Neoplasms

Symptoms and General Pathology

All Conditions

Wounds and Injuries

Neoplasm Metastasis

Hyperthermia

Fever

Neoplastic Processes

All Drugs and Chemicals

Immunomodulating Agents

Immunologic Factors

Perioperative immunonutrition will commence 5-7 days prior to surgery, and will continue for 5-7 days post-surgery, as soon as the patient is able to consume full feeds as instructed by his/her primary physician.

The recommended dose for IMPACT immunotherapy is one packet, to be taken three times a day.

Standard nutritional supplementation will commence 5-7 days prior to surgery, and will continue for 5-7 days post-surgery, as soon as the patient is able to consume full feeds as instructed by his/her primary physician.

Powdered formula that is pre-packaged in individual packets which the patients will be instructed to mix with water before consumption.

IMPACT immunotherapy

Liquid milk formula available over the counter

ENSURE

Melissa Teo, MD

Patients with peritoneal disease commonly present with symptoms of abdominal distension and subacute intestinal obstruction. This results in poor oral intake leading to these patients often presenting in a malnourished state.

CRS and HIPEC can potential provide improve survival for these patients, however can be a hazardous procedure, involving multi-organ resections. The risk is especially high in poorly nourished patients.

The study investigators hypothesize that perioperative immunonutrition can reduce wound infections and length of hospital stay, and improve perioperative outcomes. To the investigators' knowledge, it has not been evaluated in patients undergoing CRS and HIPEC.

The investigators and the clinical team which manages the patient, will be blinded.

Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

Perioperative Immunonutrition for Patients Undergoing Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy

National Cancer Centre, Singapore

Skin and Connective Tissue Diseases

Breast Neoplasms

Body Weight

Body Weight Changes

Breast Diseases

Skin Diseases

Medical supplement and nutritional advise

Ensure 6 scoops dietary supplement powder in 250 ml of water, 2 drinks per days for 12 weeks.

Ensure

Meitinarth Juntong

Piyawan Tienchaiananda

The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard AC regimen).

The main question is

• the change of weight (%) before and after complete treatment of breast cancer therapy.

Participants will be randomized into 2 group

* intervention group - receive medical supplement daily during chemotherapy treatment.
* control group - Nutritional advise during chemotherapy treatment.

1. The rational is to prove the hypothesis is that, the effect of medical supplement with nutritional advise can prevent the reduction of body weight, malnutrition and treatment complication, which eventually to improve of the quality of life.
2. Primary endpoint of the study is to compare the effect of medical supplement on percent weight change in early breast cancer who received chemotherapy in Rajavithi hospital. Secondary endpoints are nutritional status (PG-SGA), quality of life.
3. Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 40 patients.
4. Randomization into 2 groups. Intervention arm : receive medical supplement daily (1 drink = 6 scoops in 250 ml water, 2 drinks/day) with nutritional advise. Control arm : nutritional advise only. Duration of treatment is 12 weeks
5. Enrollment and data monitoring is assessed by the staffs of oncology department in Rajavithi hospital and the data will be recorded in computer based information system.
6. Data assessment on week 0,6,12 during chemotherapy treatment.
7. Data analyzed by descriptive statistics to characterize patients at entry. We did the efficacy analyses with intention to treat population
8. We did analyses with R version 3.3.0.

Percent Weight Change in the Medical Supplement Group of Early Breast Cancer

Effects of Body Weight Change in the Medical Supplement Group in Patients With Early Breast Cancer During Chemotherapy: a Randomized, Controlled Trial

Due to this study is performed on single institution. The study protocol will be provided later on published article.

The change of body weight (%) before and after chemotherapy treatment

The change of Global Quality of life before and after chemotherapy treatment score

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC	NCT03430128	Peritoneal Meta...	IMPACT immunoth... ENSURE	21 Years -	National Cancer Centre, Singapore
Percent Weight Change in the Medical Supplement Group of Early Breast Cancer	NCT06311357	Early Stage Bre...	Ensure	18 Years - 80 Years	Rajavithi Hospital

Spots Global Cancer Trial Database for ensure

Every month we try and update this database with for ensure 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 ensure

Every month we try and update this database with for ensure 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 ensure 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.