Behaviors and Mental Disorders

All Conditions

Quality of Life

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

Patients presenting to the Arizona Center for Advanced Medicine for the treatment of cancer using Insulin Potentiation Low Dose Chemotherapy and Nutrition Therapy

The measurement of Quality of Life in patients who choose to use Insulin Potentiation Low Dose Therapy and Nutritional Therapy in the treatment of cancer

IPTLD and nutrition therapy

Martha M Grout, MD, MD(H)

A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer.

A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer

The IPTLD QoL Broad Study A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer

Improvement in Quality of Life using Insulin Potentiation Low Dose Chemotherapy and Nutrition Therapy for the Treatment of Cancer, as measured by MD Anderson's MDASI questionnaires

Best Answer for Cancer Foundation

Neoplasms

Head and Neck Neoplasms

Patients will receive the symbiotic product LactoFos twice a day during seven days after surgical treatment. The intervention consists of giving twice a day a sachet of 6g of symbiotic diluted in 20mL of water via nasoenteric tube for seven days, totaling the administration of 14 sachets per intervention.

Patients will receive 6g of maltodextrin twice a day during seven days after surgical treatment.

Intervention will consist of the adminitration of symbiotic product twice a day during seven days after surgical treatment

Symbiotic

Intervention will consist of the adminitration of placebo product twice a day during seven days after surgical treatment

Maltodextrin

Priscilla C Lages, bachelor

The purpose of this study is to determine whether the symbiotic use in patients with head and neck cancer impact on intestinal function after surgical treatment.

The study will be conducted offering the patients symbiotic product twice a day for seven days after the surgical treatment. Patients will be monitored for the number of stools, stools consistency, abdominal pain and gas overproduction.

Impact of Symbiotic Administration on Intestinal Function of Head and Neck Patients Surgically Treated

Intestinal Function of Patients With Uper Air and Digestive Neoplasia Submitted to Surgical Treatment: Symbiotic Use Impact

The intestinal permeability using serum DAO enzyme concentration (ng/mL) was determined by sandwich enzyme-linked immunosorbent assay (ELISA) kit (SEA656Hu), according to Cloud-Clone Corporation® (Huston, TX) specifications.

Federal University of Minas Gerais

Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days.

Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days.

Total

Age, Categorical

Sex: Female, Male

Nourished

Malnourished

Nutritional status

Dr. Maria Isabel Correia

Serum DAO Enzyme Concentration

Infection Rate

Patients will receive twice a day the symbiotic product during seven days after surgical treatment

LactoFos: Patients will receive the product twice a day during seven days after surgical treatment

Patients will receive twice a day the placebo product during seven days after surgical treatment

Maltodextrin: Patients will receive maltodextrin twice a day during seven days after surgical treatment

Overall Study

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Rare Diseases

Syndrome

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hereditary Breast and Ovarian Cancer Syndrome

Breast Neoplasms

Endocrine Gland Neoplasms

Neoplastic Syndromes, Hereditary

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

Genetic Diseases, Inborn

Breast Diseases

Skin Diseases

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Central Nervous System Stimulants

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

Micronutrients

Platelet Aggregation Inhibitors

Other Dietary Supplements

Caffeine

Curcumin

Selenium

Trace Elements

Antioxidants

Zinc

Carotenoids

Resveratrol

Phytoestrogens

Lycopene

Genistein

Indole-3-carbinol

Protective Agents

Indole

The patient will get a nutritional personalized treatment with the following characteristics: hypocaloric diet, rich in micronutrients related with DNA reparation and polyphenols, with the next distribution: 45% carbohydrates, 30% lipids, 25% protein, \<10% saturated fats, \>10% unsaturated fats, based on the recommendations of the American Institute for Cancer Research (AICR).

Antioxidant therapy based in the following dietary components: Zinc, Selenium, Magnesium, carotenoids, indole-3-carbinol, curcumin, epigalactocatechin, caffeine, resveratrol, lycopene, genistein, phytoestrogens

Antioxidant therapy

María Fernanda Díaz Yáñez, BSc

Martha Fernanda Medero López, BSc

Juan Antonio Pineda Juárez, PhD

Martha Orozco Quiyono, MSc

Mónica Escamilla Tilch, PhD

Breast and Ovarian Cancer Syndrome (HBOC) is characterized by mutations in tumor suppressor genes such as BRCA1 and BRCA2, which increase the carrier's risk of developing breast and ovarian cancer, especially before 40. In this pathology the DNA damage is increased because there is a state of chronic inflammation, plus the antineoplastic treatments and changes in body composition result in oxidative stress. The inductions of epigenetic changes by a nutritional intervention with an specific distribution of macronutrients, micronutrients and polyphenols, not only ensures an optimal nutritional status, but also shows a decrease in oxidative stress, and therefore in DNA damage. The aim of this study is to assess if the DNA damage in patients with HBOC decreases after the nutritional intervention.

