Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.

carbohydrate loading, immunonutrition (formulated liquid diet), protein supplement

PreCovery is a carbohydrate loading nutritional supplement, INergy FLD is an immunonutrition formulated liquid diet, and ISOlution is a protein supplement.

Nutritional Supplements

Placebo

This is a single-center randomized, placebo-controlled, double-blind feasibility study comparing the intervention of perioperative nutritional supplements (immunomodulation, carbohydrate loading, and protein isolate) with an identical placebo for each solution in patients with gastrointestinal cancer undergoing surgery. Eligible and consenting patients will be randomly allocated to receive the intervention or placebo in a 1:1 ratio.

This study will assess the feasibility of a large, multi-centre trial by establishing the feasibility of randomization to intervention or placebo. This study will be conducted at the Juravinski Hospital and will enroll 100 patients over 18 months.

The study intervention includes three perioperative nutritional supplements: (1) a protein supplement administered 3 times a day for 30 days before surgery, (2) a sugar-based supplement administered the day prior to and the day of surgery, and (3) a formulated liquid diet containing arginine, RNA, proteins and omega-6 fatty acids (referred to as immunonutrition for the purposes of this study) administered for 5 days prior to and 5 days after surgery.

The primary outcome for each eligible patient is defined as being randomized to intervention or placebo. The criteria for success of this study is defined as the proportion of eligible patients randomized as ≥ 60%. If the estimated proportion is \<40%, the trial will be considered not feasible. If the proportion is between 40%-59%, the trial will be considered feasible with modifications to improve enrolment. Other secondary objectives include compliance with study intervention, estimating differences in postoperative complications, length of hospital stay, and quality of life between groups.

PeRioperative Optimization With Nutritional Supplements for Patients Undergoing GastRointEStinal Surgery for Cancer

PeRioperative Optimization With Nutritional Supplements in Patients Undergoing GastRointEStinal Surgery for Cancer (PROGRESS): A Randomized Placebo Controlled Feasibility Study.

Feasibility of this study will be determined by the number of eligible patients randomized to intervention or placebo.

Compliance will be defined as intake of at least 70% of study intervention regimen.

Occurrence of any postoperative complication (major or minor) from surgery following each patient's hospital stay and up to 90 days from the initial operation. Occurrence of any postoperative infections will also be calculated.

At 90 days from the index operation will be determined for each patient. This index can be calculated for each patient using the online calculator www.assessurgery.com25 following the grading of each postoperative complication according to Clavien-Dindo.

The global health related QoL at baseline, 1 and 3 months following randomization measured using the EORTC-QLQ-C instrument.

The global health related QoL at baseline, 1 and 3 months following randomization measured using the FACT-G scale.

Hamilton Health Sciences Corporation

Assistant Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

For 6 months control group receives dietary counseling.

2 capsules (Juice Plus+) twice a day (morning and evening) plus Juice Plus+ Complete drink each evening for 6 months.

Initial interview and subsequent telephone contact once per week for two months, once every other week for the following two months, and once per month for the remaining two months.

Nutritional Counseling

Two capsules daily in the morning and two capsules daily in the evening of Juice Plus+ in addition to regular meal. Also a beverage, Juice Plus+ Complete (a powder mixture to be added to one cup of fluid) daily in the evening.

Daily Supplements

Beverly C. Handy, MD

The goal of this clinical research study is to see if ovarian cancer patients who add Juice PLus+ and Juice Plus+ Complete to their diets have better outcomes when compared to ovarian cancer patients who receive only dietary counseling alone.

Before starting the study, patients will have a dietary pattern evaluation, physical exam, blood test, height, weight, hip, wrist, mid-arm and waist circumference measurements.

Researchers will compare changes in weight, waist, hip, mid-arm and wrist size, and changes in the amount of vitamins, iron, and nutrients in the blood. Researchers will also measure the levels of some proteins that can be linked to ovarian tumors.

