Phase 1 trial tests probiotic treatment for radiation side effects in the gut

Cancer Center pilot grant funds early-career investigator

University of Cincinnati Cancer Center researchers are looking to the gut microbiome as a potential pathway to reduce certain side effects of radiation therapy.

Bailey Nelson, MD, Radiation Oncology

Bailey Nelson, MD. Photo/University of Cincinnati.

Bailey Nelson, MD, has been awarded a $50,000 pilot grant from the Cancer Center to open a Phase 1 trial testing if a probiotic supplement can reduce gastrointestinal (GI) symptoms for patients undergoing whole pelvis radiotherapy.

Pelvic radiation therapy, a common treatment for GI, genitourinary (GU) and gynecologic cancers, uses high-energy rays to destroy cancer cells in the pelvic area — but it can lead to acute and chronic side effects that include diarrhea, fecal urgency, abdominal cramping and malabsorption.

“The exact mechanism of gastrointestinal symptoms is elusive, but there is sufficient data to suggest that the intestinal microbiome plays a role in radiation-induced GI injury,” said Nelson, associate member of the Cancer Center and assistant professor in the Department of Radiation Oncology in UC’s College of Medicine. “The microbiome likely plays a much larger role in cancer development and treatment toxicity than we ever imagined.”

The intestinal microbiome is populated by trillions of microorganisms such as bacteria, viruses, fungi and parasites. This includes “bad” bacteria that can cause illness and “good” bacteria like Akkermansia muciniphila, which helps break down mucus in the intestines to maintain the intestinal lining.

Previous studies and preclinical models have shown A. muciniphila was protective of radiation-induced GI toxicity by enhancing intestinal repair, Nelson said. “In our previous institutional retrospective study, A. muciniphila was enriched in patients with no-to-mild diarrhea after whole pelvic radiotherapy compared to patients with moderate-to-severe diarrhea, indicating that it may be protective against radiation-induced GI toxicity.”

If we can find ways to manipulate and harness the microbiome to lessen treatment-related toxicity and decrease rates of cancer development and progression, it could be truly revolutionary

Bailey Nelson, MD

Patients with GI, GU and gynecologic cancers undergoing whole pelvis radiotherapy enrolled in the trial will receive a 10-week course of a 5-strain probiotic supplement that includes A. muciniphilia. Approximately 20 patients are planned to be enrolled.

The primary objective is to evaluate adherence and tolerability of the probiotic, and Nelson and her team will additionally assess GI toxicity outcomes, particularly diarrhea. If probiotic supplementation is well tolerated in patients, the team plans to design a larger randomized controlled trial to more rigorously evaluate its potential protective effects.

“If we can find ways to manipulate and harness the microbiome to lessen treatment-related toxicity and decrease rates of cancer development and progression, it could be truly revolutionary,” Nelson said. “This is only the beginning.”

The Cancer Center’s Pilot Project Award Program, designed to empower early-stage investigators, provides both funding and mentorship to help researchers develop their ideas into full-scale clinical studies. For Nelson, the award offered a unique opportunity to gain hands-on experience while designing and launching a clinical trial under the mentorship of Jordan Kharofa, MD.

“Through this program, under the guidance of my mentor, I am learning how to write grants, design Phase 1 clinical trials, create research budgets, collaborate with various colleagues and consultants, and more,” she said. “I am extremely grateful for this educational opportunity and the support of the Cancer Center.”

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For more information on the trial, please call 513-585-8222.

Featured photo at top of probiotic bacteria. Photo/Anusorn Nakdee/iStock Photo.

 

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