Breast and Ovarian Cancer Syndrome (HBOC) is a genetic disease characterized by mutations in tumor suppressor genes such as BRCA1 and BRCA2, elevation of Reactive Oxygen Species (ROS), inflammation and DNA damage; all this as a result of the pathology itself. Antineoplastic treatments and changes in body composition such as malnutrition, cachexia and obesity lead to an increase of the inflammatory state. The induction of epigenetic changes by a nutritional intervention suggests that an hypo caloric diet, complex carbohydrates, polyunsaturated fatty acids, some amino acids, and some vitamins, minerals and polyphenols as well, can reduce DNA damage because of the interaction between mechanisms related with DNA stability and reparation, cellular replication, induction of apoptosis, and antioxidant systems. Previous studies report that using polyphenols supplements can reduce de DNA damage, but when the administration is only through food there's no benefit at all. So the aim of this study is to assess if the use of different micronutrients and polyphenols in conjoint can make synergism and reduce de DNA damage without the need of supplements.

Nutritional Intervention and DNA Damage of Patients With HBOC

Effects of a Nutritional Intervention in DNA Damage of Patients With Hereditary Breast and Ovarian Cancer Syndrome

Will individual participant data be available (including data dictionaries)? No

What data in particular will be shared? Not available

What other documents will be available? Study Protocol, Statistical will be available? Analysis Plan, Informed Consent Form, Clinical Study Report

A blood sample will be taken to assess DNA damage (ELISA) by 8-hydroxy-2-deoxyguanosine (8-OHdG), a modified nitrogen base indicating oxidative damage to DNA, before and after nutritional intervention.

A bioelectrical impedance analysis will be used to assess the body composition through the reactance and resistance values (both measured in Ohm), before and after nutritional intervention.

A hand grip dynamometer will be used to assess the muscular strength in kg, both before and after the nutritional intervention.

A 24-hour recalls will be performed to evaluate amount of energy (measured in kilocalories), before and after the nutritional intervention.

A 24-hour recalls will be performed to evaluate amount of carbohydrate, protein and fat (all measured in percentage and grams), before and after the nutritional intervention.

A 24-hour recalls will be performed to evaluate amount of vitamin E, calcium, zinc and magnesium (all measured in milligrams), before and after the nutritional intervention.

A 24-hour recalls will be performed to evaluate amount of folate, vitamin A and D, selenium, lycopene, and flavones (all measured in micrograms), before and after the nutritional intervention.

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Researcher - Research Coordination

Digestive System Diseases

Esophageal Neoplasms

Esophageal Cancer

12 week multi-disciplinary intervention prescribing exercise, individual dietary counselling and education sessions.

The RESTORE trial is a 12 week multi-disciplinary intervention involving exercise, nutrition advice and education sessions

Rehabilitation programme

Juliette Hussey, PhD

The ReStOre trial is a multi-disciplinary intervention of exercise, diet and education for patients who have completed treatment for oesophageal cancer. The intervention aims to improve quality of life and functional performance following oesophageal cancer and assist patients to return to normal activity during the early survivorship phase. The 12-week intervention will involve structured exercise training, individual dietary advice and multi-disciplinary education sessions addressing a range of survivorship needs.

The principal study proposed in this work will be composed of two phases. Phase I will consist of a longitudinal analysis, tracking the progression of cachexia and associated dysmetabolic state throughout treatment for oesophageal cancer (OC) and examining the impact of this decline on measures of physical functioning. A total of 88 newly-diagnosed OC patients will be recruited for Phase I. In Phase II, participants from Phase I will be re-assessed and if deemed suitable, will be enrolled onto a multidisciplinary team rehabilitation programme aimed at improving functional status. This rehabilitation programme will take the form of a randomised controlled trial (RCT) and will be based on the well-established cardiac rehabilitation programme model. It is anticipated that approximately 50% of participants enrolled onto Phase I will be suitable for progression to Phase II.

