Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Nervous System Diseases

Nutritional and Metabolic Diseases

Weight Loss

Muscle Weakness

Body Weight

Paresis

Asthenia

Wasting Syndrome

Cachexia

Syndrome

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Muscular Diseases

Neuromuscular Manifestations

Neurologic Manifestations

Other Dietary Supplements

All Drugs and Chemicals

Omega 3 Fatty Acid

Carnitine

"usual care" control group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight)

physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min)

+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight)

HMB supplemented group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d)

HMB supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min)

+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with HMB (3 g/d)

LC supplemented group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d)

LC supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min)

+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with LC (4 g/d)

EPA supplemented group receives individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d)

EPA supplemented physical exercise group performing a regular WB-EMS Training (two WB-EMS trainings per week; each session for 20 min)

+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight) + specific dietary supplementation with EPA (2.2 g/d)

β-hydroxy-β-methylbutyrate (HMB)

L-carnitine (LC)

Eicosapentaenoic acid (EPA)

WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial

Whole-Body Electromyostimulation (WB-EMS)

Yurdagül Zopf, Prof. Dr. med.

Hans Joachim Herrmann, Dr. oec. troph.

Patients suffering from cancer often experience a loss of muscle mass and strength during disease and its therapy. Muscle wasting is the main characteristic of the so-called cancer cachexia syndrome and responsible for many therapy-related complications and a poorer prognosis of the patient. Stabilizing muscle mass should therefore be a great goal in cancer care. Physical exercise and nutrition are promising measures to combat cancer-related muscle atrophy but conventional exercise programs may not always be suitable for physical-weakened patients and increased catabolic processes are difficult to overcome by normal Nutrition - especially in advanced cancer. Therefore, the present study aims to test a combined approach of specific nutritional supplementation and exercise using the novel strength training method of Whole-Body electromyostimulation (WB-EMS). The study investigates the effect of a 12-week WB-EMS training combined with a dietary supplementation of β-hydroxy-β-methylbutyrate (HMB), L-carnitine (LC) or the omega-3-fatty acid eicosapentaenoic acid (EPA) on skeletal muscle mass, body composition, physical function, nutritional and inflammatory status, fatigue and quality of life in cancer patients undergoing oncological treatment. The results of this study may help to clarify the effectiveness of those combined interventions to counteract muscle wasting and other symptoms of cancer cachexia.

Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients

Effects of Physical Exercise in the Form of Whole-body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Therapy Using Specific Dietary Supplements on Cancer Patients Undergoing Curative or Palliative Anti-cancer Treatment

Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)

Isometric hand grip strength assessed by hand Dynamometer (in kg)

Six-minute-walk test (walking distance in m)

30 second sit-to-stand test (number of sit-to-stand cycles)

Blood collection and analysis of e.g. C-reactive protein (CRP), Albumin

University of Erlangen-Nürnberg Medical School

Neoplasms

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Malnutrition

Postoperative Complications

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Stomach Diseases

Stomach Cancer

Esophageal Cancer

The FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, \</≥15 kg/m2 for females and \</≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the normal FFMI group (FFMI ≥17 kg/m2 for male and FFMI ≥15 kg/m2 for female).

The FFMI was calculated as follows: FFMI = fat-free mass (kg)/height squared (m2). FFMI cut-off values (derived from BIA measurements, \</≥15 kg/m2 for females and \</≥17 kg/m2 for males). Patients with esophagogastric cancer were then divided into the low FFMI group (FFMI \<17 kg/m2 for male and FFMI \<15 kg/m2 for female).

no intervention

The present study aims to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the Global Leadership Initiative on Malnutrition (GLIM) criteria.

The GLIM criteria of malnutrition as a consensus lack of optimal combination in clinical validation. After the publication of the GLIM consensus, few studies have examined the effect of reduced FFMI on the clinical prognosis of patients with esophagogastric cancer, and whether the FFMI can be used as an effective diagnostic criterion of malnutrition in esophagogastric cancer needs to be further studied.

Therefore, the present study aims were to investigate the prognostic value of preoperative fat-free mass index for postoperative outcomes in patients undergoing esophagogastric cancer surgery, and to explore the role of the FFMI in the GLIM consensus for malnutrition.

GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer

The Application Value of Preoperative Fat-free Mass Index Within GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer

postoperative complications (infectious complications and noninfectious complications)

nutritional status ( such as: weight，albumin，prealbumin)

hospitalization cost(including: surgery and medicine costs)

Jiangsu Cancer Institute & Hospital

Subei People's Hospital of Jiangsu Province

Peking Union Medical College

Jinling Hospital, China

Professor

Wounds and Injuries

Sarcoma

Muscle Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Patients who have undergone functional muscle transfer to restore function after tumour surgery or injury, in which the tumour surgery or injury has resulted in functional loss.

