Three sessions per week of concurrent training during radiotherapy period. Each session will begin with warm-up (5-min cardiovascular activity at low-moderate intensity, joint mobility and one set of resistance exercises circuit at 30-40% 1RM). Resistance training will follow the warm-up, including 9 standard exercises involving major muscle groups of the lower and upper body: vertical bench press, parallel bar dip for triceps, seated rowing, standing dumbbell curl for biceps, leg press, deadlift and shoulder press. All these exercises will be realized following circuit training with 4 sets of 8-12 repetitions, using a training load of 70-80% RM. When patient will able to complete more than 12 repetitions, load will be increased progressively 10%. Cardiovascular training will be completed 20-30 min after resistance training, and it will include High-Intensity Interval Training (HIIT) of 3 min near to the second ventilatory threshold and 2 min near to the first ventilatory threshold.

Prescribed diet controlling macronutrients according to patient body weight (~4g/kg/day for carbohidrates, ~2g/kg/day for proteins, and ~1g/kg/day for fats). Patient will take one single dosage per day of probiotics (Arkoprobiotics® Defenses), 1 or 2 capsules of omega-3 fish oil concentrate (Solgar®, 600-1200mg depending on fat sources intake during the day), and a combine ingestion of 3g beta-hydroxybeta-methylbutyrate (HMB), 14g arginine, and 14g glutamine (HSN Raw Series®, all pure ingredients and making the ingestion adding each of them individually in a solution with 300-400 ml of water). During concurrent training sessions, between resistance exercise and HIIT, patient will also take 6g of BCAA's (HSN Raw Series®, 2:1:1) along with a banana. Additionally, patient could take whey isolated protein (Amix® IsoPrime CFM) to meet with some of the prescribed proteins intakes.

Body Weight Changes

Physical exercise controlled program supervised by an accredited exercise specialist

Physical exercise

Nutritional management controlled by a PhD clinical and sport nutrition specialist

Nutritional management

Francisco de Vitoria University (UFV)

Concurrent Training and Nutritional Management in Cancer

Concurrent Training and Nutritional Management Prevent Body Weight Loss During Radiotherapy in a Young Adult With Head and Neck Cancer: A Case Control Study

Test will be performed in vertical bench press

Test will be performed in a cycloergometer

Luis Berlanga

Principal Investigator

Universidad Francisco de Vitoria

20ml of whole blood will be drawn from each subject each time they are asked to have blood drawn. The total amount of blood collected from subjects will not exceed 360 ml (1.5 cups) within any eight week period throughout the two year timespan patients may be asked to participate in this study.

Acute Humoral Rejections

Chronic Humoral Rejections

Transplant

Patients will be asked to provide blood for immune tests.Patients will not take any study medications, all the research will be performed on blood donated for the study.Patients will donate about 20mls of blood (2 tbls)to be used to determine the subject's blood group and tissue typing (genetic).Results and the patient's contact information will be maintained in a database that is accessible only by the investigators and study personnel conducting the study.For the duration of this study, the investigator will contact patients by phone to request additional samples when needed. Study staff may ask patients donate more blood on short notice (1 day). This will consist of 60-120 ml (6-12 tbls) of blood.The frequency of blood collection will not exceed more than 2 times per week.The total amount of blood collected from subjects will not exceed 360 ml (1.5 cups) within any eight week period throughout the two year timespan patients may be asked to participate in this study.

Blood Draws

Northwestern University Comprehensive Transplant Center

Effects of Thymoglobulin on Human B Cells

Effects of Thymoglobulin on Proliferation, Activation, and Differentiation of Human B Cells

3-6x106 cells of interest will be labeled with 1.5μM CFSE before stimulation. After 6 days, B cells will be recovered, washed, counted and used to define marker settings. The cell phenotype will be analyzed by five-color flow cytometry (FC500, Beckman-Coulter) and by 13-color flow cytometry (Fortessa) and data will be analyzed using CXP software. The supernatant of these B-cell cultures will be using for the cytokines detection, and to determine the number of IgM and IgG producing cells by Luminex.At day 6, cells will be re-stimulated with phorbol 12-myristate 13-acetate (PMA) and Ionomycin, and analyzed by intracellular cytokine staining. Total CD19+ B cells will be sorted into a CD27- (naïve) and CD27+ (memory) B-cell fraction and the phenotypic characterization (assessed by flow cytometry) of these cells will be showed after 6 days of culture with anti-IgM (5μg/ml), anti-CD40 (100ng/ml), and IL-21 (100ng/ml) in the presence or absence of the drugs.

