Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Body Weight

Hematologic Neoplasms

Hematologic Diseases

Other Dietary Supplements

All Drugs and Chemicals

Inulin

Placebo control is a compounded made-up shake that is traditionally used by the Haematology ward to supplement patients receiving HSCT. The control provides an equivalent of 500kcals and 20.6g protein, 3.4g fiber per day. The participants will be randomly assigned to consume the control twice daily for the duration of 7 days prior to the admission to the day of discharge.

Traditional Control

The product to be studied is a standard polymeric formula. It is intended to provide 500cals, 18.4g protein, and 5g fiber per day. The fiber contained is mostly presented in the form of soluble fiber (inulin, fructo-oligosaccharide). The participants will be randomly assigned to consume the intervention twice a day for the duration of 7 days prior to the admission to the day of discharge.

Oral Nutritional Supplement

Renying Xu

Malnutrition is common after haematopoietic stem cell transplantation (HSCT), and is a well-known prognostic factor for survival. HSCT-associated treatments are metabolic and digestively intolerant, hence can induce a significant reduction in oral intake. Thus weight loss, as well as a reduction in serum albumin, and pre-albumin levels, are frequent following HSCT. Although the gut remains functional, sore mouth, mucositis, dysphagia, nausea, vomiting, and diarrhoea will inevitably hinder the implementation of enteral nutrition (EN), thus leading to a deficit between daily intake and requirement. Side effects of chemotherapy and antibiotics in combine will contribute to the alteration of intestinal flora on top of the existing gut symptoms, further impairing nutrient digestion and absorption.

Oral nutritional supplements (ONS) are foods for special medical purposes (FSMP) that are specially formulated for oral nutritional support. Limited retrospective studies performed in Western countries have found that ONS was tolerable for HSCT patients eligible for EN, however, the data is sparse in China to support the safety of usage amongst this population. On the other side, what is less clear is the nature of soluble fiber upon the intestinal microenvironment in patients undergoing HSCT. It would be worthwhile to investigate the impact of fibre-modulated ONS on gut function and symptoms.

The study is a prospective study. All the participants will be recruited from a single research center (Renji Hospital). The participants will be randomized into two groups: traditional treatment or ONS. Ensure complete (Abbott), which contains soluble dietary fiber such as fructo-oligosaccharide (FOS) and inulin, will be served as the ONS for testing.

The primary aim of the study is to examine the between-group change from baseline body weight at 28 days post-transplantation. The secondary outcomes include the within-group and between-group dynamic change in the peri-transplant period for the following: body weight, fat-free mass, circumference, handgrip test, and patient-generated global subjective assessment. The tolerability of supplementing ONS and its' effect on gut function as well as on infection rate is also of interest.

Standard Operating Procedures:

The study is located in Renji Hospital Stem Cell Transplant Unit, including Haematology Outpatient Department and Clinical Nutrition Department. All the patients aged between 18 and 75 years planned for HSCT and who are able to understand and sign an informed consent form are eligible for the study. The potential participants will be provided with the information sheet by the dietitian on the day of their outpatient pre-assessment visit. Each participant will be allocated with a study-specific code to protect their confidentiality. After recruitment, the participants will be asked to consume either the placebo control OR the ONS for testing, intended for supplementation for the duration of 7 days prior to HSCT admission. Anthropometry, biochemistry, and functional assessments are planned at four time points: before admission (baseline), the day of transplantation (D0), 14 days post-transplantation (D14) and 28 days post-transplantation (D28). In addition, nutritional intakes and gut assessments will be collected for the duration of the whole admission. If a subject is discharged home before D14 or D28, then these will be attempted at the appropriate time when the patient attended Haematology Outpatients for medical follow-up visits. Teleconsultation might be involved if the visit is not possible. All the data will be stored in an electronic database. It will be password protected with access only restricted to major investigators. All adverse events occurring within the trial will be collected at each visit for assessment of safety.

Sample Size Assessment:

A total number of 100 participants is determined necessary to demonstrate an effect. This sample size is designed to provide 85% power to detect a 1.2kg difference in body weight using an alpha=0.05(two-sided) to account for comparisons.

Plan for missing data:

A variable could be reported as missing by reasons possibly associated with logistic issues or participants declined to take the measurements. Strategy to minimize missing data includes setting up planning and time schedule in the Excel sheet to keep all the investigators notified.

