Short-course, low-dose Cytoxan is commonly used by doctors to treat autoimmune diseases and has emerged as the current standard of care for the treatment of scleroderma. A variety of medical reports suggest that high-dose Cytoxan is beneficial in patients with severe scleroderma and particularly effective in slowing down damage in the lungs.
The dose being used in this study is about 50% higher than that commonly used to treat scleroderma. While lower doses may be helpful, SCOT investigators believe that a higher dose over a longer time may be more effective. However, this dose is considered investigational because it has never been studied in a clinical research study. Here is an overview of the steps involved in monthly high-dose Cytoxan group.
Before Each Cytoxan Infusion
To maximize your safety during the 12 months of Cytoxan, you will have a physical exam and several laboratory tests prior to each infusion. A urine specimen will be needed, and approximately 1 tablespoon of your blood will be taken.
To prepare your body for the Cytoxan, you will be asked to drink at least 8 cups of fluid per day for 2 days before your infusion.
Each Cytoxan infusion will be given through your vein over about 1 hour. Medications will be given to decrease any possible side effects such as nausea and vomiting.
After Each Cytoxan Infusion
Unless you are instructed differently by your doctor, you will need to drink at least 8 cups of fluid each day for 2 days. This will help your body flush out the Cytoxan to avoid prolonged bladder contact with the drug. You will need to urinate frequently for 2 days after each infusion, including once during the night. You will be given medications to decrease nausea and vomiting if they occur. Ten to 14 days after each infusion, you will be asked to provide a urine specimen and approximately 1 tablespoon of your blood will be taken. Your doctor will check these samples to be sure your blood count levels and kidney function are stable.
Risks and Side Effects
Serious side effects have been associated with the study procedures in the SCOT study. Possible risks and side effects are listed on this web site; however, all interested participants should carefully review the SCOT research consent form for further detail.