Nutritional and Metabolic Diseases

All Conditions

Neoplasms

Digestive System Diseases

Malnutrition

Gastrointestinal Neoplasms

Digestive System Neoplasms

Nutrition Disorders

Gastrointestinal Diseases

Home Enteral Nutrition was planned to cover the basal energy requirement calculated with Harris Benedict Formula, it was administrated preferentially during nocturnal hours as an integration of oral diet.

Enteral Nutrition included any standard polymeric formula providing 1-1.5 Kcal/mL with carbohydrates 50%-60%, lipids 25%-35% and protein 12%-20%.

Home Enteral Nutrition can be withdrawn in the treated group, after 2 months from discharge, whenever a weight gain ≥ 5% is reported, and oral alimentation is regular and adequate.

Enteral nutrition

Specific nutritional advices including total energy and protein requirements were provided to patients and oral high-calorie supplements were prescribed whenever necessary.

Home Enteral Nutrition can be started in patients of the control group, not before two months from discharge, if a further weight loss ≥ than 5% is reported.

Dietary counseling

Cecilia Gavazzi, MD

Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized, clinical trial.

The aim of this study is to evaluate the efficacy of home enteral nutrition on the nutritional status, the quality of life and tolerance to chemotherapy, in malnourished patients who undergo major gastrointestinal surgery for malignancy (oesophagus, stomach, pancreas, biliary tract). Patients were randomized to receive either home enteral nutrition (HEN, treatment group) or nutritional counselling (control group).

Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer: A Multicenter Randomized Clinical Trial

Evaluated by weight change after discharge

Evaluated at hospital admission and two months after discharge by the self-administrated Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire

Evaluated by the ratio chemotherapy planned / chemotherapy administered

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Symptoms and General Pathology

Behaviors and Mental Disorders

Colorectal Neoplasms

Body Weight

Weight Loss

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Central Nervous System Stimulants

Megestrol

Megestrol Acetate

Patients receive dietary advice at an individual level and are offered contact with clinical dietitian every second week if necessary.

Dietary advice based on individual requirement and symptom burden. Dietary intervention may be dietary advice, energy rich foods and drinks, oral nutritional supplements, appetite stimulation with Megestrol Acetate, enteral or parenteral nutrition.

Individual dietary counseling.

Lene Thoresen, MSc

The purpose of this randomised intervention study is to investigate to what degree patients with colorectal cancer benefit of dietary counselling regarding nutritional status, oncologic treatment and quality of life.

Can Malnutrition be Prevented in Patient With Colorectal Cancer Stage Dukes D?

A Randomised Study of Dietary Counseling for Patients With Colorectal Cancer.

St. Olavs Hospital

Norwegian University of Science and Technology

Heart and Blood Diseases

Heart Failure

Heart Diseases

Monthly visits with the cardiology team and a booklet about coping with heart failure.

Usual Care

Exercise Training

Food log, booklet, and a cookbook to help decrease the salt content in your diet.

Dietary Counseling

Karen Basen-Engquist, PhD

The goal of this behavioral research study is to learn if education and training about exercise can help to change the lifestyle of cancer survivors with symptoms of heart failure.

Baseline Study Procedures:

If you agree to take part in the pretest portion of this study, your cardiology team will look at a number of tests performed on your heart as part of your usual care, as well as your complete medical history, to find out if you are eligible to take part in this study.

If you are found to be eligible to take part in this study, you will be scheduled for a visit to the Behavioral Research and Treatment Center (BRTC) at MD Anderson.

Before your first visit to the BRTC, you will complete the following tasks at home:

-You will wear an accelerometer to measure your physical activity for 1 week. An accelerometer is a small device that you wear on your waist during the day. It records how active you are. You will bring the accelerometer with you when you come for your first visit in the BRTC.

