Nutritional and Metabolic Diseases

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Behaviors and Mental Disorders

Malnutrition

Lung Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Nutrition Disorders

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Diseases

Quality of Life

Other Dietary Supplements

All Drugs and Chemicals

Amino Acids

Whey Protein

Leucine

standardized nutritional program including a nutritional supplement

standardized exercise program

app for monitoring.

standard of care

limited version of the app (e.g. without the "help" function).

The whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) is ingested once daily, preferably either in the evening before going to bed or within two hours after having finished exercising.

Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB)

During at least two personal counseling meetings with a dietician, the patient's diet is assessed and individual nutritional interventions - based on the personal needs and individual preferences of the patient - are developed. The overall goal is to optimize protein an energy intake.

Standardized nutritional program

In at least two personal counseling meetings with a physiotherapist, the patient's individual training plan is compiled and agreed upon (mainly including strength, endurance and balance exercises). The patient then exercises at home and records the trainings with the app.

Standardized exercise program

Lucia Gafner, Dr. sc. nat.

Lena Storck, Dr. rer. med.

Acimic Christina

Migle Link, Dr. med.

Lena J Storck, Dr. (rer.) med.

Yvonne Krepp, Dr. med.

Barbara Rohrbach

Christoph Ackermann, Dr. med.

Lena J. Storck, Dr. (rer.) med.

Miklos Pless, Prof. Dr. med.

The main purpose of the study is to investigate whether a tailor-made nutritional and exercise program including home-based sessions and regular monitoring using an application on the smartphone is effective in improving Quality of Life in patients with advanced lung or gastrointestinal tract cancer.

Cachexia is highly prevalent among cancer patients and has substantial impact on the Quality of Life (QoL) and the functional status of patients.Therefore, the main purpose of this study is to investigate whether a mainly home-based nutritional and exercise program including regular monitoring using an application on the smartphone is effective in improving QoL in patients with advanced lung or gastrointestinal tract cancer.

The study desing is a randomized, two-arm and multicenter international trial and advanced lung or gastrointestinal cancer patients not eligible for curative treatment make up the patient population.

Patients in the intervention group receive a nutrition and exercise program in combination with an electronic application for data collection and monitoring.

The nutritional program comprises an extensive nutritional assessment and an individual nutritional recommendation. In addition, patients receive a whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) to support an optimal protein intake in combination with physical activity. The nutritional situation is reassessed at 2 -3 weeks.

Exercise counselling includes at least two visits with an extensive first baseline assessment. On this basis, an individual training program for 12 weeks in a home-based setting is compiled, with mainly strength and endurance exercises. At week 2-3, the patient and the study physiotherapist have a follow-up meeting.

The application Swiss NutriAct is mainly used for data collection (nutritional, exercise and QoL data). Since the study coordinator, dietician and physiotherapist can see the information entered by the intervention group patients, they can contact patients and offer help regarding the nutrition and exercise program, where deemed appropriate. Vice versa, patients can use the help button to contact the study team to ask questions regarding the nutrition and exercise program.

Patients in the control group receive standard of care and a limited version of the application.

Both arms will be assessed at baseline (0 weeks), after the 12 weeks intervention phase and at a follow up assessment after 24 weeks.

Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients

Influence of a Home-based Nutrition and Exercise Program Including an Application for Monitoring on Quality of Life in Palliative Cancer Outpatients

There is no plan to share individual participant data (IPD) with other researchers.

Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G)

Body weight (in kg), used in combination with body height to calculate BMI (in kg/m2)

Patient-generated subjective global assessment (PGSGA)

Muscle mass: L3 image of computertomographic (CT) measurements taken in the context of standard cancer therapy (divided by height squared; in cm2/m2)

Sarcopenia screening questionnaire SARC-F

60 s sit-to-stand test (number of stands)

Data collected with application, Harris-Benedict formula

Questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

Physical performance status (WHO performance status, grade 0-5)

According to data collected with application

Questionnaire mHealth App Usability (MAUQ)

Number of eligible patients, participants, rejections as compared to similar past studies

Krebsforschung Schweiz, Bern, Switzerland

Sponser Sport Food AG

Leitwert GmbH

SNAQ AG

Kantonsspital St. Gallen CTU

Kantonsspital Winterthur KSW

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Urinary Bladder Neoplasms

Gallbladder Neoplasms

Stomach Diseases

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Stomach Cancer

Esophageal Cancer

Pancreatic Cancer

Gallbladder Cancer

Antineoplastic Agents

Antirheumatic Agents

Anti-Infective Agents

Analgesics

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Aldesleukin

Immunomodulating Agents

Interleukin-2

Mesna

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Analgesics, Non-Narcotic

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine +escalating doses of CISH inactivated TIL + high-dose aldesleukin

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MTD of CISH inactivated TIL

Day -6 and Day -5: Cyclophosphamide 60 mg/kg/dose as a 2 hour intravenous infusion with Mesna 15 mg/kg/dose, 1st dose prior to Cyclophosphamide infusion then at 3,6,9 and 12 hours later.