Outcomes The primary outcome across both Phase I and Phase II is functional capacity. Secondary outcomes including inflammatory status, energy metabolism and nutritional status will be measured as appropriate during the study. All outcomes are discussed in detail elsewhere.

Phase I: Longitudinal Study Examining the impact of progressive cachexia, dysmetabolism and cancer treatment on functional capacity in OC patients

Phase I will be designed as a longitudinal analysis, commencing at the time of diagnosis, tracking the progression of cachexia and associated dysmetabolic state, incorporating inflammatory profiles, energy metabolism (oxidative phosphorylation and glycolysis) and gut hormones, throughout treatment for OC and examining the impact of this decline on measures of physical functioning. Assessments will be completed at diagnosis (T0), cycle 2 chemotherapy (T1), cycle 3 chemotherapy (T2), pre-oesophagectomy (T3), post-oesophagectomy (T4), 4-weeks post-surgery (T5) and six months post-surgery (T6). All assessments will be completed during the same day as routine out-patient appointments thereby reducing the burden on participants. Furthermore, blood samples will be taken during routine clinical sampling and CT scans will be completed as part of routine medical care.

Phase II: Randomised Controlled Trial Can rehabilitation following curative treatment for OC optimise health-related functional outcomes?

Phase II will examine the effect of a 12-week rehabilitation programme, incorporating a walking intervention, individualised nutritional advice and education session, on functional status following curative treatment for OC. Following completion of Phase I and medical clearance to progress to Phase II, participants will be randomised 1:1 to either the intervention group or a control group. The control group will not receive the intervention however following completion of final assessments, participants will be offered an individual exercise and dietary session with the research physiotherapist and dietitian. During the intervention period, participants in the control group will continue to receive routine medical care.

The primary outcome for the multidisciplinary rehabilitation programme will be a change in functional capacity as measured by aerobic capacity. Secondary measures of functional capacity will include a stair climbing test, hand grip and physical activity. Body composition will also be measured by bio impedance analysis. The secondary outcomes that will be assessed are nutritional status, dietary quality and healthy related quality of life (QOL). Inflammatory profiles, measures of energy metabolism and gut hormones are unlikely to be influenced by the proposed rehabilitative intervention and therefore will not be measured. Assessments will be completed at, programme completion and three months post programme completion. Assessments take place at the Welcome Trust-HRB Clinical Research Facility St. James's Hospital. The rehabilitation programme will consist of three main components; 1. Exercise session, 2. Dietary sessions and 3. Education sessions. The intervention outlined below is devised based best evidence, pilot data and clinical expertise. The design final design will be informed form the results of the feasibility study and from needs identified in Phase I.

Exercise Sessions The exercise component of the rehabilitation programme will take the form of a 12 week supervised and home-based walking intervention. A walking intervention was chosen as walking is the most common form of exercise completed by adults nationally and worldwide, it is safe and feasible for deconditioned cohorts and represents a functionally meaningful activity. The feasibility of implementing a similar programme in cancer survivors has been previous established.

Group walking sessions will be supervised twice weekly during the first four weeks of the programme to re-introduce exercise to participant's lives in a safe and structured manner. As the programme progresses the frequency of supervised sessions will decrease to increase participants independence with the protocol. In the absence of guidance on appropriate exercise prescription in cancer cohorts, exercise intensity will be prescribed in accordance with the American College of Sports Medicine (ACSM) guidelines for exercise in deconditioned populations (28). Initially, activity will be prescribed at a light intensity and will progress during the programme to a moderate aerobic intensity. The proposed starting intensity is based on pilot data from the investigators institute suggesting that aerobic fitness levels are either 'poor' or 'very poor' in the early post-treatment phase. Participants will wear Polar Heart Rate monitors during all sessions to ensure compliance with the exercise prescribed. The goal at programme completion will be participation in 30 minutes of moderate intensity activity five days per week, as per the ACSM physical activity guidelines.

Nutrition Sessions Nutrition sessions will be delivered during week 1, week 2 and then fortnightly on a one to one basis. Weight and circumferential measures will be recorded at each session and dietary intake will be assessed as described previously.