During your first visit to the BRTC, the following tests and procedures will be performed:

* You will have an electrocardiogram (ECG), which takes about 10 minutes. An ECG is a test used to measure the electrical activity of the heart.
* You will have your blood pressure and heart rate measured.
* You will complete questionnaires about your symptoms, quality-of-life, psychological distress, and exercise. These should take about 60 minutes to complete.
* You will complete 2 reaction time tasks on the computer. In one task, you will press a button on the keyboard to indicate the color of a word on the screen. In the other task, the computer will present a statement and you will press a button on the keyboard to indicate whether you think it is true or false. The statements are all opinions. It is not a test of knowledge. The 2 reaction time tasks together should take a total of about 10 minutes.
* You will do an exercise test on the stationary bicycle. You will ride on the stationary bicycle for about 10-15 minutes while your heart rate, blood pressure, and breathing are recorded by certified exercise specialists. While you are pedaling, the difficulty level will be changed by the study staff. First, you will pedal at a low difficulty level. After a 5-minute warm up period, the difficulty level will be slowly increased for about 3-5 minutes until you reach the point you cannot continue at that difficulty level. After that point, the difficulty level will be lowered for about 5 minutes to allow you to cool down. You can stop the test at any time.
* Then, you will repeat completing the exercise questionnaires and the reaction time tasks on the computer, which should take about another 10 minutes.

Study Groups:

After the above test and procedures, you will be randomly assigned (as in the flip of a coin) to be in 1 of 2 groups. You will have an equal chance of being in either group.

If you are in Group 1, you will receive the usual care as provided by the cardiology service, and a booklet about coping with heart failure. Dietary counseling will be provided once a month to encourage you to follow to a low sodium diet, with the goal of limiting sodium to 2 grams per day. The dietary counseling will include education about the effects of sodium for patients with heart failure, sources of sodium in the diet, reading food labels, identifying low-sodium alternatives to high-sodium foods, and using other types of flavorings rather than salt and other high-sodium condiments. You will be given the booklet How to Follow a Low Sodium Diet from the Heart Failure Society of America (appendix S and a copy of the American Heart Association Low-Salt Cookbook, 3rd edition. If you are a tobacco user or have recently quit, you will be referred to the MD Anderson Tobacco Treatment program. At the end of 16 weeks, after you have completed your 4 month visit in the BRTC, you will be offered exercise training described below. If you want to participate in the exercise training, you may do so at that time.

If you are in Group 2, you will receive all the components of usual care, plus exercise training.

Exercise Training:

If you are in Group 2, you will visit the BRTC 3 times a week for exercise training. For the first 12 sessions, you will exercise on a stationary bicycle while your heart rate, ECG, and blood pressure are recorded.

After the cardiologist finds that you are able to exercise safely, you will use part of the exercise session to do exercise without having your heart rate, ECG, and blood pressure recorded. Your exercise sessions at the BRTC will be supervised by a study staff member at all times. After you have exercised safely for at least 4 weeks, you will begin at-home exercise program, which will be a series of exercises developed individually for you, in addition to the supervised exercise sessions in the BRTC. You will be given an exercise log to describe your at-home exercise, and any problems or symptoms you experience during or after the at-home exercise sessions.

The visits to the BRTC for exercise training will last about 1 hour. You will come to the BRTC for these visits 3 times a week for 16 weeks.

If you are in Group 1, you have the option of choosing the exercise training described above or a 12-week home-based exercise training program that you will start after your 4 - month visit to the BRTC. You will be scheduled for an in-person exercise session with the exercise physiologist at the BRTC at MD Anderson. During this visit, you will receive instructions on how to complete your exercise sessions safely and effectively at home. This visit will take about 1 hour to complete. You will be provided with an exercise recommendation that will help you work up to 30 minutes of exercise, at least 3 times a week.

The exercise physiologist will call you once a week for 12 weeks to check on your progress and answer any questions you may have about your exercise program. You will also have the opportunity to come back to MD Anderson up to 1 time a week if you would like help from the exercise physiologist.

You will be given a pedometer to wear. A pedometer is a small device (about the size of a deck of cards) that is worn on the belt and measures the number of steps you take each day. You will record the number of steps and minutes of exercise for each day on an exercise log sheet.

At Weeks 4 and 8 (+/- 7 days), you will have a telephone interview about any side effects you may be having and how well you are able to function in daily activities.

You will also be counseled on limiting how much sodium you consume. The dietary counseling will include education about the effects of sodium on patients with heart failure, sources of sodium in the diet, reading food labels, identifying low-sodium alternatives to high-sodium foods, and using other types of flavorings rather than salt and other high-sodium condiments.

These calls should take about 45 minutes.

Follow-Up Visits:

If you are in either Group 1 or Group 2, you will have an appointment with the MD Anderson cardiology team 4 months from the baseline assessment. At this visit you will be asked about your symptoms. Blood (about 1 teaspoon) will be drawn to measure biomarkers at baseline and at the 4 month visit. Biomarkers are chemical "markers" in the blood that may be related to your heart failure.