Day -7 to Day -3 : Fludarabine 25 mg/m\^2/dose as a 1 hour intravenous infusion per institutional guidelines once a day for 5 doses beginning on Day -7. Fludarabine will be started approximately 1 to 2 hours after the cyclophosphamide on Day -6 and Day -5.

Day 0 : Each bag of autologous CISH inactivated TIL for infusion will be administered intravenously (IV) on the Patient Care Unit over 10-20 minutes at assigned dose level.

Tumor-Infiltrating Lymphocytes (TIL)

Days 1-4 : Aldesleukin at 720,000 U/kg as an intravenous infusion, every 8 -12 hours but, no more than 24 hours apart as tolerated for up to 6 doses.

Cancer Center Clinical Trials Office

Dr. Emil Lou, MD, PhD

Emil Lou, MD, PhD

A clinical trial to assess the safety and efficacy of genetically-engineered, neoantigen-specific Tumor Infiltrating Lymphocytes (TIL) in which the intracellular immune checkpoint CISH has been inhibited using CRISPR gene editing for the treatment of Gastro-Intestinal (GI) Cancer.

Tumor Infiltrating Lymphocytes (TIL) have shown efficacy in certain cancers, principally in melanoma. Efficacy in more common solid tumors has been demonstrated via the selection of cancer neoantigen-specific TIL. Combination cell surface checkpoint inhibitor therapy has also been employed in an attempt to enhance the efficacy of these cell therapies. Genetic engineering of T cells to further increase anti-tumor activity is now possible.

CISH (Cytokine-induced SH2 protein) is a novel intra-cellular immune checkpoint and an important negative regulator of T-cell signaling and function. The inhibition of CISH in mouse anti-tumor lymphocytes results in a marked increase in the ability of these lymphocytes to mediate tumor regression following administration to tumor bearing mice.

Additionally, data in genetically-engineered, neoantigen-specific human T cells in which CISH was inhibited, showed enhanced TCR functional avidity and increased ability of these T cells to detect cancer specific mutations and mount robust polyfunctional cytokine immune responses against their cognate cancer antigens. Thus, these T cells appear to have a significant advantage in inducing anti-tumor responses compared to wild-type anti-tumor lymphocytes.

The researchers have developed and optimized a CRISPR/Cas9 based strategy for precise and efficient genetic engineering in primary human T-cells without sacrificing cell viability or function, allowing for inhibition of a heretofore undruggable intracellular checkpoint.

Thus, in this protocol, the researchers propose to inhibit the gene encoding the intracellular checkpoint target CISH in lymphocytes from patients with metastatic cancers that are selected for anti-tumor activity in order to evaluate the safety and efficacy of genetically engineered T cell therapy for solid tumors in the setting of novel checkpoint inhibition.

A Study of Metastatic Gastrointestinal Cancers Treated With Tumor Infiltrating Lymphocytes in Which the Gene Encoding the Intracellular Immune Checkpoint CISH Is Inhibited Using CRISPR Genetic Engineering

A Phase I/II Trial in Patients With Metastatic Gastrointestinal Epithelial Cancer Administering Tumor-Infiltrating Lymphocytes in Which the Gene Encoding CISH Was Inactivated Using the CRISPR/Cas9 System

Highest dose at which less than or equal to 1 of 6 patients experienced a DLT or the highest dose level studied if DLTs are not observed at any of the dose levels

Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST v1.1 criteria

Progression-Free Survival (PFS) of patients with metastatic gastrointestinal cancers treated using the autologous lymphocytes

Overall Survival (OS) of patients with metastatic gastrointestinal cancers treated using the autologous lymphocytes

Masonic Cancer Center, University of Minnesota

Intima Bioscience, Inc.

Nervous System Diseases

Central Nervous System Neoplasms

Urogenital Neoplasms

Nervous System Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Patients treated with Reflexion X1 with SBRT as the standard of care

Patients treated with Reflexion X1 with IMRT as the standard of care

Registry - Observational

Debradenise Brooks

Didem Aksoy

Joan Marcia

Diamond Ward

Tu Dan, MD

Sean Shirvani, MD

Karine Feghali, MD

The purpose of this prospective cohort study is to assess clinical and quality of life measures as well as to define the severity of adverse effects for the use of the RefleXion system to deliver intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), in standard of care (SOC) use in the treatment of local,loco-regionally advanced, and oligometastatic malignancies. In addition, patient costs and charges will be analyzed to quantify the health economic impact of this modality. Workflow and quality of radiotherapy planning including a collection of dosimetric data will also be analyzed.

