Colorectal Cancer (CRC)Phase 1/2NCT06860685
Trial of Gum Chewing to Enhance the Restoration of Intestinal Motility in Colorectal Cancer Surgery
A Phase 1/2 study testing gum chewing in people with Colorectal Cancer (CRC), run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
Surgery is one of the most frequent treatments of colorectal cancer. However, delayed restoration of intestinal motility is a common phenomenon in patients who undergo colorectal surgery, and may reduce comfort, prevent the early hospital discharge of patients and increase healthcare costs. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- gum chewing
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Aug 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed colorectal cancer
- Undergo open or laparoscopic colorectal surgery
- Able to give informed consent
- With normal verbal skills
Who cannot join
- Preoperative lower extremity dysfunction
- Dysphagia before surgery
- Patients who are discharged ,transferred to another hospital or die within 72
- hours after surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Afffliated Cancer Hospital of University of Electronic Science and Technology of China
Chengdu, Sichuan, 610041
Hui Yang, M.M., 8618908191080, yanghui1@scszlyy.org.cn
About this study
Official title: A Non-randomised External Controlled Trial of Gum Chewing to Enhance the Restoration of Intestinal Motility in Colorectal Surgery
Surgery is one of the most frequent treatments of colorectal cancer. However, delayed restoration of intestinal motility is a common phenomenon in patients who undergo colorectal surgery, and may reduce comfort, prevent the early hospital discharge of patients and increase healthcare costs. Gum chewing is a kind of safe and easily accessible sham feeding to stimulate intestinal motility. In addition, prediction models were used to estimate the risk of delayed restoration of intestinal motility after colorectal surgery. Thus, this study is an External Controlled trial that will determine whether stratified application of gum chewing by risk prediction model will enhance restoration of intestinal motility and reduce healthcare costs in paitents undergoing open or laparoscopic colorectal surgery.
Read the detailed description
Background:
Identifying patients at high risk of delayed restoration of intestinal motility at an early stage and adopting individualized interventions is crucial. The risk prediction model can provide a highly accurate, individualized evidence-based risk estimation by identifying risk factors and creating a risk stratification system. In addition, gum chewing is a kind of sham feeding that has been reported to stimulate intestinal motility and emerged as a popular, simple, safe, effective method for enhancing restoration intestinal motility. Thus, this study combines risk prediction model and gum chewing, aiming to use pre- and intraoperative risk factors to predict the risk of delayed restoration of intestinal motility. After creating a risk stratification system, patients with colorectal surgery will be stratified to high-risk group or low-risk group of delayed restoration of intestinal motility.
Objective:
To compare the efficacy and economics of gum chewing in patients undergoing open or laparoscopic colorectal surgery after stratification by a risk prediction model.
Design:
This is a single-center, two-arm, prospective study and non-randomized external controlled trial.
Subjects:
Two hundred and ninety-two consecutive patients undergoing open or laparoscopic colorectal surgery will be recruited in experiment group, which includes high-risk group and low-risk group.
Interventions:
The low-risk group will only receive enhanced recovery care and the high-risk group will be instructed to chew gum as well as receive enhanced recovery care. The enhanced recovery care consists of no administration of intestinal antibiotics and normal diet until 6 hours before surgery; no nasogastric drainage and minimal perioperative introvenous fluid on the day of surgery; patients start to ambulate and drink water on the first postoperative day. Patients in high-risk group are instructed to chew the piece of sugar-free gum three times (at least 10 minutes) a day from the first postoperative morning until oral dietary intake.
Outcome measures:
The outcomes are first flatus time、first defecation time、Proportion of delayed restoration of intestinal motility、length of hospital stay. All the patients will be assisted to fill in "Patient Log" about the first flatus time and first defecation time after surgery until the oral dietary intake.
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- gum chewing
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gum chewingDietary supplement
Participants allocated to chewing gum will be instructed to chew commercially available sugar-free gum (Extra \& Reg, Wm. Wrigley Jr. Co., Ltd., Shanghai, China) three times daily from the first postoperative morning until oral dietary intake. They were instructed to chew the piece of gum for at least 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| gum chewing in high-risk group | Experimental | Patients will receive enhanced recovery care and gum chewing (three times per day) on the first postoperative morning until oral dietary intake. Receives: Dietary Supplement: gum chewing |
| Control in low-risk group | No intervention | Patients only receive Enhanced recovery care, including no administration of intestinal antibiotics; normal diet until 6 hours before surgery; no nasogastric drainage; minimal perioprative intravenous fluid; patient started to ambulate and drink water on the first postoperative day |
What is being measured
The primary outcome is the main question the study is designed to answer.
