Rectal CancerNCT05907642
Effects of Dried Plum (Prune) Intake on the Incidence of Low Anterior Resection Syndrome in Patients With Rectal Cancer
A study testing Prune (dried plum) in people with Rectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Colorectal cancer is the third leading cause of cancer death and the fourth most commonly diagnosed cancer in the world. The importance of improving the quality of life of patients after colorectal cancer surgery has been gradually emphasized as the survival period after treatment increases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Prune (dried plum)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-69
- tumor located at the rectum or rectosigmoid colon
- who underwent curative surgical resection, low anterior resection
Who cannot join
- neoadjuvant chemoradiotherapy
- formation of diverting stoma
- preoperative stent insertion
- food allergy
- chronic constipation
- Diabetes mellitus
- previous surgical history of bowel resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dried Plum (Prune) Intake on the Incidence of Low Anterior Resection Syndrome in Patients With Rectal Cancer: a Randomized Controlled Trial.
Colorectal cancer is the third leading cause of cancer death and the fourth most commonly diagnosed cancer in the world. The importance of improving the quality of life of patients after colorectal cancer surgery has been gradually emphasized as the survival period after treatment increases. Especially, patients who underwent rectal cancer surgery experience complex bowel movement abnormalities called 'lower anterior resection syndrome' such as urgency, tenesmus, frequent stool passing, which severely degrades the quality of life after surgery. To manage these symptoms, several treatment modalities including medication, neurostimulation, or biofeedback have been tried, but they are not fully effective. Therefore, we designed this clinical trial to examine the effects of dietary supplementation of the fruit, 'Prune', on improving bowel function after anterior resection rectal cancer surgery.
Prune is a dried fruit made from American plums with no seeds, and popular in the worldwide for its sweet and sour flavor and texture. In particular, the high content of sorbitol and dietary fiber softens the stool and improves the overall intestinal function, showing an excellent effect on alleviating constipation symptoms, which has been well studied in several clinical trials.
Read more
This study is going to be performed on patients under the age of 65 with primary rectal cancer and rectosigmoid colon cancer who underwent low anterior resection (LAR) exclusive of neoadjuvant chemoradiotherapy. Patients who are treated preoperatively with metallic stent insertion will be excluded. Those who have fruit allergy, diabetes, or chronic constipation will also be excluded. Subjects will be randomly assigned to treatment (Prune) or control group (No-prune) immediately after the surgery. Subjects who are assigned to the treatment group consume a total of 100 g of prune per day and the subjects assigned to the control group are allowed to have a normal meal without prune for 18 days. All subjects should fulfill the LAR syndrome questionnaire, The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-c30), and the defecation habit questionnaire on the day before the surgery and the postoperative day 21. And the subjects also fulfill the defecation diary till the postoperative day 21. The primary endpoint is the incidence of LAR syndrome. The secondary endpoint was the score of EORTC QLQ-C30, defecation habit questionnaire.
Prune intake is less costly than conventional medical treatments for improving bowel function, and it is expected to show high compliance for patients due to the ease of application. Furthermore, if this study demonstrates that prune intake improves the symptoms of LAR syndrome and quality of life after rectal cancer surgery, the ingredients and components of prune could be used to develop new drugs for alleviating the symptoms of LAR syndrome.
- Conditions
- Rectal Cancer
- Being tested
- Prune (dried plum)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prune (dried plum)Other
Subjects who are assigned to the treatment group consume a total of 100 g of prune per day for 18 days and the subjects who are assigned to the control group are allowed to have a normal meal without prune for 18 days.
| Study group | Role | What they receive |
|---|---|---|
| Prune | Experimental | During the first 3 days of taking the prunes, 60 g (6 pieces of prune) were consumed per day, and if there were no symptoms corresponding to the safety endpoints for 3 days, the amount was increased to 100 g per day thereafter. Prunes were consumed twice, half each in the morning and afternoon, and the total intake period was 18 days. Receives: Other: Prune (dried plum) |
| No-prune | Placebo comparator | No intervention was provided to the control group, and all normal diets were allowed except for prunes during the study period, for 18 days. Receives: Other: Prune (dried plum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Anterior Resection Syndrome Questionnaire Score
Measured: Postoperative day 21
Secondary outcomes (1)
The European Organization for Research and Treatment of Cancer quality of life questionnaire c-30
Measured: Postoperative day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Aug 2019
- Primary completion1 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907642
- Sponsor's protocol ID
- Ottugi-Prune
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 18 Jun 2023
- 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dried Plum (Prune) Intake on the Incidence of Low Anterior Resection Syndrome in Patients With Rectal Cancer: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05907642
- Acronym / sponsor ID
- Ottugi-Prune
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 18 Jun 2023 (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.
