Chewing Gum for Colon Cancer Screening
What You Need to Know Before You Apply
What is the purpose of this trial?
Colorectal cancer is the second leading cause of cancer deaths that could be prevented in the United States. Colonoscopy is the best test for finding and removing polyps before they turn into cancer. However, many people are hesitant to have a colonoscopy because of the bowel preparation. The preparation can be difficult to tolerate, with patients often struggling to finish it due to the taste, volume, or side effects like nausea and bloating. This can lead to incomplete procedures or discourage people from getting screened at all.
Chewing sugar-free gum is a simple, low-cost, and safe intervention that may make the preparation process easier. One study from China found that chewing gum did not change the quality of bowel cleansing, but patients reported that they were more satisfied with the process. No U.S.-based studies have tested this strategy, and no prior research has looked at whether gum chewing has different effects in people using high-volume versus low-volume prep solutions.
The investigators will randomize 160 participants to the stated intervention or control using computer-generated 1:1 randomization. Upon completing the study, the investigators will analyze the data.
By studying gum chewing during bowel preparation, the investigators hope to find out whether this small change can make bowel prep more tolerable and encourage more patients to complete their colonoscopy. If successful, this approach could help more people get screened, leading to earlier detection and prevention of colorectal cancer in the community.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Bowel Preparation
Participants undergo split-dose bowel preparation with or without chewing gum
Colonoscopy Procedure
Participants undergo colonoscopy to assess bowel cleansing quality and other metrics
Follow-up
Participants are monitored for adverse events and outcomes post-procedure
What Are the Treatments Tested in This Trial?
Interventions
- Chewing Sugar-Free Gum
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Participants randomized to the experimental arm will chew one piece of sugar-free gum for approximately 15-20 minutes, 30 minutes before starting the first dose of split-dose bowel preparation and again 30 minutes after the second dose. The gum is sugar-free and non-medicated. Participants will be instructed not to swallow the gum and to discontinue chewing if they experience discomfort. All participants will receive standard bowel preparation (either 4L PEG or 2L PEG + ascorbate, prescribed according to clinical indication). The endoscopist performing the colonoscopy will remain blinded to group assignment.
Arm Description: Participants randomized to the experimental arm will chew one piece of sugar-free gum for approximately 15-20 minutes, 30 minutes before starting the first dose of split-dose bowel preparation and again 30 minutes after the second dose. The gum is sugar-free and non-medicated. Participants will be instructed not to swallow the gum and to discontinue chewing if they experience discomfort. All participants will receive standard bowel preparation (either 4L PEG or 2L PEG + ascorbate, prescribed according to clinical indication). The endoscopist performing the colonoscopy will remain blinded to group assignment.
Participants in the control arm will undergo standard split-dose bowel preparation (4L PEG) according to clinical indication, without chewing gum before or after the preparation. Endoscopists will be blinded to participant group assignment.
Arm Description: Participants in the control arm will undergo standard split-dose bowel preparation (2L PEG + ascorbate) according to clinical indication, without chewing gum before or after the preparation. Endoscopists will be blinded to participant group assignment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
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