If you are in Group 1 or Group 2, you will have a follow-up visit in the BRTC about 16-18 weeks after your baseline visit.

Ten (10) days before this visit, you will receive a new accelerometer in the mail. You will be called and reminded to wear the accelerometer. You will wear the accelerometer for 7 days and then bring it to the last visit to the BRTC.

At your last follow up visit to the BRTC, the following tests and procedures will be performed:

* You will complete questionnaires about your symptoms, quality of life, psychological distress, and exercise.
* You will complete 2 reaction time tasks on the computer.
* After these questionnaires and reaction tests, you will have an ECG and your blood pressure and heart rate will be measured.
* You will have an echocardiogram.
* You will then do an exercise test on the stationary bicycle.
* Then you will repeat the exercise questionnaires and the reaction time tasks on the computer.
* You will also be asked to take part in an interview about what you thought of the exercise program and the tasks you performed at home. This interview should take about 15 minutes.

After your 16-week visit, information about your cardiac tests, health problems, and hospitalizations will be collected from your medical record.

Participants in the waiting list group who choose to participate in the exercise program after their 16 week assessment will complete questionnaires once a month to measure symptoms. After 4 months of exercise (3 months for home-based) they will repeat all the follow-up tests described above.

This is an investigational study.

Up to 80 participants will be take part in this study. All will be enrolled at MD Anderson.

Lifestyle Intervention for Heart Failure

Take Heart: Exercise & Diet Intervention for Heart Failure in Cancer Survivors

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Inflammation

Breast Neoplasms

Mastitis

Weight Gain

Gestational Weight Gain

Breast Diseases

Skin Diseases

Body Weight Changes

Intensive dietary counseling and fruit and vegetable box delivery.

Control condition of information on healthy eating during breastfeeding

The counseling approach will employ strategies shown to be successful in previous and ongoing dietary modification studies including supportive and motivational interviewing techniques. Each woman in the diet intervention group will be assigned a trained nutrition coach/counselor. Counselors will focus on helping participants identify and address barriers to achieving the goal of consuming at least 8 to 10 servings of nutrient dense fruits and vegetables each day (e.g., modifying recipes and food preparation). Participants will also receive weekly boxes of fruits and vegetables .

Kathleen Arcaro, PhD

Susan Sturgeon, DrPH

Lindiwe Sibeko, PhD

Mechanistic data show that compounds in fruits and vegetables have anti-inflammatory and anti-carcinogenic properties that can reduce breast cancer risk. However, observational and interventional studies have provided mixed results, and a recent report by the American Institute for Cancer Research (AICR) concludes that the data are insufficient but suggestive that non-starchy vegetables and foods containing carotenoids reduce risk. Measurement error, relatively low levels of carotenoid-rich fruit and vegetable intake in the study populations, emphasis on diet in later adulthood, and confounding factors likely contribute to the weak associations. Therefore, the investigators will conduct a randomized diet intervention trial in young women to assess the extent to which at least 8 to 10 daily servings of deeply pigmented and nutrient dense fruits and vegetables reduces biomarkers of breast cancer risk. The intervention is focused on breastfeeding women because: 1) pregnancy and lactation are normal early life course events; 2) the risk of pregnancy-associated breast cancer (PABC) is increased for up to 10 years postpartum; 3) a dietary intervention to reverse the detrimental molecular changes associated with puberty and pregnancy is more likely to be successful in younger than in older women;4) a diet rich in fruits and vegetables is hypothesized to reduce the inflammation during lactation/weaning and lower PABC risk; 5) postpartum lactating women may be a highly motivated population; and 6) breastmilk provides access to the breast microenvironment and breast epithelial cells to non-invasively assess the diet intervention directly in the breast. Four hundred nursing mothers will be randomly assigned to either the intervention arm, in which they are asked to increase fruit and vegetable intake to at least 8 to 10 daily servings for one year, or to a control condition in which participants receive a dietary guideline for breastfeeding mothers. Women in the intervention arm will receive counseling and boxes of fruits and vegetables for the first 20 weeks, after which they will continue to receive counseling. Changes in DNA methylation and cytokine profiles in breastmilk will be evaluated. Maternal weight and body fat distribution, and infant growth will be monitored. These results will greatly expand our knowledge of how diet alters molecular pathways in a specific organ, ultimately contributing to both breast cancer etiology and prevention.