Statistical Analysis Plan:

The demographic and clinical characteristics of patients will be summarized using descriptive statistics. Data analysis will be carried out using Statistical Analysis System (SAS) 9.4. Statistical analysis software. The mean or median change in continuous variables between the group by time points is assessed using t-test or Wilcoxon's rank sum test. Changes in categorical variables is assessed using Pearson chi-square or McNemar's test. Analysis of covariance or Analysis of variance might be applied as needed.

Impact of Oral Nutritional Supplements on Patients Undergoing Haematopoietic Stem Cell Transplantation

Impact of Oral Nutritional Supplements on Nutritional, Gut Functional and Clinical Outcomes: a Randomized Controlled Trial in Patients Undergoing Haematopoietic Stem Cell Transplantation

Calf circumference is assessed in centimeter

Patient-Generated Subjective Global Assessment (PG-SGA) is an universally used nutritional assessment tool. It is assessed in percentage based on the rated scores.

The diversity is assessed through faecal, blood and urine sample

Gut symptoms is assessed through the presence of diarrhoea and bloating in percentage

RenJi Hospital

Head and Neck Neoplasms

Flavonoid

Omega 3 Fatty Acid

Anthocyanidin

the intervention group received ONS which contained immunonutrients (omega 3 and anthocyanin)

the control group received standard ONS (isocaloric)

1 serving of ONS immunonutrients which is 57 grams of ready-to-brew powder yields 200 ml of a liquid formula containing 251 kcal energy (1.26 kcal/ml), 9 grams protein (14%), 94 mg omega-3, and 20 mg anthocyanins.

immunonutrients oral nutritional supplements

1 serving of standard ONS which is 57 grams of ready-to-brew powder yields 200 ml of liquid formula containing 258 kcal energy (1.26 kcal/ml), 5 g (7.5%) protein , 7 g (24%) fat, 43 g (68%) carbohydrate

standard oral nutritional supplements

Fuadiyah Nila, MPH

Fuadiyah Nila

The goal of this clinical trial is to compare the effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on nutritional status and inflammatory response in head and neck cancer patients receiving radiotherapy. The main questions it aims to answer are:

* Is there any effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on the nutritional status?
* Is there any effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on inflammatory response?

Participants will participants will receive ONS in powder form ready to brew as much as 2 servings per day for 3 weeks.

Researchers will compare the effect of giving ONS containing immunonutrients compared to standard ONS to see the effect on nutritional status and inflammatory response

The intervention group received ONS which contained immunonutrients with a composition consisting of purple sweet potato flour, egg white flour, whey protein, olive oil, omega 3 powder, sugar, and creamer. While the control group received a placebo in the form of standard ONS (isocaloric) with a composition of powdered skim milk, coconut oil, sugar, maltodextrin, and creamer.

Administration of ONS Based on Purple Sweet Potato in Head and Neck Cancer Patients With Radiotherapy

Effect of Local Food-Based Oral Nutritional Supplements (ONS) Containing Immunonutrients in the Form of Anthocyanin and Omega-3 on Nutritional Status and Inflammatory Response in Head and Neck Cancer Patients Receiving Radiotherapy

The differences in body weight after and before the intervention was given. Weight in kilograms will be measured with digital scales Omron Type HBF 378.

Calculation of nutritional status using the ratio of body weight (kg) to height squared (m2), where body weight is measured using an digital scales Omron Type HBF 378 and height is measured with a stadiometer.

the circumference of the left upper arm, measured at the mid-point between the tip of the shoulder and the tip of the elbow (olecranon process and the acromion). MUAC is measured using a metline in centimeters.

a simple and reliable measurement of maximum voluntary muscle strength, that is measured with handgrip dynamometer in kilograms (kg) unit.

Gadjah Mada University

University of Brawijaya

Digestive System Diseases

Nervous System Diseases

Rare Diseases

Stomach Neoplasms

Sarcopenia

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

In the oral nutritional supplement group, in addition to diet, and patients will also consume enteral nutrition powder (500 ml/d, 500kcal/d) lasted for 6 months after discharge.

In the control group, patients will receive nutrition counseling in addition to diet.

Tingting Gao, MS

Xinying Wang, MD

Da Zhou, MD

Gastric cancer patients after total gastrectomy will be randomized to oral nutritional supplement group or control group at discharge. Patients will receive 6 months of oral nutritional supplement or normal diet after discharge. The primary and secondary outcomes will be collected.