Colorectal cancer is the third leading cause of cancer death and the fourth most commonly diagnosed cancer in the world. The importance of improving the quality of life of patients after colorectal cancer surgery has been gradually emphasized as the survival period after treatment increases. Especially, patients who underwent rectal cancer surgery experience complex bowel movement abnormalities called 'lower anterior resection syndrome' such as urgency, tenesmus, frequent stool passing, which severely degrades the quality of life after surgery. To manage these symptoms, several treatment modalities including medication, neurostimulation, or biofeedback have been tried, but they are not fully effective. Therefore, we designed this clinical trial to examine the effects of dietary supplementation of the fruit, 'Prune', on improving bowel function after anterior resection rectal cancer surgery.
Prune is a dried fruit made from American plums with no seeds, and popular in the worldwide for its sweet and sour flavor and texture. In particular, the high content of sorbitol and dietary fiber softens the stool and improves the overall intestinal function, showing an excellent effect on alleviating constipation symptoms, which has been well studied in several clinical trials.
This study is going to be performed on patients under the age of 65 with primary rectal cancer and rectosigmoid colon cancer who underwent low anterior resection (LAR) exclusive of neoadjuvant chemoradiotherapy. Patients who are treated preoperatively with metallic stent insertion will be excluded. Those who have fruit allergy, diabetes, or chronic constipation will also be excluded. Subjects will be randomly assigned to treatment (Prune) or control group (No-prune) immediately after the surgery. Subjects who are assigned to the treatment group consume a total of 100 g of prune per day and the subjects assigned to the control group are allowed to have a normal meal without prune for 18 days. All subjects should fulfill the LAR syndrome questionnaire, The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-c30), and the defecation habit questionnaire on the day before the surgery and the postoperative day 21. And the subjects also fulfill the defecation diary till the postoperative day 21. The primary endpoint is the incidence of LAR syndrome. The secondary endpoint was the score of EORTC QLQ-C30, defecation habit questionnaire.
Prune intake is less costly than conventional medical treatments for improving bowel function, and it is expected to show high compliance for patients due to the ease of application. Furthermore, if this study demonstrates that prune intake improves the symptoms of LAR syndrome and quality of life after rectal cancer surgery, the ingredients and components of prune could be used to develop new drugs for alleviating the symptoms of LAR syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prune | Experimental | Other: Prune (dried plum)During the first 3 days of taking the prunes, 60 g (6 pieces of prune) were consumed per day, and if there were no symptoms corresponding to the safety endpoints for 3 days, the amount was increased to 100 g per day thereafter. Prunes were consumed twice, half each in the morning and afternoon, and the total intake period was 18 days. |
| No-prune | Placebo comparator | Other: Prune (dried plum)No intervention was provided to the control group, and all normal diets were allowed except for prunes during the study period, for 18 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-69
- tumor located at the rectum or rectosigmoid colon
- who underwent curative surgical resection, low anterior resection
Key exclusion criteria (7 listed)
- neoadjuvant chemoradiotherapy
- formation of diverting stoma
- preoperative stent insertion
- food allergy
- chronic constipation
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 |
|---|---|---|
| Prune (dried plum)Subjects who are assigned to the treatment group consume a total of 100 g of prune per day for 18 days and the subjects who are assigned to the control group are allowed to have a normal meal without prune for 18 days. | Other | No-prune, Prune |
Primary outcome
Low Anterior Resection Syndrome Questionnaire Score
Time frame: Postoperative day 21
1 secondary outcome
The European Organization for Research and Treatment of Cancer quality of life questionnaire c-30
Time frame: Postoperative day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prune (dried plum) in people with Rectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 18 Jun 2023. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Anterior Resection Syndrome Questionnaire Score (time frame: Postoperative day 21). 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 18 Jun 2023.