Examination to examine the effect of omega-3 fatty acids on chemotherapy after surgery of biliary tract cancer

JRCT ID: jRCTs051180007

Registered date:08/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Biliary tract (bile duct (Intrahepatic, perihilar, distal), gallbladder, ampulla of vater) cancer
• Date of first enrollment: 15/10/2018
• Target sample size: 55
• Study type: Interventional
• Intervention(s): We can ingest 2 mg of omega-3 fatty acid daily required by ingesting Lotriga 1 capsule once a day. Continue oral administration of 1 capsule (2 mg) once daily with Lotriga during chemotherapy (TS-1 4weeks intake, 2weeks withdrawal x 4 cool: total of 24 weeks).

Outcome(s)

• Primary Outcome: Possibility to complete postoperative adjuvant chemotherapy by administering omega-3 fatty acid during adjuvant chemotherapy after surgery of biliary tract cancer

Secondary Outcome

1) presence or absence of cholangitis
2) time to recurrence or metastasis
3) Amount of change in nutritional status (albumin, total protein, body weight)
4) Amount of change in lymphocyte blastogenesis during the treatment period
5) Amount of immunological change of intestinal mucosa during treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Patients who satisfy all the following criteria are targeted.
1) postoperative endopathological diagnosis of adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma), adenosquamous carcinoma, confirmed to be extrahepatic bile duct carcinoma, gallbladder carcinoma, carcinoma of Vater large intestine, intrahepatic bile duct It is cancer. However, when the pathological diagnosis is mixed type, papillary adenocarcinoma, tubular adenocarcinoma, adenosquamous cell carcinoma are predominant.
2) Postoperative pathological diagnosis satisfies the following in UICC stage classification (7th edition).
Extrahepatic bile duct carcinoma (hepatic portal region, distal part), gallbladder carcinoma, Vater huge tumor cancer: T2-4, N0, M0 or T1-4, N1, M0
Intrahepatic cholangiocarcinoma: T1-4, N0-1, M0
If the cancer type is duplicated, the eligibility is judged at the stage of the most advanced stage cancer type.
3) The age at registration is over 20 years old and under 80 years old.
4) Performance status (PS) (ECOG) is 0 or 1 (PS must be listed in the medical record).
5) There is no distant metastasis at the CT or MRIa) before postoperative surgery and there is no pleural effusion or ascites at or above the moderate amount b).
a) In cases where qualification can be evaluated by obtaining inspection images done at other hospitals, the examination done at other hospitals is also acceptable.
b) Ascites more than moderate means the case of crossing over the pelvic cavity as a guide, with pleural effusion above the moderate level standing When the pleural volume on a simple chest x-ray exceeds 1/3 of either left or right lung field As a guide.
6) If any one of the following operations is performed on the primary lesion, and in the case of extrahepatic cholangiocarcinoma, gall bladder cancer, Vaters extensive tumor, intrahepatic cholangiocarcinoma with proliferation of the hepatic duct, D1 or more lymph nodes Neck cleansing is done (Biliary tract cancer handling regulation 5th edition). With intrahepatic cholangiocarcinoma without progress of the hepatic duct, the presence or absence of lymph node dissection is not required.
(1) pancreaticoduodenectomy (including pylorus-preserving pancreaticoduodenectomy, subarachicular-preserved pancreatic head resection)
(2) hepatic lobectomy and biliary tract reconstruction
(3) biliary resection
(4) palliative surgery including biliary tract recon-struction
7) There is no history of chemotherapy, radiation therapy, including treatment for other cancer types.
8) It is within 2 weeks (14 days) and 10 weeks (70 days) after surgery (it can be registered from the same day after 2 weeks of operation day to the same day after 10.
9) Sufficient oral intake is possible.
10) The surgical wound is closed and the drain is pulled out.
11) There is no watery diarrhea.
12) The latest inspection value within 14 days before registration (same day as two weeks before the registration day is acceptable) satisfies all of the following.
(1) Number of neutrophils is more than 1,200/mm3
(2) Platelet count is more than 10x10000/ mm 3
(3) Hemoglobin is more than 8.0 g/dL
(4) Total bilirubin is less than 2.0 mg/dL
(5) AST (GOT) is less than 100 IU/L
(6) ALT (GPT) is less than 100 IU/ L
(7) Serum creatinine is less than 1.2 mg / dL
(8) Creatinine clearance is more than 40 mL / min
The creatinine clearance is estimated by the Cockcroft-Gault formula to be 50 mL / min or more. If the estimated value is less than 50 mL / min, it is qualified if it is confirmed that it is 50 mL / min or more as measured value. The Cockcroft-Gault formula is shown below.
Male: Ccr = ((140-age) x weight (kg)) / (72 x serum Cr value (mg / dL))
Female: Ccr = 0.85 x ((140-age) x weight (kg)) / (72 x serum Cr value (mg / dL))
13) About participation in the examination Informed consent was obtained from the patient himself.
((Setting reason))
1) to 12) It was set to be the starting criteria for postoperative adjuvant chemotherapy.
13) Set to confirm the patient's free will.

Exclude criteria

Patients applicable to even one of the following are excluded.
1) Patients with drug hypersensitivity such as allergies
2) Concurrent duplicate cancers / multiple cancers and metachronous duplicate cancers with no disease duration within 5 years / multiple cancers, with carcinoma in situ (judged to be cured by topical treatment) Intraepithelial carcinoma) or lesions equivalent to carcinoma in the mucosa are not included in active duplicated cancers).
3) Infectious diseases requiring systemic treatment (excluding viral hepatitis).
4) It has a fever over 38 deg C at the time of registration.
5) A woman who is pregnant, has a possibility of pregnancy, or is breastfeeding. A man who wishes to become a partner's pregnant.
6) Psychosis or psychiatric symptoms are merged and it is judged that participation in the examination is difficult.
7) Complicated with severe liver or kidney dysfunction.
8) Diabetes mellitus with poor control or hypertension is complicated.
9) Unstable angina (angina with onset or seizure worsening within the last 3 weeks), or have a history of myocardial infarction within 6 months.
10) Successful use of flucytosine, phenytoin, warfarin potassium is required.
11) Interstitial pneumonia, pulmonary fibrosis, advanced emphysema is complicated.
12) LOTRIGA or EPADEL has already taken inside from this study.
13) Patients with bleeding
14) In addition, patients judged inappropriate by the person in charge of this study
((Setting reason))
1) It was set because there was a possibility that it would not be applicable for postoperative adjuvant chemotherapy.
2) ~ 13) It was set to ensure patient safety.
14) In order to secure the safety of the subjects to be studied, and to properly carry out the test, we set up to leave room for excluding inappropriate patients by the attending physician.

Related Information

• Primary Sponsor: Tsugawa Daisuke
• Secondary ID(s): UMIN000031247