Overview of home visits and activities completed by all participants

Visit 1 Introductory Visit (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 5 weeks postpartum

* Informed Consent document administered.
* Public Data Sharing Informed Consent document administered.
* Three questionnaires: New Moms Health, Physical Activity, and Breastfeeding Practices
* Maternal height, weight, and waist circumference measured.
* Instructions provided for future collection of biospecimens.
* Complete one 24-Hour Dietary Recall
* Instructions provided for two additional 24-Hour Dietary Recalls.

Visit 2 Sample Collection 1 (1.5 hours) Occurs at 6 weeks postpartum

* Provide bilateral breast milk samples and completed questionnaire.
* Provide infant stool sample and completed questionnaire.
* Two questionnaires: Infant Feeding, and Medication \& Supplement
* Infant length and weight measured.
* Maternal and infant skin carotenoids measured.
* Nutrition education provided.
* Optional collection of maternal stool sample and completed questionnaire.

Visit 3 Sample Collection 2 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 16 weeks postpartum

* Provide bilateral breast milk samples and completed questionnaire.
* Provide infant stool sample and completed questionnaire.
* Three questionnaires: Physical Activity, Infant Feeding, and Medication \& Supplement
* Infant length and weight measured.
* Maternal weight and waist circumference measured.
* Maternal and infant skin carotenoids measured.

Visit 4 Sample Collection 3 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 26 weeks postpartum

* Provide bilateral breast milk samples and completed questionnaire.
* Provide infant stool sample and completed questionnaire.
* Three questionnaires: Physical Activity, Infant Feeding, and Medication \& Supplement.
* Infant length and weight measured.
* Maternal weight and waist circumference measured.
* Maternal and infant skin carotenoids measured.
* Optional collection of maternal stool samples and completed questionnaire.

Visit 5 Sample Collection 4 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 58 weeks postpartum

* Provide bilateral breast milk samples and completed questionnaire.
* Provide infant stool sample and completed questionnaire.
* Four questionnaires: Physical Activity, Infant Feeding, Medication and Supplement, and Breast Health
* Infant length and weight measured.
* Maternal weight and waist circumference measured.
* Maternal and infant skin carotenoids measured.
* Optional collection of maternal stool samples and completed questionnaire.

Annual Follow-up Visit (Maximum of 2) (1 hour) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at one-year intervals after Visit 5

* Three questionnaires: Physical Activity, Breast Health, Young Child Feeding
* Infant height and weight measured.
* Maternal weight and waist circumference measured.
* Maternal and infant skin carotenoids measured.

Monthly Inquiry (1 - 2 minutes) Occurs monthly until no longer breastfeeding

• Complete the Breast Feeding Update Questionnaire online via a survey sent through REDCap, or through a phone call.

Key laboratory analyses will conducted by laboratories blinded to intervention arm.

Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk

Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk: Effects on Breast Cell DNA Methylation, Breast Inflammation,and Weight

There is no plan to make IPD available to other researchers.

% methylation in 300,000 CpG sites in DNA from sloughed breast epithelial cells from milk

Adiponectin, CRP, IFN-y, IL1-beta, Leptin, IL-6, IL-8, TNF-alpha, b-FGF, FLT-1, PLGF, VegF-D

National Cancer Institute (NCI)

University of Massachusetts, Amherst

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer	NCT02664974	Malnutrition Gastrointestina...	Enteral nutriti... Dietary counsel...	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Can Malnutrition be Prevented in Patient With Colorectal Cancer Stage Dukes D?	NCT00846313	Colorectal Neop...	Individual diet...	18 Years -	Norwegian University of Science and Technology
Lifestyle Intervention for Heart Failure	NCT00633633	Heart Failure	Usual Care Exercise Traini... Dietary Counsel...	18 Years -	M.D. Anderson Cancer Center
Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk	NCT04374747	Breast Cancer F... Inflammation Postpartum Weig... Diet, Healthy Risk Reduction	Dietary Counsel...	18 Years -	University of Massachusetts, Amherst
Juice Plus+ and Juice Plus+ Complete in Ovarian Cancer	NCT01439659	Ovarian Cancer	Nutritional Cou... Daily Supplemen...	21 Years -	M.D. Anderson Cancer Center
Can Malnutrition be Prevented in Patient With Colorectal Cancer Stage Dukes D?	NCT00846313	Colorectal Neop...	Individual diet...	18 Years -	Norwegian University of Science and Technology

Spots Global Cancer Trial Database for dietary counseling