Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

Sarcopenia

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Pancreatic Cancer

4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support

Prehabilitation program

perioperative immunonutrition by ORAL IMPACT

Oral Impact

Mehdi ELAMRANI, MD

Major digestive surgery is associated with a significant rate of postoperative complications. To improve postoperative outcome, efforts are focused on postoperative course leading to the concept of rehabilitation. However, the rehabilitation concept does not allow to improve muscular and functional reserves at the time of surgery. Sarcopenia is a condition characterized by loss of skeletal muscle mass and function. Also, the prevalence of sarcopenia in patients with cancer is high and has a prevalence of around 25% in patients with pancreatic cancer, with a considerable impact on postoperative and survival outcomes.

The hypothesis is the preoperative management of sarcopenia by a rehabilitation program could improve patients' operative outcomes by reducing the rate of postoperative complications.

Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer

Prehabilitaion Program for Sarcopenic Patients Prior to Pancreaticoduodenectomy for Periampullary Malignant Tumors

Pancreatic fistula as defined by the International Study Group of pancreatic Fistula (ISGPF)

Grade \> IIIa (Clavien-Dindo classification)

self questionnaire to measure opinion with respect of rehabilitation program

EVAN-G general patient satisfaction questionnaire consisting of 26 items divided into 6 sub-sections scoring on a scale from 0 to 100. It is designed to report perioperative problems.

French self-administered instrument for measuring hospitalized patients' satisfaction based on the patient's point of view. QSH contained 45 items describing 9 dimensions, leading to 2 composite scores (staff and structure index)

The QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The questionnaire includes one global health status/QoL scale, five functional scales and three symptom scale. Each scale is scored from 0 to 100. A high score on a scale indicate a good outcome for the dimension of QoL.

Groupement Interrégional de Recherche Clinique et d'Innovation

Santelys Association

University Hospital, Lille

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Amino Acids

Other Dietary Supplements

Caseins

Arginine

Omega 3 Fatty Acid

Immunonutrition enriched with omega-3 fatty acids, arginine, nucleotides, and soluble fibre. Main source of protein is arginine and casein.

A balanced nutritional supplement that enhance body natural defence and support recovery during illness.

A serving of 74 gm (containing 309 kcal ) of oral impact mixed with 250 ml of water. Each participant will receive total of 3 servings daily for 7 days pre operatively .

A serving of 66.8 gm ( containing 304 kcal ) of nutren optimum mixed with 300 ml of water.Each participant will receive total of 3 servings daily for 7 days pre operatively .

Nutren Optimum

Manivaasan Pannirselvam, Dr

Wong Pak Kai ( Michael), Dr

Wong Pak Kai ( Michael ), Dr

Siti Rahmah Binti Hashim Isa Merican, Dr

Muhammad Faeid Bin Othman, Dr

Nor Syarahani Binti Jusoh, Ms

Muhammad Faeid BIn Othman, Dr

Nor Syarahani Binti Jusoh, Dr

This is a randomised controlled clinical trial . The investigators aim to compare the effects of preoperative immune modulating enteral nutrition and standard oral nutrition supplement on clinical outcomes of the patients undergo colorectal cancer surgery.

The main questions it aims to answer are:

1. Does immunonutrition preoperatively facilitate earlier return of Gastrointestinal function?
2. Does immunonutrition significantly reduce risk of post-operative surgical site infections?
3. Does immunonutrition significantly reduce duration of hospital stay in patients undergoing colorectal surgery?

Immunonutrition can be defined as modulation of either the activity of the immune system, or modulation of the consequences of activation of the immune system, by nutrients or specific food items fed in amounts above those normally encountered in the diet.

Oral IMPACT is readily available immunonutrition consist of 3.3 g of arginine,0.8 g of omega-3 fatty acids and 3.0 g of nucleotides per servings.

Nutren Optimum is a balanced nutritional supplement that enhance body natural defence and support recovery during illness. However, it does not consist all the component of immunonutritons. Hence , Oral IMPACT will be used as study sample on experimental arm whereas Nutren optimum will be used as study sample on control arm.