The education delivered in the nutrition sessions will be individualised to participants needs. There is limited knowledge of the specific nutritional needs of oesophageal cancer survivors. Based on experience at this centre, the investigators anticipate that a heterogeneous mix of dietary issues requiring intervention will present in this cohort. These include persistent weight loss, anorexia, gastrointestinal disturbance and altered bowel habit. In addition, participants may require specific dietary advice to reduce the risk of other diseases e.g. cardio-protective dietary advice. Furthermore, the increase in physical activity by participants throughout the intervention will require dietary monitoring and advice to avoid inappropriate negative energy balance.

The feasibility study will assist in identifying specific nutritional issues facing oesophageal cancer survivors and help inform content and delivery of the nutrition education sessions. The target for participants is optimal dietary intake in line with the WCRF guidelines for cancer survivors. Supporting literature detailing prescriptive dietary advice will be developed and provided to participants.

Education Sessions Education sessions will be delivered weekly during weeks 1-4 and fortnightly thereafter by a range of members of the multidisciplinary team. As per the cardiac rehabilitation model, education sessions will talk place after the exercise session and cool-down, to monitor participant recovery following exercise. Education topics covered by the physiotherapist will include advice regarding physical activity guidelines, discouraging sedentary behaviour and overcoming barriers to physical activity. The dietitian will discuss dietary management of gastrointestinal symptoms and will also educate participants on healthy eating for cancer survivors as per World Cancer Research Fund, including practical advice and strategies to achieve dietary goals. Participants will be encouraged to highlight topics that may be of particular concern to them for discussion. As per the cardiac rehabilitation model, such topics may be covered by members of the multi-disciplinary team including the surgeon, gastrointestinal nurse, occupational therapist or social worker. Education sessions will take place at the Welcome Trust-HRB Clinical Research Facility St. James's Hospital.

Rehabilitative Strategies Following Oesophageal Cancer

Aerobic fitness (ml/kg/min) will be measured by maximal cardiopulmonary exercise test

Physical activity (minutes per week) will be measured by accelerometry

Hand grip strength (kg) will be measured by as an estimate of overall body strength

Segmental body composition will be measured by bioelectrical impedence analysis. Sarcopenia will be assessment by PET-CT

Blood samples will be analysed for inflammatory cytokines (TNF-alpha and interleukin (IL)-6 as measured by multi-plex assays

Blood samples will be analysed for measures of energy metabolism (citrate secretion and lactate secretion)

EORTC questionnaire will be used to measure QOL

University College Dublin

University of Dublin, Trinity College

Professor

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Liver Extracts

300 or 500 calories nutritional support before operation according to the level of malnutrition

Dietary education was conducted according to preoperative nutritional requirements

300 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for Mild malnutrition, or 500 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for moderate to severe malnutrition. The degree of malnutrition is determined by Patient-Generated Subjective Global Assessment (PG-SGA).

300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber

Dietary mission

Chunlei Li, Doctor

Kun Wang, Doctor

Kun Wang

Objective:To confirm the effect of preoperative oral nutrition therapy on patients with malnourished before liver cancer resection.

Study design:Prospective, randomized, controlled clinical study. Primary end point: incidence of all complications 30 days after surgery.

Clinical Application of Nutrition Support Package Before Hepatectomy

Clinical Application of Preoperative Nutritional Support Package for Liver Cancer

Postoperative complications were defined by Clavien-Dindo. Grade 1： Any deviation from the normal postoperative course without the need for pharmacologic treatment or surgical, endoscopic, and radiologic interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgetics, and diuretics, and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.

Grade 2： Requiring pharmacologic treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.

Grade 3： Requiring surgical, endoscopic, or radiologic intervention 3a： Intervention not under general anesthesia 3b： Intervention under general anesthesia Grade 4：Life-threatening complication (including CNS complications) requiring IC/ICU management.

4a： Single organ dysfunction (including dialysis) 4b： Multiple organ dysfunction Grade 5： Death as a result of complications

from the date of the operation to the date of discharge

Tianjin Medical University Cancer Institute and Hospital

Esophageal Diseases

Omega 3 Fatty Acid

Patients receive omega-3 fatty-acid enriched enteral nutritional emulsion during the neoadjuvant chemoradiotherapy. Patients are meanwhile encouraged to intake 25-30kcal/kg through regular food.

Patients are encouraged to intake 25-30kcal/kg through regular food without supplemental nutritional support before esophagectomy.

