Oral Rehydration Therapy for Short Hydration in Chemotherapy With CDDP Plus GEM for Biliary Tract Cancer

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Brief Title

Oral Rehydration Therapy for Short Hydration in Chemotherapy With CDDP Plus GEM for Biliary Tract Cancer

Official Title

The Feasibility Study of Oral Rehydration Therapy for Short Hydration in Chemotherapy With Cisplatin Plus Gemcitabine for Biliary Tract Cancer

Brief Summary

      The objective of this study is to evaluate the safety and feasibility of oral rehydration
      therapy for short hydration in patients with biliary tract cancer who will undergo the
      chemotherapy including gemcitabine and cisplatin.
    

Detailed Description

      A large amount of fluid infusion is required to load for the prevention of renal dysfunction
      by Cisplatin in combination of GC therapy. There is a problem infusion time is take a long
      time for this. In many institutions in Japan, GC therapy is performed over 3 hours or more,
      longer than original method in the ABC-002 trial. Oral rehydration therapy is a therapy that
      performs prevention or treatment of dehydration by the ingestion of oral rehydration
      solution, which is adjusted the concentration of the electrolyte and glucose to absorb good
      efficiency from the gastrointestinal tract. Oral rehydration therapy (ORT) is a therapy that
      performs prevention or treatment of dehydration by the ingestion of oral rehydration
      solution, which is adjusted the concentration of the electrolyte and glucose to absorb good
      efficiency from the gastrointestinal tract. Many reports suggest ORT may substitute for
      infusion therapy. Herein, the investigators planned the study to examine the safety of
      replacing the fluid infusion by oral rehydration expecting to shorten the time to drip.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Completion rate during the 12 weeks in the short hydration group

Secondary Outcome

 Rate of renal toxicity

Condition

Biliary Tract Cancer

Intervention

Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS)

Study Arms / Comparison Groups

 Oral rehydration group(Short Hydration)
Description:  Gemcitabine; gemzer Cisplatin;Cispulan Oral Rehydration Solution(ORS);OS-1
Short hydration via oral rehydration solution (OS-1)
Cisplatin plus gemcitabine will be administered via infusion as follows; 500 ml of 0.9% saline including cisplatin (25 mg per square meter of body-surface area) over 1 hour followed by 250 ml of 0.9% saline including gemcitabine over 30 minutes. Before and after the infusion, each 500ml bottle of oral rehydration solution (OS-1) will be taken respectively.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

May 22, 2013

Completion Date

July 7, 2016

Primary Completion Date

January 7, 2016

Eligibility Criteria

        Inclusion Criteria: 1. Patients with histological or cytological diagnosis of biliary tract
        cancer who haven't received cisplatin previously 2. Patients who is planned to receive
        chemotherapy including gemcitabine and cisplatin for biliary cancer for more than 12 weeks
        3. Older than 20 years old 4. Eastern Cooperative Oncology Group Performance status of 0 or
        1 5. Adequate main organ function 6. Fully oral intake ability to drink 500ml of solution
        before chemotherapy 7. Estimated life expectancy no less than 3 months 8. Written informed
        consent

        - Exclusion Criteria: 1. Patients who received cisplatin previously 2. Radiological and
        clinical evidence of pulmonary fibrosis or interstitial pneumonia 3. Patients with
        uncontrolled diabetes mellitus or severe liver dysfunction or unstable angina or myocardial
        infarction within 3 months 4. Patients with serious infection 5. Pregnant or lactating
        female or patients who wish pregnant 6. Patients having severe allergy 7. Patients with
        other serious comorbid diseases 8. Patients with severe psychological disease 9. Patients
        with uncontrollable watery diarrhea 10. Patients with moderate or severe ascites /pleural
        effusion 11. Patients with severe psychological disease 12. Patients who are positive for a
        test of hepatitis B virus surface antigen (HBs antigen) without controlled with entecavir
        13. Patients who is judged as an inappropriate case by the investigator

        -
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Hiroaki Nagano, MD, PhD, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT01917617

Organization ID

KHBO1302

Secondary IDs

UMIN000010695

Responsible Party

Sponsor

Study Sponsor

Kansai Hepatobiliary Oncology Group


Study Sponsor

Hiroaki Nagano, MD, PhD, Study Director, Osaka University Graduate School of Medicine


Verification Date

May 2017