Partipicant will be randomised into this two arm and then they will consume the respective arm study material for total of 7 days preoperatively.

Data will be collected in post operative period and will be analysed.

Colorectal cancer (CRC) is the commonest cancer in Malaysian men and the second most common cancer in Malaysian women, accounting for age standardized rate of 14.8 and 11.1 incidences per 100,000 population respectively.

Oncological colonic resection is one of mainstay treatment modality for colorectal tumour. Major surgery precipitate release of stress hormones, inflammatory mediators and metabolic changes resulting in significant catabolic phenomena. This sequentially imposed significant dysfunction of the overall host homeostasis, defence mechanism and inflammatory response. Hence, the major setbacks of colorectal surgery are delay return of normal bowel physiology state, post-operative complications and prolonged hospital stay. This affects patients physiologically and psychologically.

Traditionally , patients undergo major abdominal surgery will be kept nil per oral for 6 to 12 hours prior to operation. Post operatively, parenteral or enteral fluids given until bowel function returns to normal. Fortunately, the introduction of the Enhanced Recovery After Surgery (ERAS) programs in last decade has led to enhanced in the recovery of patients postoperatively. The main aspects of substantial improvements in the care of postoperative patients include early initiation of oral intake as soon as possible, integration of nutrition support ,metabolic control and early mobilisation.

As nutritional status plays a significant role to influence the clinical outcomes, nutrition support has been widely used for elective colorectal surgery patients. Literature reported that nutritional risk rate of cancer patients to be 26% to 76 %, higher than of general patients.

Immunonutrition has been used as therapeutic options for peri-operative nutritional management in patients undergoing surgery. The nutrients of immunonutrition formula usually include arginine, omega-3 fatty acids, glutamine and nucleotides.

The current international guidelines recommend that patient's with high risk of malnutrition should be given immunonutrition in perioperative period prior to major oncologic surgeries.These guidelines are based on randomized controlled trials demonstrating a reduction in the rate of post-operative complications.

Oral IMPACT is readily available immunonutrition consist of 3.3 g of arginine,0.8 g of omega-3 fatty acids and 3.0 g of nucleotides per servings. It comes in sachet form which mixed with water prior to consumption. Multiple randomised controlled trial supported Oral IMPACT as immunonutrition.

Nutren Optimum is a balanced nutritional supplement that enhance body natural defence and support recovery during illness. However, it does not consist all the component of immunonutritons. Hence , Oral IMPACT will be used as study sample on experimental arm whereas Nutren optimum will be used as study sample on control arm.

In nutshell , it is important for proper perioperative nutritional support for patients scheduled for colorectal surgery. It remain as major advantage for successful procedure.

In the light of this guideline investigators aimed to compare the effects of preoperative immune modulating enteral nutrition and standard oral nutrition supplement on clinical outcomes of the patients undergo colorectal cancer surgery.

Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.

A Randomized Controlled Trial on Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.

all IPD that underlie results in a publication

To compare the time of the first flatus and first bowel evacuation between Oral Impact® and Nutren Optimum ® when consumed in the preoperative in those undergoing colorectal surgery.

To associate the difference on post operative surgical site infection in between those consuming Oral Impact® versus Nutren Optimum ® in the preoperative period after colorectal surgery.

To study on the differences on duration of hospital stay after colorectal surgery in those consuming Oral Impact® and Nutren Optimum ®

Hospital Universiti Sains Malaysia

Dr Manivaasan Pannirselvam

Infections

Cholangiocarcinoma

Communicable Diseases

Bile Duct Neoplasms

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

oral supplement for 5 days(1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA

Oral IMPACT

Katsunori Furukawa, MD

The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with major hepatectomy.

The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after hepatectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.

Object of this study is to investigate the effects of preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after hepatectomy.

Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy

Effects of Preoperative Immunonutrition on Infectious Complication and Th1/Th2 Differentiation in Patients Undergoing Hepatectomy

Chiba University

MD, PhD

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Oral IMPACT (1 L/day) for 5 days before surgery and by enteral feeding after surgery

Oral IMPACT 1000ml/day for 5 days (1 L/day) before surgery

Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery

Daisuke Suzuki, MD

The purpose of this study is to investigate whether perioperative immunonutrition has additional effects on cell-mediated immunity in patients undergoing pancreaticoduodenectomy.

