Experimental Regenerative Medicine Therapy Could Benefit Patients with Cancer Treatment-Related Dry Mouth

Radiation treatments for head and neck cancer, while serving a curative purpose, can often wreak havoc on a patient’s salivary glands, making it difficult to do everyday things like talk, eat and sleep after treatment is done.

A new regenerative therapy that the Food and Drug Administration (FDA) recently gave the OK to test in clinical trials could offer a lifeline to those who suffer from the effects of xerostomia, also known as dry mouth, as a result of radiation therapy. In an interview with CURE®, Dr. Randy Kimple, the trial’s lead investigator at the UW Carbone Cancer Center, spoke with us about how dry mouth impacts patients and what the goals of this trial are.

Transcription

Dry mouth caused by radiation, or xerostomia, is a significant lifelong side effect for many of our head and neck cancer patients. Xerostomia affects dental health, it affects speech and swallowing; it affects sleep, the ability to work and communicate; and it affects just the overall wellbeing of patients.

And essentially, the only effective treatments we have today are to avoid radiation to the glands, which is a great goal, but frankly, is not possible in many of our patients. Because the head and neck is a pretty small area, and the cancers that we treat tend to be located in close proximity to the salivary glands.

Then, the best thing that I often tell my patients is carry a water bottle with you. Eat food that is moist, as opposed to breads or dried foods, or certain types of meat that really require a lot of saliva to chew and swallow. And those aren't great options for patients. That’s really, from a 21st century medicine standpoint, that's pretty basic.

And so, our hope is that we can use this approach, taking a patient's bone marrow, isolating these stromal cells, growing them up in the lab, and then injecting them into the salivary glands to sort of reinvigorate the gland.

The approval that we got from the FDA over the past month, is essentially to do that in a controlled environment, in a clinical trial that's really focused on (determining if) this a safe approach to take. Mesenchymal stromal therapy or cell therapy like this has been used in a number of different diseases, but our particular approach to it has not been used in humans yet. So, I want to be really cautious about saying we want to make sure it's safe first, and after we know, it's safe, then we want to see if it's effective.

And so, the approach that we're taking is a very common approach in cancer research, where, you know, the first study is a safety study, initially going one patient at a time, doing the treatment, following them for a month, making sure it's safe, then taking the next patient, and so on for the first five patients.

And then if we get a good sense that it is safe, that there's not a lot of side effects, starting to expand what we do, increasing the amount of the cells that we give to patients, and ultimately starting to take a look at if this works. I wish that I could say that we're a year away from having a great treatment that works for a lot of patients. But the fact is that we're probably five years away from that. And that's just the pace of medical research.