Preoperative immunonutrition includes an omega-3 fatty-acid enriched enteral nutritional emulsion given by oral intake, nasogastric feeding tube or jejunostomy 600ml per day, lasting for the whole period of neoadjuvant chemoradiation. Meanwhile, oral intake is encouraged to reach 25-30kcal/kg through regular food.

Preoperative immunonutrition

Hecheng Li, PhD, MD

Yuqin Cao, MD

Chun Chen

Mingsong Wang

Dingpei Han, PhD, MD

Su Yang, MD

Zhigang Li

Lijie Tan

Jinyi Wang

Qixun Chen

Weiyu Shen

This randomized controlled trial will evaluate the effects of preoperative enteral immunonutrition in esophageal cancer patients undergoing neoadjuvant therapy. The purpose of this study is to determine whether preoperative immune-modulating diet before surgery can improve the rate of complications and other perioperative outcomes.

Esophageal cancer ranks the fourth in mortality and the sixth in incidence among cancers in China according to the latest report of cancer epidemiology. Although the development of neoadjuvant therapy and radical esophagectomy have improved the prognosis of esophageal cancer patients, dysphagia and digestive tract reconstruction can cause malnutrition and infection-related complications. Postoperative enteral and parenteral nutrition have proved to be effective in improving outcomes after esophagectomy. However, whether to provide a preoperative nutritional support for patients with resectable esophageal cancer remains controversial.

This prospective randomized controlled trial will evaluate the effects of preoperative enteral immunonutrition in esophageal cancer patients undergoing neoadjuvant therapy. The purpose of this study is to determine whether preoperative immune-modulating diet before surgery can improve the rate of complications and other perioperative outcomes.

The sample size is estimated with the hypothesis that preoperative immunonutrition during the neoadjuvant therapy can reduce postoperative nutrition and immune-related complications after esophagectomy. According to the previously published articles, the required sample size of interventional and control arm (ratio=2:1) was calculated as 137 cases and 69 cases to detect the reduction in related complications from 50% to 30% based on a bilateral significance level (α) of 0.05 and a power of test (1-β) of 0.80. Considering an estimated drop rate of 15%, the minimum sample size of this study is 244 patients, 162 cases in the interventional group and 82 in the control group. After signing the informed consent, every eligible participant will be randomized into either group based on a computer-generated random number. Blinding will not be applied to patients and surgeons due to the difficulty in clinical practice but outcomes assessor will be masked.

Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy

Rate of gastrointestinal complications (anastomotic leakage, gastrointestinal dysfunction), metabolic complications (electrolyte disturbances, liver or renal dysfunction) and infectious complications(wound infection, catheter-related infection, pneumonia, sepsis, or other infections requiring antibiotics).

Conversion to open surgery, recurrent nerve injury, cardiac and cerebrovascular accident

WBC, hemoglobin, albumin, CRP, TNF-α, interleukins, IgA, IgG, IgM, fasting blood-glucose

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer	NCT02598479	Cancer	IPTLD and nutri...	18 Years -	Best Answer for Cancer Foundation
Impact of Symbiotic Administration on Intestinal Function of Head and Neck Patients Surgically Treated	NCT02654652	Head and Neck C... Synbiotics Nutrition Thera...	Symbiotic Maltodextrin	18 Years -	Federal University of Minas Gerais
Nutritional Intervention and DNA Damage of Patients With HBOC	NCT05306002	HBOC Syndrome DNA Damage Nutrition Thera...	Antioxidant the...	18 Years -	Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
A Quality of Life Study Using Insulin Potentiation Targeted LowDose (IPTLD) Chemotherapy and Nutrition Therapy in the Treatment of Cancer	NCT02598479	Cancer	IPTLD and nutri...	18 Years -	Best Answer for Cancer Foundation
Rehabilitative Strategies Following Oesophageal Cancer	NCT03314311	Esophageal Canc...	Rehabilitation ...	-	University of Dublin, Trinity College
Clinical Application of Nutrition Support Package Before Hepatectomy	NCT04218253	Liver Neoplasms Nutrition Thera... Hepatectomy	300 calories or... Dietary mission	18 Years - 80 Years	Tianjin Medical University Cancer Institute and Hospital
Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy	NCT04513418	Esophageal Neop...	Preoperative im...	18 Years - 75 Years	Ruijin Hospital
Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition	NCT04436965	Nasopharyngeal ... Nutrition Thera...	Standardized nu... Cisplatin Intensity Modul...	18 Years - 65 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for nutrition therapy