The investigators will co-culture B cells (pre-stimulated with α-IgM and α-CD40 mAb plus IL-21 for 6 days in the presence and absence of Thymoglobulin) with allo-CD4+CD25- T cells (ratio 2:1). After 6 days the investigators will analyze the % of proliferated T-cells and the cytokine production.

Lorenzo Gallon

Professor

Northwestern University

Sanofi

Arm A includes 14 patients. In treatment period 1, arm A receives standard PDF with the interventional drug alanyl-glutamine-dipeptide as add-on. As it is a cross-over study design, in treatment period 2, group A receives standard PDF without add-on.

Arm B includes 14 patients who in treatment period 1 receive standard PDF without the investigational drug. As it is a cross-over study design, in treatment period 2 arm B receives standard PDF with alanyl-glutamine-dipeptide as add-on.

End Stage Renal Disease

Two arms (A and B) and two treatment periods (1 and 2) are scheduled for this study. Each arm includes 14 patients. Schedule arm A: Treatment period 1 with one single peritoneal dialysis exchange (standard PD solution) with Alanyl-Glutamine-Dipeptide as add-on. 17,4 ml Dipeptiven (=3,48g N(2)-L Alanyl-L-Glutamin) will be dissolved at a final concentration of 0,174 %(= 8 mmol/l) in 2 liters of Dianeal®PD4 (at PH:5,5; Glucose-Concentration 3,86 %). After a wash out period (28 days + max 7 days), arm A undergoes treatment period 2, that is one single peritoneal dialysis exchange with standard PD solution without Alanyl-Glutamine-Dipeptide. Schedule Arm B: Treatment period 1 with one single peritoneal dialysis exchange with standard PD solution without Alanyl-Glutamine-Dipeptide followed by wash-out. Treatment period 2 for arm B includes one single peritoneal dialysis exchange with standard PD solution with Alanyl-Glutamine-Dipeptide as add-on. Dosages remain exactly the same.

Dipeptiven (Alanyl-glutamine-dipeptide)

Department of Internal Medicine III; Clinical Division of Nephrology and Dialysis; Medical University of Vienna

Safety and Efficacy of the Addition of Alanyl-Glutamine-Dipeptide to Dialysis Solution in Peritoneal Dialysis

An Open Label, Randomized, Two-Period Crossover Study to Evaluate the Safety and Efficacy of the Addition of Alanyl-Glutamine-Dipeptide to Dialysis Solutions in Peritoneal Dialysis (PD) (Ala-Gln in PD)

In this study, an increase of total heat shock protein expression will be detected in cells from the peritoneal effluent at 240 min by staining of the cytospin and by Western blot analysis of the cellular pellet of the effluent. Total heat shock expression from dialysate samples is calculated in percent.

The ratio of solute concentrations in dialysate and plasma (D/P ratio) at specific times (t) during the dwell signifies the extent of solute equilibration. Creatinine, glucose, urea, electrolytes, phosphate, and proteins are the commonly tested solutes for clinical use, in this study alanine, glutamine and alanyl-glutamine-dipeptide also will be measured to allow assessment of the respective resorption kinetics.

At the end of PD, total peritoneal cell count of the dialysate is measured; Unit of measurement: cells/µl

At the end of PD cytokines contained in the dialysate are being analysed. Unit of measurement: pg/ml

Analysis of cell function in dialysate at the end of PD by declaring the contingent of positive cell function in percent;

At the end of PD, the cells contained in the dialysate are being differentiated in following categories: ephitelium; non epithelium; mixed.

At the end of PD, the amount of CA125 in the dialysate is measured in U/ml.

During the trial and after signing informed consent, the presence/absence/severity of AEs occurring to patients is being documented. Measurement parameter is no. and severity of AEs (including SAEs and SUSARs).

Christoph Aufricht

Ao.Univ.-Prof. Dr.med.univ.

20 cc three times daily for 60 days plus radiation therapy.

Cancer-related Problem/Condition

Head and Neck Cancer

Pain

glutamine

Per institutional standard; minimum of 6,000 cGy with a daily dose of 180-200 cGy.

radiation therapy

l-glutamine placebo

MBCCOP - Gulf Coast

CCOP - Western Regional, Arizona

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

Veterans Affairs Medical Center - Tucson

Arizona Cancer Center at University of Arizona Health Sciences Center

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Veterans Affairs Medical Center - Little Rock (McClellan)

City of Hope Comprehensive Cancer Center

Veterans Affairs Medical Center - Long Beach

USC/Norris Comprehensive Cancer Center and Hospital

Veterans Affairs Medical Center - West Los Angeles

Jonsson Comprehensive Cancer Center, UCLA

Veterans Affairs Outpatient Clinic - Martinez

CCOP - Bay Area Tumor Institute

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

University of California Davis Cancer Center

UCSF Comprehensive Cancer Center

CCOP - Santa Rosa Memorial Hospital

David Grant Medical Center

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Veterans Affairs Medical Center - Denver