Patients will be randomly picked (as in the toss of a coin) to be in one of two groups. One group will receive free of charge nutritional counseling for 6 months, while the second group will receive free of charge daily supplements . These supplements will be made up of a combination from fruits and vegetables (Juice Plus+). Patients will be asked to take two capsules (Juice Plus+) in the morning, and two capsules (Juice Plus+) along with a drink containing vitamins and minerals (Juice Plus+ Complete) in the evening for 6 months.

All patients will have their eating patterns monitored for six months. Patients will come to the clinic at least every three months as part of their normal treatment schedule. Each visit will take 3 hours and will include a physical exam, blood tests, and anthropometric measurements (height, weight, waist, hip, mid-arm, and wrist circumferences). At some visits, dietary and quality of life assessments will also be done.

With the exception of the first interview, nutritional counseling will be mostly done by a 30 to 60 minute telephone call once a week for two months. Counseling will also be done once every other week for two months and then once a month for two months.

Participation in this study will be stopped if patients have to start being fed by vein, patients get pregnant or begin breast feeding, patients have bowel obstruction, patients are diagnosed with a condition requiring a restricted diet, patients begin medication that is incompatible with a high fiber diet, or patients have severe side effects.

This is an investigational study. A total of 50 patients will take part in this study.

Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer

A Randomized Phase II Study of the Nutritional Supplements Juice Plus + and Juice Plus + Complete in Ovarian Cancer Patients

Measurements of serum lipid peroxide and serum carotenoid levels obtained at baseline and at least every 3 months for total of 6 months; 3 measurements per participant used to assess changes in the lipid peroxide and serum carotenoid levels - baseline measurement during and after treatment. Outcome evaluated using repeated measures ANOVA design with 2 groups and 3 time points.

Natural Alternatives International

M.D. Anderson Cancer Center

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Neoplasm Metastasis

Malnutrition

Abdominal Neoplasms

Nutrition Disorders

Patients are asked to drink two 200ml bottles of nutritional supplement daily

Patients are asked to keep on to their normal diet. No supplementation is introduced

Patients are asked to drink two 200ml bottles of nutritional supplement daily for 14 days before surgery

Nutritional supplements

Paweł Kabata, MD

Tomasz Jastrzębski, Prof

Michał Kąkol, MD

Karolina Król, MSc

Tomasz Jastrzębski, Prof.

The aim of the study was to assess the effect of nutritional supplementation on nutritional status and postoperational complications in cancer patients with no clinical signs of malnutrition

In previous psychological studies our team found high level psychological stress in over 60% of cancer patients. This may cause numerous problems including anorexia, which together with biological disturbances can initiate cancer related catabolism even when it can not yet be seen. In this study we want to answer the question if oral nutritional supplementation can help the patient overcome the catabolism in its initial phase and improve nutritional status, which would result in reduced number of postoperational complications

Nutritional Supplementation in Patients With no Signs of Malnutrition

The Effect of Nutritional Supplementation in Cancer Patients With no Clinical Signs of Malnutrition

The aim of the study was to assess if nutritional supplementation improves nutritional status of patients with no clinical signs of malnutrition. Nutritional status improvement will be assessed by change in anthropometric (body weight (kg)) and laboratory (albumin, total protein, transferrin level, total lymphocyte count) parameters.

To assess if improvement of nutritional status is connected with reduced number of postoperative complications.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PeRioperative Optimization With Nutritional Supplements for Patients Undergoing GastRointEStinal Surgery for Cancer	NCT03445260	Gastrointestina...	Nutritional Sup... Placebo	18 Years -	Hamilton Health Sciences Corporation
Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer	NCT01439659	Ovarian Cancer	Nutritional Cou... Daily Supplemen...	21 Years -	M.D. Anderson Cancer Center
Nutritional Supplementation in Patients With no Signs of Malnutrition	NCT01894828	Primary Neoplas... Secondary Neopl... Abdominal Neopl...	Nutritional sup...	18 Years -	MedSource Polska

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