Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Biliary Tract Neoplasms

Liver Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Liver Diseases

Biliary Tract Diseases

Hematinics

All Drugs and Chemicals

Other Dietary Supplements

Liver Extracts

Whey Protein

The first group (pre-hab) will receive both nutritional supplementation and a prehabilitation program.

Whey protein and dietary supplements in addition to pre-hab exercise

Whey protein and dietary supplements

minimum 4 weeks and maximum 8 weeks; 3 times a week

prehab exercise

Ayat Salman, MSccandidate

Prosanto Chaudhury, MD

1. To determine whether a combined nutritional support program and exercise-based prehabilitation is superior to nutritional support alone in increasing functional recovery and reducing post-operative morbidity after surgery for HPB malignancy.
2. To understand which measures of immediate surgical recovery are sensitive to prehabilitation interventions and predict change in later outcome measures.

Patients scheduled for elective liver resection be will be approached andrandomized to one of two groups using a computer generated block randomisation scheme. The first group (pre-hab) will receive both nutritional supplementation and a prehabilitation program as outlined below. The second group (nutrition) will receive only nutritional supplementation. Both groups will be given a post-operative exercise program.

Once randomized, the subjects will be called by the research co-ordinator and an appointment will be made for the initial assessment. After the study is explained and consent obtained, subjects will be tested on 6MWT, followed by a 30 minute rest period during which various questionnaires assessing physical activity, quality of life, fatigue and nutritional status will be completed with the aid of the coordinator.

The prehabilitation program will last a minimum of four weeks and a maximum of 8 weeks.

Surgery will be performed by one of the HPB surgeons at the McGill University Health Center. Surgical approach, including laparoscopic or open surgery will be at the discretion of the surgeon. Perioperative care will follow an Enhanced Recovery After Surgery (ERAS)-based clinical care pathway27, 28, a fast-track care plan including patient education, afferent neural blockade, multimodal analgesia, early oral intake and mobilization, early removal of catheters and drains, and a planned 6-8 day hospital admission. This pathway has already been implemented at the Royal Victoria Hospital as part of standard patient care.

Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer

Improving Outcomes in Patients With Hepatobiliary Cancers With a Nutritional and Physical Conditioning Pre-habilitation Program

The primary outcome is patient-relevant, functional walking capacity as measured by the six-minute walk test (6MWT). The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living

Postoperative complications including surgical site infection, other infectious complications (such as pneumonia, urinary tract infection, line sepsis), bile leak, hemmorrhage, deep vein thrombosis, etc., will be recorded and scored using the Clavien Classification.

Health-related quality of life (HRQL) as measured by the acute (1 week recall period) SF-36 health survey. The SF-36 is the most widely used HRQL measure and has been validated for surgical population; Canadian norms are also available.

Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. The CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week.

Depression and anxiety will be assessed by The Hospital Anxiety and Depression Scale (HADS), a 14-question measure with seven items each for depression and anxiety. HADS generates separate scores for anxiety and depression as well as a combined score of psychological distress.

Fatigue will be assessed using a visual analog scale (1-10) and the Brief Fatigue Inventory (BFI). The BFI assesses the level of fatigue and its impact on activities of daily living44

Nutritional status will be assessed through subjective and objective evaluations.Body composition will be measured by bioimpedance assay.Assessment of usual food intake will be performed using the 3-day, 24-hour food recall method. The scored Patient Generated Subjective Global Assessment (sPG-SGA) is a validated questionnaire used to assess the nutritional and functional status of cancer patients.

McGill University Health Centre/Research Institute of the McGill University Health Centre

HPB and Transplant Surgeon

Rare Diseases

Biliary Tract Cancer

Antineoplastic Agents

Gemcitabine

Antimetabolites

Treatment will be delivered as a 3-week cycle.

1. Gemcitabine 1000 mg/m2 iv on day 1, 8
2. S-1 60 mg/day po on day 1-14

Gemcitabine, and S-1

Dae Young Zang, MD, PhD

This study will conduct a phase II study of gemcitabine and S-1 as first-line chemotherapy in patient with advanced biliary tract cancer

Biliary-tract cancer (BTC) is invasive carcinoma that originates from the epithelial lining of the gallbladder and bile ducts. BTC include cholangiocarcinoma (intrahepatic, perihilar, and distal biliary-tree tumor) and carcinoma arising from the gallbladder.

Surgical resection of the primary tumor is potentially curative for BTC, but less than a quarter of patients are eligible for resection at presentation. Systemic chemotherapy is the principal treatment method for patients with unresectable or metastatic BTC.

Gemcitabine is a promising agent, which has shown efficacy in biliary tract cancer. As a single-agent therapy, gemcitabine shows response rates of 8-36% in BTC\[4\]. In phase II trials with patients in advanced BTC, gemcitabine in combination with capecitabine or platinum analogues produced objective response rates of 26-50%.

The ABC-02 study reported a significant survival advantage for gemcitabine and cisplatin over gemcitabine alone in patients with advanced BTC (median overall survival 11.7 vs. 8.1 months; P \< 0.001).

Oral anticancer drug S-1 consists of the 5-FU prodrug tegafur with two biochemical modulators, 5-chloro-2,4-dihydroxypyridine (CDHP) and potassium oxonate (Oxo). S-1 monotherapy is active against advanced BTC with objective response rates of 21-35%, and phase II trials of S-1 in combination with gemcitabine reported objective response rates of 20-36%. Differences between trials in the doses and administration schedules of gemcitabine and S-1 may be reflected in the ranges of efficacy, dose-intensity, and rates of toxicity observed.

Even though the efficacy of gemcitabine and S-1 combination is evident for patients with advanced BTC in previous phase II trials, there was no clinical study investigating the efficacy of gemcitabine and S-1 combination for patients with advanced BTC when this study was started. Therefore, we conducted a phase II study to evaluate gemcitabine and S-1 combination as first-line chemotherapy for patients with advanced BTC.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer	NCT01542281	Colorectal Neop... Biliary Tract N... Liver Neoplasm	Whey protein an... prehab exercise	18 Years - 80 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre
Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer	NCT01542281	Colorectal Neop... Biliary Tract N... Liver Neoplasm	Whey protein an... prehab exercise	18 Years - 80 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre
Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer	NCT01542281	Colorectal Neop... Biliary Tract N... Liver Neoplasm	Whey protein an... prehab exercise	18 Years - 80 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre
Gemcitabine and S-1 for Advanced Biliary Tract Cancer	NCT02146703	Biliary Tract N...	Gemcitabine, an...	18 Years - 70 Years	Hallym University Medical Center
Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer	NCT01542281	Colorectal Neop... Biliary Tract N... Liver Neoplasm	Whey protein an... prehab exercise	18 Years - 80 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre

Spots Global Cancer Trial Database for biliary tract neoplasm