The investigators reported that perioperative immunonutrition had no additional effects compared with preoperative immunonutrition in patients underwent colorectal surgery (Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002; 132:805-14, PMID: 12464864). Object of this study is to investigate the additional effects of perioperative immunonutrition on cell-mediated immunity and incidence of infectious complication after pancreaticoduodenectomy.

Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy

Additional Effects of Perioperative Immunonutrition on Th1/Th2 Differentiation in Patients Undergoing Pancreaticoduodenectomy

Mouth and Tooth Diseases

Head and Neck Neoplasms

Mucositis

Gastroenteritis

Mouth Diseases

Stomatognathic Diseases

Acute Graft Versus Host Disease

Pharmaceutical Solutions

Central Nervous System Depressants

Benzocaine

Tannic Acid

The oral supplement is a 74g sachet containing 302 kcal and 16.7g proteins as well as immunonutrients such as L-Arginine, ARN and omega-3.

The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.

The patients will benefit in each case from a similar energy supplement (either Oral Impact or placebo) during the 5 days preceding the course of chemotherapy. They will receive the supplement 3 times per day at 10am, 3pm and 5pm outside of their meals. In total, the patients will take the supplements for 15 days (3 courses of 5 days). If the patient has difficulty taking the treatment orally, it can be given via an enteral tube (nasogastric tube or percutaneous gastrostomy). All patients in the protocol will systematically receive a dietetic consultation.

This consultation by a dietician will detect malnutrition and result in nutritional counsel if necessary (advice re. enrichment of diet, CNO without immunonutrients, artificial nutrition). Follow-up appointments with a dietician will be organised every 3 weeks to maintain adherence to the suggested dietary changes.

Placebo

This randomised, double-blind study will compare an oral immunomodulatory solution to a placebo for the prevention of acute severe mucositis in head and neck cancer patients treated surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of 25% of severe acute mucositis in experimental arm.

Randomised Study of Mucositis Prevention After Radiochemotherapy Treatment for Head and Neck Cancer

Phase III Multicenter, Randomised and Double-blind Study Comparing an Oral Immunomodulatory Solution Versus a Placebo in Preventing Severe Acute Mucositis in Head and Neck Cancer Patients Treated Surgically and Concomitantly With Radiochemotherapy

tolerance of treatment with the CTCAE (Common Terminology Criteria for Adverse Events)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer	NCT04469504	Sarcopenia Pancreatic Canc...	Prehabilitation... Oral Impact	18 Years -	University Hospital, Lille
Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer	NCT04469504	Sarcopenia Pancreatic Canc...	Prehabilitation... Oral Impact	18 Years -	University Hospital, Lille
Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.	NCT06128798	Colorectal Neop...	Oral Impact Nutren Optimum	18 Years -	Hospital Universiti Sains Malaysia
Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.	NCT06128798	Colorectal Neop...	Oral Impact Nutren Optimum	18 Years -	Hospital Universiti Sains Malaysia
Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy	NCT01256047	Bile Duct Cance...	Oral IMPACT	18 Years -	Chiba University
Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy	NCT01969110	Pancreatic Tumo... Bile Duct Tumor	Oral IMPACT	18 Years - 80 Years	Chiba University
Additional Effects of Perioperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy	NCT01969110	Pancreatic Tumo... Bile Duct Tumor	Oral IMPACT	18 Years - 80 Years	Chiba University
Randomised Study of Mucositis Prevention After Radiochemotherapy Treatment for Head and Neck Cancer	NCT01149642	Severe Acute Mu... Head and Neck C...	Oral Impact Placebo	18 Years - 75 Years	Institut du Cancer de Montpellier - Val d'Aurelle
Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer	NCT04469504	Sarcopenia Pancreatic Canc...	Prehabilitation... Oral Impact	18 Years -	University Hospital, Lille

Spots Global Cancer Trial Database for oral impact

Every month we try and update this database with for oral impact cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for oral impact

Every month we try and update this database with for oral impact cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for oral impact cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.