment of their pancreatic cancer.
How long do I need to wear the device in the PANOVA trial?
Patients wear the device throughout the day and night. Patients may remove the device for short breaks to accommodate personal needs. Treatment on the trial continues until your study doctor diagnoses progression of the pancreatic tumor according to the protocol, or until a serious medical condition requires discontinuation of the treatment. In addition, you may decide to stop the TTFields at any point in time after starting the use of the device. For more information about the PANOVA trial, see [THE PANOVA TRIAL] or contact one of the participating centers.