This is a multi-center prospective registry designed to assess the efficacy of IMRT and SBRT delivered via the RMRS. The study will seek to enroll approximately 500 patients initially and then remain open to further patients beyond at the discretion of the study sponsor and participating institutions. The number of IMRTandSBRT patients expected to enroll for the initial period is as follows:

* N = 250 IMRT
* N = 250 SBRT

Patients diagnosed with local, locoregionally advanced, or metastatic malignancies will be treated with IMRT or SBRT using the RMRS, with total dose, fractionation, and concurrent systemic therapy delivered according to the direction of the radiation oncology care team. The target population is patients for whom standard radiotherapy is prescribed using IMRT or SBRT. Data will be stratified by common radiotherapy divisions as follows:

* Central Nervous System (Brain, spinal cord, and vertebral column)
* Head and Neck
* Thoracic
* Gastrointestinal
* Gynecologic
* Genitourinary
* Lymphoma
* Melanoma/Sarcoma/Extremity
* Non-Spine Bone and Other An additional substratum within each anatomic division will specify whether the treatment intent is for definitive treatment of the primary tumor (for early-stage or locally advanced disease), a definitive oligo/polymetastatic therapy, or a palliative therapy. Patients will be routinely assessed during their radiation course and thereafter for toxicity burden and HRQOL using the CTCAE v5, EORTC, and EuroQOL surveys. Patients will be assessed for 2years following their therapy. Other long-term follow-ups will capture data including routine laboratory evaluation, quality of life questionnaires, performance status, routine radiographic assessments, physical exams, etc.

Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System

Prospective Data Registry and Quality of Life Assessment of PatientsUndergoing Radiotherapy With the RefleXion Medical Radiotherapy System (PREMIER Registry)

Evaluate patient-reported quality of life after IMRT or SBRT treatment delivered by the RefleXion system by assessing EORTC QLQ-C30.

The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.

Long-term Health-Related Quality of Life (HRQOL) scores, including the EORTC QLQ-C30 at 6 months, 9 months, 12 months, 18 months, and 24 months.

The EORTC questionnaire has a scoring of 0 to 100 and is disease-specific. 0 is none/minimal symptoms and normal/good functional ability. 100 is increased/severe symptoms and decrease/poor functional ability.

The EuroQOL-5D-FL (EQ-5D) will be used in parallel with the Health-Related Quality of Life (HRQOL) surveys to measure quality-adjusted life years.

The EQ-5D comprises five questions on mobility, self-care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem. A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.

Proportion of patients with acute treatment toxicity for the anatomic site undergoing treatment

Evaluate progression-free survival after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above. For prostate cancer cohort, biochemical progression-free survival will also be measured.

Evaluate local control after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above.

Evaluate regional control after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above.

Evaluate distant control after intensity-modulated radiotherapy or stereotactic body radiotherapy for the cancers above.

Evaluate overall survival after intensity modulated radiotherapy or stereotactic body radiotherapy for the cancers above.

Analyze resource utilization associated with the RefleXion system for the tumors above including the acute costs of intervention \& 6-month episodic costs.

Analyze long term treatment toxicity for the anatomic site undergoing treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients	NCT04859400	Cancer, Gastroi... Cancer, Lung Malnutrition	Whey protein su... Standardized nu... Standardized ex...	18 Years -	Kantonsspital Winterthur KSW
A Study of Metastatic Gastrointestinal Cancers Treated With Tumor Infiltrating Lymphocytes in Which the Gene Encoding the Intracellular Immune Checkpoint CISH Is Inhibited Using CRISPR Genetic Engineering	NCT04426669	Gastrointestina... Gastrointestina... Cancer of Gastr... Cancer, Gastroi... Gastrointestina... Colo-rectal Can... Pancreatic Canc... Gall Bladder Ca... Colon Cancer Esophageal Canc... Stomach Cancer	Cyclophosphamid... Fludarabine Tumor-Infiltrat... Aldesleukin	18 Years - 70 Years	Intima Bioscience, Inc.
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System	NCT05406167	Cancer Cancer Central ... Cancer Thoracic Cancer, Gastroi... Cancer Gynecolo... Cancer, Genito-... Cancers Lymphat... Cancer Head and...	Registry - Obse...	-	RefleXion Medical
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System	NCT05406167	Cancer Cancer Central ... Cancer Thoracic Cancer, Gastroi... Cancer Gynecolo... Cancer, Genito-... Cancers Lymphat... Cancer Head and...	Registry - Obse...	-	RefleXion Medical
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System	NCT05406167	Cancer Cancer Central ... Cancer Thoracic Cancer, Gastroi... Cancer Gynecolo... Cancer, Genito-... Cancers Lymphat... Cancer Head and...	Registry - Obse...	-	RefleXion Medical

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