Investigation of clinical effect of vitamin D supplement therapy for pancreatic cancer

JRCT ID: jRCTs051210021

Registered date:10/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 10/05/2021
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Within 14 days of enrollment, alfacalcidol will be started as vitamin D replacement therapy. The specific dosage of alfacalcidol is 4.0 ug per day, and this dosage is administered orally once a day after breakfast. This dosage should be continued until the day before surgical removal of the pancreatic cancer specimen.

Outcome(s)

Primary Outcome

Pathological evaluation of the number of alfa-SMA positive cells in resected pancreatic cancer specimens
(Number of alfa-SMA positive cells in five randomly selected fields of view at 200x in stromal cells in pancreatic cancer tissue)

Secondary Outcome

Examination of the relationship between the number of alfa-SMA positive cells and the following items
- Vitamin D administration period.
- Serum vitamin D concentration (25(OH) vitamin D, 1,25(OH)2 vitamin D)
- Background factors; age, gender, tumor markers (CEA, CA19-9), preoperative treatment, disease stage, and disease type
Rate of change in bone mineral density.
Adverse events that occurred during the study.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients with confirmed pancreatic cancer classified as resectable pancreatic cancer who are scheduled to undergo surgery in 4 to 8 weeks after 5 to 8 weeks of preoperative systemic chemotherapy or chemoradiation.
(2) Age at the time of consent: 20 years or older
(3) PS: 0-1 (ECOG grade)
(4) Patients with major organ function (bone marrow, liver, kidney, lung, etc.)
-White blood cell count: 3,500/mm3 or higher, neutrophil count: 2,000/mm3 or higher,
-platelet count: 100,000/mm3 or higher.
-Hemoglobin: 9.0 g/dL or higher
-Total bilirubin: 2.0 mg/dL or less (However, 3.0 mg/dL or less for patients undergoing biliary drainage for obstructive jaundice caused by tumor)
-AST(GOT), ALT(GPT): 150U/L or less
-Serum creatinine level: 1.2 mg/dL or less, creatinine clearance: 60 mL/min or more (estimation by the Cockcroft-Gault formula is acceptable)
(5)Patients whose written consent to participate in this study has been obtained.

Exclude criteria

(1) Patients with the following electrolyte abnormalities:
1) Hypercalcemia (corrected serum Ca level of 11.5 mg/dl or higher (equivalent to Grade 2 in CTCAE ver4.0))
2) Hyper PTH, PTHrPemia (above the standard value)
(2) Patients who are using or have taken drugs, supplements, or health foods related to bone metabolism (bisphosphonate, vitamin D, calcium, phosphorus, etc.)
(3) Patients who are using steroids
(4) Patients who have difficulty with oral treatment
(5) Patients with severe mental disorders
(6) Patients with severe drug hypersensitivity
(7) Patients with pregnant or wishing to pregnant
(8) Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for the safe conduct of this study.

Related Information

• Primary Sponsor: Eguchi Hidetoshi