The Lack of Tobacco Assessment in Cancer Clinical Trials

Tobacco products can have an effect on cancer and cancer treatment, therefore hindering progress, so why are we not incorporating tobacco assessments into our cancer clinical trials?

According to a group of investigators at Roswell Park Cancer Institute (RPCI), few cancer researchers assess clinical trial participants for tobacco use. Dr. Graham Warren, MD, PhD, assistant professor in the department of radiation medicine at RPCI, recently led a team of researchers to conduct a survey to evaluate 155 actively recruiting cooperative-group clinical trials funded by the National Cancer Institute.

The survey showed that less than 30 percent of active trials assess any form of tobacco use at the time of enrollment. In addition, less than 5 percent assess tobacco use during follow-up, and none provide cessation support.

Warren states that tobacco use during cancer treatment reduces the effectiveness of treatments, increases the toxicity of those treatments, and ultimately causes more people to die from their cancer.

The lack of tobacco assessment may affect the ability to accurately assess how well a particular treatment is working, or even have an effect on clinical trial outcome and patient survival.

Tobacco use not only contributes to the effectiveness of cancer treatment, it can also have an effect on the cardiovascular and pulmonary system as well -- many investigational drugs can be cardiotoxic.

Patients enrolled in cancer clinical trials who are active smokers may not receive the support they need regarding tobacco cessation. Although many patients are assessed for tobacco use when initially seen by an oncologist, tobacco use follow-up may not occur and more than likely won't occur at the point of clinical trial enrollment.

As a former cancer clinical trials coordinator, I have to say that I rarely remember any of the cancer clinical trials assessing tobacco use. Clinical trial inclusion and exclusion criteria are generally the focus prior to patient enrollment. If tobacco use is not mentioned in the patient's history, then it probably will not be addressed.

Do you offer tobacco cessation support and education for all of your cancer patients who use tobacco products?

To view this article in full, please visit Roswell Park Cancer Institute.