UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000008348 |
| Receipt No. | R000009820 |
| Scientific Title | Clinical effectiveness of daikenchuto (TJ-100) on gastrointestinal symptom after colectomy in colorectal cancer patients with abdominal pain and distention due to a bowel movement disorder. |
| Date of disclosure of the study information | 2012/07/04 |
| Last modified on | 2020/07/10 (Ver. 9) |
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| Basic information | ||
| Public title | Clinical effectiveness of daikenchuto (TJ-100) on gastrointestinal symptom after colectomy in colorectal cancer patients with abdominal pain and distention due to a bowel movement disorder. | |
| Acronym | Clinical effectiveness of daikenchuto (TJ-100) on abdominal pain and distention after cancer resection in the colorectal cancer patients. | |
| Scientific Title | Clinical effectiveness of daikenchuto (TJ-100) on gastrointestinal symptom after colectomy in colorectal cancer patients with abdominal pain and distention due to a bowel movement disorder. | |
| Scientific Title:Acronym | Clinical effectiveness of daikenchuto (TJ-100) on abdominal pain and distention after cancer resection in the colorectal cancer patients. | |
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| Condition | ||
| Condition | Colorectal cancer patients with abdominal pain and distention due to a bowel movement disorder. | |
| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | The purpose in this study is to examine a clinical effectiveness of daikenchuto on the gastrointstinal dysfunction-related symptom, such as abdominal pain and distention, and QOL after colectomy in the colorectal cancer patients with abdominal pain and distention due to a bowel movement disorder (prolonged POI high risk patients). |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | Pragmatic |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | 1) Gastrointestinal symptom. (abdominal pain /distention/ the sensation of incomplete bowel evacuation)2) number of postoperative day to comfirm first evacuation, number of postoperative time to comfirm first flatus, number of bowel movements per day. |
| Key secondary outcomes | 1) Pass Variance 2) QOL assessment using the GSRS questionnaire.3) number of white blood-cell and Neutrophilic, and CRP levels. 4) Abdominal radiography.5) Ileus and POI onset or not (a definition of ileus: The thing which the neighboring organizations adhere to intestinal tracts or an intestinal tract, and has higher than two items among intestinal tract stricture or an ileus state and abdomen symptoms. (abdominal pain,distention, nausea, vomiting) that it is, and may be related to a symptom of ileus).6) A dose / a rate of laxative |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| Randomization | Randomized |
| Randomization unit | Individual |
| Blinding | Open -no one is blinded |
| Control | Active |
| Stratification | NO |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | YES |
| Concealment | Central registration |
| Intervention | ||
| No. of arms | 2 | |
| Purpose of intervention | Treatment | |
| Type of intervention |
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| Interventions/Control_1 | Oral administration of test drug (daikenchuto) 5.0 g per dose as a general rule (15 g/day, t.i.d., before meals) from patiant consent day to preoperative day and postoperative day 2 to postoperative day 28. | |
| Interventions/Control_2 | Standard of care. | |
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| Interventions/Control_5 | ||
| Interventions/Control_6 | ||
| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | In order to participate in this study, a patient must meet all of the following criteria.1) Patient who was judged that an colectomy was possible for treatment of the colon or rectal cancer.Preoperative staging of disease:I, II, IIIa, IIIbTNM category distribution: T=1-3, N=0-2, M=02) Patients with PS (ECOG Performance Status Scale):0, 13) Patients who are diagnosed as pre-operative constipation CTCAE ver.4 grade is at least 1 and abdominal pain and/or distention GSRS score at least 3.4) Age: 20 years or older5) Gender: no specification6) Inpatient/Outpatient: Inpatient7) Patients who can provide written informed consent | |||
| Key exclusion criteria | In order to participate in this study, a patient must not meet any of the following criteria.1) Patients with history or at present of chemotherapy and/or radiotherapy for primary disease.2) Patients with lower colectory.3) Patients with concomitant inflammatory bowel disease such as ulcerative colitis and crohn disease.4) Patients with cancerous peritonitis.5) Patients with organic leasion of hepato-biliary-pancreatic (gallstone, hepatitis, pancreatitis)6) Patients with total construction of artificial anus.7) Patients with gastrointestinal hemorrhage, perforation and history of mechanical ileus.8) Patients with serious complications (interstitial pneumonia, diabetes mellitus, heart failure, renal failure, hepatic insufficiency)9) Patients who are administered antiparkinson drug.10) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy.11) Others, patients who are unfit for the study as determined by the attending physician. | |||
| Target sample size | 60 | |||
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| Name of lead principal investigator |
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| Organization | Osaka Police Hospital | ||||||
| Division name | Surgery | ||||||
| Zip code | 543-0035 | ||||||
| Address | 10-31 Kitayama-cho Tennouji-ku Osaka 543-0035,Japan | ||||||
| TEL | 06-6771-6051 | ||||||
| wakasugi@oph.gr.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Osaka Police Hospital | ||||||
| Division name | Surgery | ||||||
| Zip code | 543-0035 | ||||||
| Address | 0-31 Kitayama-cho Tennouji-ku Osaka 543-0035,Japan | ||||||
| TEL | 06-6771-6051 | ||||||
| Homepage URL | |||||||
| wakasugi@oph.gr.jp | |||||||
| Sponsor | |
| Institute | Osaka Police Hospital |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Tsumura company |
| Organization | |
| Division | |
| Category of Funding Organization | Profit organization |
| Nationality of Funding Organization | |
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| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Osaka Police Hospital |
| Address | 10-31 Kitayama-cho Tennouji-ku Osaka 543-0035,Japan |
| Tel | 06-6771-6051 |
| wakasugimasaki@gmail.com | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
| Institutions | 大阪警察病院(大阪)／Osaka Police Hospital(Osaka) |
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| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | pubmed.ncbi.nlm.nih.gov/32588153/ |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | pubmed.ncbi.nlm.nih.gov/32588153/ | ||||||
| Number of participants that the trial has enrolled | 32 | ||||||
| Results | The numbers of bowel movements per day on postoperative days (PODs) 1, 2, and 6 were significantly lower in the DKT group. The presence of the sensation of incomplete bowel evacuation on PODs 3 and 28 was significantly lower in the DKT group. There were no adverse events due to or suspected to be related to DKT. |
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| Baseline Characteristics | Patients undergoing colorectal surgery at the Osaka Police Hospital |
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| Participant flow | The patients were randomly assigned to either the DKT group or the control group. |
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| Adverse events | None |
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| Outcome measures | Primary endpoints were i) gastrointestinal symptoms (abdominal pain/distention) measured by the Visual Analogue Scale (VAS); ii) the sensation of incomplete bowel evacuation (yes/no); and iii) POD to confirm first evacuation, postoperative time to confirm first flatus, and the number of bowel movements per day. Secondary endpoints included quality of life (QOL) (acid reflux, abdominal pain, indigestion, diarrhea, and constipation) assessment using the GSRS questionnaire. Participants completed the questionnaire on the day of informed consent before the operation (about 2 weeks before surgery) and on PODs 3, 7, 14, 21, and 28. |
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| Recruitment status | Completed | ||||||
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009820 |