Gastric cancer patients after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to oral nutritional supplement (ONS) group or control (C) group after discharge. In the ONS group, in addition to diet, and patients will also consume enteral nutritional powder (500ml/d，500kcal/d) lasted for 6 months. In the C group, patients will receive normal diet. Both groups will receive nutrition counseling.

The primary and secondary outcomes will be collected.

ONS in Gastric Cancer After Total Gastrectomy

Effect of Oral Nutritional Supplement on Nutritional Status and Clinical Outcome in Gastric Cancer Patients After Total Gastrectomy

sarcopenia is defined as low skeletal muscle mass plus low muscle strength or low physical ability.

Chemotherapy toxicity will be monitored at end of each cycle during chemotherapy by investigators, and graded according to the CTCAE, version 5.0.

Quality of life assessed by EORTC QLQ-C30

Zhongda Hospital

Shandong Provincial Hospital

Hebei Medical University Fourth Hospital

Zunyi Medical College

Xinqiao Hospital of Chongqing

Jinling Hospital, China

Prof.

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Colorectal Neoplasms

Carcinoma

Carcinoma, Hepatocellular

Cholangiocarcinoma

Malnutrition

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Bile Duct Cancer

oral nutritional supplement rich in eicosapentanoic acid

Matthias Pirlich, MD

Malnutrition is a frequent symptom of various malignant diseases and is frequently observed in patients with gastrointestinal tumors. Eicosapentanoic acid (EPA) has been introduced as specific and anticatabolic acting substrate in cancer patients. Only few randomized trials are available which investigated the effect of EPA in form of an EPA-enriched, protein- and energy-dense oral nutritional supplement mostly in patients with pancreatic carcinoma.

Therefore, the effect of an EPA-rich oral nutritional supplement for two months on functional state and quality of life in patients with other gastroenterological tumors and weight loss is investigated in this randomized prospective trial.

Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors

Pilot Study: Randomized Controlled Trial on the Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors

Pfrimmer Nutricia GmbH, Erlangen , Germany

Charite University, Berlin, Germany

Dr. Matthias Pirlich

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Inflammatory Bowel Diseases

Peptic Ulcer

Ulcer

Duodenal Neoplasms

Gastroenteritis

Duodenal Diseases

Pancreatic Cancer

Biliary Tract Cancer

oral administration of Encover 2 package for day starting at the time of discharge (200ml/package x 2, total 400Kcal/day) total 87 patients

oral nutritional supplement

Hyuk-Joon Lee, MD, PhD

Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption function, and/or metabolic changes after surgery. The postoperative malnutrition is associated with low quality of life and seems to be related long-term nutritional status. This study is a multicenter, open-labeled prospective randomized clinical trial to examine the effect of postoperative oral nutritional supplements (ONS) after major gastrointestinal surgery by comparing the change of body weight and other nutritional parameters between the experiment group that is supplied with ONS and the control group without ONS.

Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery

Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Oral Nutritional Supplements on Patients Undergoing Haematopoietic Stem Cell Transplantation	NCT05460013	Haematological ...	Traditional Con... Oral Nutritiona...	18 Years - 75 Years	RenJi Hospital
Administration of ONS Based on Purple Sweet Potato in Head and Neck Cancer Patients With Radiotherapy	NCT05740878	Oral Nutritiona...	immunonutrients... standard oral n...	18 Years - 80 Years	University of Brawijaya
ONS in Gastric Cancer After Total Gastrectomy	NCT05823272	Gastric Cancer	ONS	18 Years - 80 Years	Jinling Hospital, China
Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors	NCT00168987	Colorectal Neop... Hepatocellular ... Cholangiocarcin...	oral nutritiona...	18 Years -	Charite University, Berlin, Germany
Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery	NCT01838109	Gastric Cancer Colon Cancer Pancreatic Canc... Duodenal Cancer Biliary Cancer Peptic Ulcer Inflammatory Bo...	oral nutritiona...	20 Years - 80 Years	Seoul National University Hospital
Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors	NCT00168987	Colorectal Neop... Hepatocellular ... Cholangiocarcin...	oral nutritiona...	18 Years -	Charite University, Berlin, Germany
ONS in Gastric Cancer After Total Gastrectomy	NCT05823272	Gastric Cancer	ONS	18 Years - 80 Years	Jinling Hospital, China
ONS in Gastric Cancer After Total Gastrectomy	NCT05823272	Gastric Cancer	ONS	18 Years - 80 Years	Jinling Hospital, China

Spots Global Cancer Trial Database for oral nutritional supplement