MBCCOP - Howard University Cancer Center

Veterans Affairs Medical Center - Tampa (Haley)

CCOP - Atlanta Regional

Dwight David Eisenhower Army Medical Center

MBCCOP - Hawaii

Tripler Army Medical Center

MBCCOP - University of Illinois at Chicago

Veterans Affairs Medical Center - Chicago (Westside Hospital)

CCOP - Central Illinois

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Genesis Regional Cancer Center at Genesis Medical Center

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

CCOP - Wichita

Veterans Affairs Medical Center - Wichita

Veterans Affairs Medical Center - Lexington

Markey Cancer Center at University of Kentucky Chandler Medical Center

MBCCOP - LSU Health Sciences Center

Tulane Cancer Center at Tulane University Hospital and Clinic

Veterans Affairs Medical Center - New Orleans

Veterans Affairs Medical Center - Shreveport

Louisiana State University Health Sciences Center - Shreveport

Cancer Research Center at Boston Medical Center

Veterans Affairs Medical Center - Ann Arbor

CCOP - Michigan Cancer Research Consortium

University of Michigan Comprehensive Cancer Center

Barbara Ann Karmanos Cancer Institute

Veterans Affairs Medical Center - Detroit

Josephine Ford Cancer Center at Henry Ford Hospital

CCOP - Grand Rapids

CCOP - Beaumont

Providence Cancer Institute at Providence Hospital

CCOP - Duluth

University of Mississippi Medical Center

Veterans Affairs Medical Center - Jackson

Keesler Medical Center - Keesler Air Force Base

CCOP - Kansas City

St. Louis University Hospital Cancer Center

CCOP - St. Louis-Cape Girardeau

CCOP - Cancer Research for the Ozarks

CCOP - Montana Cancer Consortium

Veterans Affairs Medical Center - East Orange

Veterans Affairs Medical Center - Albuquerque

MBCCOP - University of New Mexico HSC

NYU School of Medicine's Kaplan Comprehensive Cancer Center

Herbert Irving Comprehensive Cancer Center at Columbia University

James P. Wilmot Cancer Center at University of Rochester Medical Center

Veterans Affairs Medical Center - Salisbury

CCOP - Southeast Cancer Control Consortium

Veterans Affairs Medical Center - Cincinnati

Charles M. Barrett Cancer Center at University Hospital

Cleveland Clinic Taussig Cancer Center

CCOP - Columbus

Arthur G. James Cancer Hospital - Ohio State University

Veterans Affairs Medical Center - Dayton

CCOP - Dayton

CCOP - Toledo Community Hospital

Oklahoma University Medical Center

Cancer Institute at Oregon Health and Science University

Veterans Affairs Medical Center - Portland

CCOP - Columbia River Oncology Program

Veterans Affairs Medical Center - Charleston

Hollings Cancer Center at Medical University of South Carolina

CCOP - Greenville

CCOP - Upstate Carolina

Danville Radiation Therapy Center

University of Tennessee Cancer Institute

Harrington Cancer Center

Veterans Affairs Medical Center - Amarillo

Veterans Affairs Medical Center - Dallas

Brooke Army Medical Center

University of Texas Medical Branch

University of Texas - MD Anderson Cancer Center

Veterans Affairs Medical Center - Houston

University of Texas Health Science Center at San Antonio

Veterans Affairs Medical Center - San Antonio (Murphy)

Veterans Affairs Medical Center - Temple

CCOP - Scott and White Hospital

Huntsman Cancer Institute

S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat

S9908, A Double-Blind, Placebo-Controlled Trial To Study The Efficacy And Safety Of L-Glutamine (In AES0014 Delivery Vehicle) Upon Radiation Therapy-Induced Oral Mucositis In Head and Neck Cancer Patients, Phase III

Evaluate effectiveness of L-glutamine as compared to placebo in terms of: maximum toxicity grade during radiation treatment, mucositis toxicity grade 2 weeks after the end of radiation treatment, and patient reported worst mouth pain two weeks after the end of radiation treatment.

Southwest Oncology Group

National Cancer Institute (NCI)

dental caries

glutamine/dental caries

Concurrent Training and Nutritional Management in Cancer

Effects of Thymoglobulin on Human B Cells

Safety and Efficacy of the Addition of Alanyl-Glutamine-Dipeptide to Dialysis Solution in Peritoneal Dialysis

S9908: Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat

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