first flatus time
time to the passage of first flatus
Measured: end of surgery to first passage of flatus, up to 3 days
first defecation time
time to the first defecation
Measured: end of surgery to first passage of defecation, up to 3 days
proportion of delayed restoration of intestinal motility
The proportion of delayed restoration of intestinal motility will be caculated as the number of participants with delayed restoration of intestinal motility divided by the total number of participants enrolled in the study
Measured: up to 3 days
length of hospital stay
Measured: up to 30 days (till successful discharge from secondary care to home, up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Yang, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860685
- Sponsor's protocol ID
- SCCHEC-02-2020-059
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomised External Controlled Trial of Gum Chewing to Enhance the Restoration of Intestinal Motility in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT06860685
- Acronym / sponsor ID
- SCCHEC-02-2020-059
- Conditions
- Colorectal Cancer (CRC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgery is one of the most frequent treatments of colorectal cancer. However, delayed restoration of intestinal motility is a common phenomenon in patients who undergo colorectal surgery, and may reduce comfort, prevent the early hospital discharge of patients and increase healthcare costs. Gum chewing is a kind of safe and easily accessible sham feeding to stimulate intestinal motility. In addition, prediction models were used to estimate the risk of delayed restoration of intestinal motility after colorectal surgery. Thus, this study is an External Controlled trial that will determine whether stratified application of gum chewing by risk prediction model will enhance restoration of intestinal motility and reduce healthcare costs in paitents undergoing open or laparoscopic colorectal surgery.
Detailed description
Background:
Identifying patients at high risk of delayed restoration of intestinal motility at an early stage and adopting individualized interventions is crucial. The risk prediction model can provide a highly accurate, individualized evidence-based risk estimation by identifying risk factors and creating a risk stratification system. In addition, gum chewing is a kind of sham feeding that has been reported to stimulate intestinal motility and emerged as a popular, simple, safe, effective method for enhancing restoration intestinal motility. Thus, this study combines risk prediction model and gum chewing, aiming to use pre- and intraoperative risk factors to predict the risk of delayed restoration of intestinal motility. After creating a risk stratification system, patients with colorectal surgery will be stratified to high-risk group or low-risk group of delayed restoration of intestinal motility.
Objective:
To compare the efficacy and economics of gum chewing in patients undergoing open or laparoscopic colorectal surgery after stratification by a risk prediction model.
Design:
This is a single-center, two-arm, prospective study and non-randomized external controlled trial.
Subjects:
Two hundred and ninety-two consecutive patients undergoing open or laparoscopic colorectal surgery will be recruited in experiment group, which includes high-risk group and low-risk group.
Interventions:
The low-risk group will only receive enhanced recovery care and the high-risk group will be instructed to chew gum as well as receive enhanced recovery care. The enhanced recovery care consists of no administration of intestinal antibiotics and normal diet until 6 hours before surgery; no nasogastric drainage and minimal perioperative introvenous fluid on the day of surgery; patients start to ambulate and drink water on the first postoperative day. Patients in high-risk group are instructed to chew the piece of sugar-free gum three times (at least 10 minutes) a day from the first postoperative morning until oral dietary intake.
Outcome measures:
The outcomes are first flatus time、first defecation time、Proportion of delayed restoration of intestinal motility、length of hospital stay. All the patients will be assisted to fill in "Patient Log" about the first flatus time and first defecation time after surgery until the oral dietary intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gum chewing in high-risk group | Experimental | Dietary Supplement: gum chewingPatients will receive enhanced recovery care and gum chewing (three times per day) on the first postoperative morning until oral dietary intake. |
| Control in low-risk group | No intervention | –Patients only receive Enhanced recovery care, including no administration of intestinal antibiotics; normal diet until 6 hours before surgery; no nasogastric drainage; minimal perioprative intravenous fluid; patient started to ambulate and drink water on the first postoperative day |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with newly diagnosed colorectal cancer
- Undergo open or laparoscopic colorectal surgery
- Able to give informed consent
- With normal verbal skills
Key exclusion criteria (4 listed)
- Preoperative lower extremity dysfunction
- Dysphagia before surgery
- Patients who are discharged ,transferred to another hospital or die within 72
- hours after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gum chewingParticipants allocated to chewing gum will be instructed to chew commercially available sugar-free gum (Extra \& Reg, Wm. Wrigley Jr. Co., Ltd., Shanghai, China) three times daily from the first postoperative morning until oral dietary intake. They were instructed to chew the piece of gum for at least 10 minutes. | Dietary supplement | gum chewing in high-risk group |
Primary outcome
first flatus time
Time frame: end of surgery to first passage of flatus, up to 3 days
time to the passage of first flatus
first defecation time
Time frame: end of surgery to first passage of defecation, up to 3 days
time to the first defecation
proportion of delayed restoration of intestinal motility
Time frame: up to 3 days
The proportion of delayed restoration of intestinal motility will be caculated as the number of participants with delayed restoration of intestinal motility divided by the total number of participants enrolled in the study
length of hospital stay
Time frame: up to 30 days (till successful discharge from secondary care to home, up to 30 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing gum chewing in people with Colorectal Cancer (CRC), run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Yang, M.M. (8618908191080, yanghui1@scszlyy.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first flatus time (time frame: end of surgery to first passage of flatus, up to 3 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.