Bluestone Trials

Cancer Pain Study

Are you experiencing chronic cancer pain even on your current opiate medications?
Status: Completed.

Battling cancer is its own challenge. But when you’re also fighting the chronic or continuing pain associated with cancer, this challenge can be overwhelming. Doctors typically prescribe medications—such as morphine or oxycodone—for chronic cancer pain relief; however, even with increased medication dosage, some patients still experience chronic pain. In addition, these medications often include unwanted side effects that prevent patients from taking the higher doses needed to help relieve their chronic pain. Researchers are now conducting a clinical research study evaluating the effectiveness of an investigational medication for the treatment of chronic cancer pain when it is taken in addition to your current pain medications.

SPRAY III (Sativex® for Pain Research in Advanced malignancY) is a clinical research study to determine if the investigational medication Sativex® (nabiximols) is effective in managing chronic cancer pain. An investigational medication is one that has not been approved yet by your country. Sativex® has been approved in Canada as an add-on treatment for pain in patients with advanced cancer.

Sativex® comes in the form of a mouth spray taken by spraying it in your mouth on the inside of your cheeks. More details on how to take this study medication will be provided to you if you decide to participate in the SPRAY III study.

What would I have to do if I decide to participate in the SPRAY III study?

If the study staff determines you are eligible for the SPRAY III study and you decide to participate, your participation could last approximately 9 weeks. During this time you will make four visits to the study clinic and one follow-up phone call. Each clinic visit will last about 2 hours. 

During the clinic visits, you will undergo a series of medical tests and evaluations to monitor your safety and progress. These tests and evaluations will include physical exams (including exams of your mouth); vital sign measurements (blood pressure, heart rate, height, and weight); the collection of blood and urine samples forlaboratory testing; and electrocardiograms (EKGs) or heart tracings, which measure the activity of your heart.The study doctor will also ask you questions about your medical condition, pain, medication use, and medical history. If you are a woman and your blood samples show that you are pregnant, you will not be allowed to participate in the SPRAY III study. 

In addition, you will need to call an automated telephone number every day to record your level of pain, your sleep disruption (if any), and your study medication usage. After completion of the 9-week study, you may have the option to enter an extension study, which provides continued availability of Sativex®. 

More information is available at Spray3Study.com