Effects of Dried Plum (Prune) Intake on the Incidence of Low Anterior Resection Syndrome in Patients With Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms; Low Anterior Resection Syndrome
Study type: Interventional

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. 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.
    


Intervention name(s): Prune (dried plum)
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment