This research is to determine if an oral probiotic, Pendulum Glucose Control (PGC), can be safely given to patients during pelvic radiation therapy (RT). The researchers will study if the probiotics lessen gastrointestinal toxicity during pelvic radiation.
The exact mechanism of GI symptoms is elusive, but there is sufficient data to suggest that the intestinal microbiome plays a role in radiation-induced GI injury. The investigators propose a pilot feasibility trial evaluating whether an oral 5 strain probiotic (PGC) can be safely and effectively administered during pelvic RT. PGC will be supplied by Pendulum Therapeutics. Pendulum has completed trials using PGC in non-cancer conditions \[26\]. The investigators hypothesize that oral supplementation with PGC for GI toxicity mitigation during pelvic radiation is feasible. The intervention will be considered feasible if probiotic tolerability and patient adherence are appropriate. An overall probiotic adherence rate of ≥ 80% by ≥ 70% of patients will be considered acceptable. If feasible, these results will support evaluation of toxicity mitigation in randomized subsequent Phase II/III trials of PGC supplementation during pelvic radiation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Pendulum Glucose Control (PGC) WBF-038 - 2 capsules Orally with food. Once daily for 10 weeks
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
RECRUITINGPendulum Glucose Control (PGC) Probiotic Adherence Rate (PAR)- measured by pill counts
1\. To evaluate Pendulum Glucose Control (PGC) Probiotic Adherence Rate (PAR). a. To assess Probiotic Adherence Rate (PAR), pill counts will be conducted at week 6 and week 10.
Time frame: Week 6 and week 10
Physician-reported GI toxicity with the addition of PGC - measured by CTCAE v6
To assess physician-reported GI toxicity, AEs using CTCAE v6 will be collected at baseline, week 4, week 6 and week 10. This will also be assessed at the 30 day safety visit after patients discontinue the supplement.
Time frame: Baseline, week 4, week 6 and week 10. Week 14 (safety visit)
Patient-reported GI toxicity with the addition of PGC measured by PRO-CTCAE
To assess patient-reported GI toxicity, an EPIC Bowel and a customized PRO-CTCAE will be collected at baseline, week 4, week 6 and week 10. This will also be assessed at the 30 day safety visit after patients discontinue the supplement.
Time frame: Baseline, week 4, week 6 and week 10. Week 14 (safety visit)
Bailey Nelson, MD
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