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13.3 appendix c patient instructions

You are participating in a study of Everolimus and its effectiveness in the treatment of kidney cancer. It is important that you take your medication as instructed. If you are unable to take the medication as instructed, you should contact the Study Team as soon as possible. Please keep in mind the following:  
- You should take your medication once/ day, at approximately the same time every day. You should take the medication with a full glass of water. You may take the medication with or without food, whichever you choose, but should take it that way consistently. Record the date and time you have taken the medication on your diary.
If you should vomit your medication after taking it, do not take the medication again.  
- Record any side effects you experience on your diary. Bring your Pill and Side Effect diaries, your remaining medication, and empty pill vials with you to each appointment.  
- You cannot eat grapefruit, Seville oranges, or star fruit, or drink their juices while on this study.  
- Your medication may decrease the effectiveness of your immune system. Wash your hands frequently, and avoid others with cold symptoms. If you develop a cough, fever, painful urination, sore throat, runny nose, or any symptom that does not feel right, call your study team. DO NOT RECEIVE VACCINES while on study until you check with your study team first! You cannot have close contact with individuals who have received live vaccines such a measles, mumps, rubella, varicella, typhoid, oral polio, BCG, or yellow fever for 4 weeks post vaccination.  
- Your medication may also affect your lungs. If you develop shortness of breath, at rest or on exertion, chest pain, or cough, call your study team as soon as possible.  
- A common side effect of your medication is sores in your mouth. Perform frequent oral hygiene, but avoid mouthwashes with alcohol. If you develop a mouth sore, rinse frequently with warm saline mouth rinses, or the mouth rinses provided by your study team. Eat soft, bland food. If you are having difficulty eating or drinking, call your study team immediately.  
- Avoid sun exposure, and always wear sunscreen when outdoors (> SPF 30).
- Do not drink alcohol (including beer and wine) unless approved by the study team.  
- If you should need dental work or surgery, notify your team immediately.  
- You will be given medication at the beginning of the trial to be used only as needed. If you need any of these medications, follow the directions on the label, and record that you have taken the medication in your diary. If the symptoms persist even after taking the medication, call your study team. These medications are: 1.Ondansetron (Nausea); 2.Loperimide (Diarrhea); 3.Colace (Constipation); 4. Lidobenalox Oral Solution (Mouth Sores).
Please call your study team with ANY questions or change in your condition.  
Martha Ninos RN (Study Coordinator) 240-760-6248 (Mon-Fri: 8-4PM) ***
Julia Friend PA-C 301-240-271-8121 (Mon-Fri: 8-4PM) ***
*** Evenings, weekends, and emergencies call Hospital paging @ 301-496-1211 and ask to speak to the Urology Fellow On Call