Patients who have not undergone functional muscle transfer to restore function after tumour surgery or injury, in which the tumour surgery or injury has resulted in functional loss.

Muscle transfer to restore lower limb function

Functional muscle transfer

The purpose of this study is to assess patient's function after functional limb restoring surgery, performed after ablative tumour surgery or trauma. However, there are no studies as yet providing objective proof of the recovery of function after this type of surgery. This study will use 3D Gait Analysis, Environmental simulation and Patient Reported Outcome Measures to compare patients with function restoring surgery against patients without function restoring surgery.

Introduction

Rationale

The purpose of this study is to assess patient's function after functional limb restoring surgery, performed after ablative tumour surgery or trauma. However, there are no studies as yet providing objective proof of the recovery of function after this type of surgery.

Background information including literature review

Sarcoma surgery has progressed from limb amputation to limb preserving surgery since the early 1980s. Although this has been a major advance, a preserved limb does not equate to a functional limb. Patients may be left with significant disability and reliant on walking aids or braces, and unable to return to normal activities

The West of Scotland Sarcoma service has developed and refined surgical procedures to restore function in the lower limb after major resection surgery. This is one of the few centres in the world that have done significant numbers of function restoring surgeries, and are recognised as experts in this field, having published the protocol for functional reconstruction in the Journal of Bone and Joint Surgery and in the book Reconstructive Surgery of the Lower Extremity.

Procedures for functional restoration include Quadriceps reconstruction (to restore knee extension) - this is the most common type of functional lower limb reconstruction. Hamstring transfers were originally described for use in polio over a century ago, sartorius transfers, and free functional muscles transfers such as the latissimus dorsi or contralateral rectus femoris/ vastus lateralis.

Other techniques for functional reconstruction include anterior leg compartment reconstruction (to restore foot dorsiflexion/ prevent foot-drop) and posterior leg compartment reconstruction (to restore plantar-flexion). Techniques such as the free functional anterolateral thigh - rectus femoris muscle combined flap are also used.

Previous studies have not provided objective proof of restoration of gait, and have been limited to scores such as the Musculoskeletal Tumor Society Score (MSTS), range of motion, and Medical Research Council (MRC) grade power. These scores are of limited value in establishing whether a patient's gait is normal, and may be subject to investigator bias.

Two objective techniques will be used to assess normality of gait after functional reconstruction:

1. Three-dimensional clinical gait analysis (3DCGA) provides a robust and objective technique for measurement of how an individual walks both for clinical use and for research purposes.
2. Environmental Simulator (the Motek system at Strathclyde University): this is the only environmental simulator of its type out-with the Ministry of Defence in the United Kingdom. It provides simulated environments on a large projected screen with the patient attached to a safety harness, whilst walking on an adjustable treadmill. This allows simulation of urban environments, negotiation of trip hazards, walking up hills and shopping tasks. This will permit more tangible answers regarding the objective return to function of patients in an environmental context that they can understand eg "Will I be able to go hillwalking?" "Will I be safe to go shopping without crutches or a brace?".

Aim/Primary and Secondary Objectives

The aim of this study is to objectively assess the normality of gait after functional reconstructive surgery, and to assess whether patients can return to activities of daily living using the Environmental simulator

Methodology

Patients who have undergone functional reconstructive surgery will be identified from a prospectively held database. The patients will be invited to participate by letter and given an information sheet. Should the patient wish to participate in the study they will be invited to clinic to discuss the study with the senior researcher (SL) and sign a consent form related to gait analysis and the environmental simulator.

There are 3 components to the study:

1. Patient Reported Outcome Measurements - using validated questionnaires including the Toronto Extremity Salvage Score (TESS). Clinical assessment will include MRC grade power and range of motion.
2. 3D Gait analysis - this employs 3D cameras and pressure sensors to objectively assess the patient's ability to walk, and can identify subtle differences in gait that cannot be identified on questionnaires or on simple video analysis. Electromyography may be used to assess active muscle contraction as part of the gait analysis.
3. Environmental simulator - this will employ a state-of-the-art simulator that can assess a patient's ability to navigate simulated environments eg walking up a hill, navigating an urban environment, and shopping tasks.

Functional Muscle Transfers in Lower Limb Sarcoma: 3D Gait Analysis and Environmental Simulation

Functional Muscle Transfers to Restore Normal Function After Major Lower Limb Sarcoma/ Trauma - Assessment by Gait Analysis and Virtual Reality Environmental Simulation

Data will be shared on reasonable written request

Objective score from 3D Gait Analysis. This is a continuous score with no minimum or maximum score, where lower scores indicate better gait.

Descriptive outcome measure on ability to complete simulator tasks which replicate activities of daily living.

Patient reported outcome measure on function after surgery. This is a continuous score which is converted to a 0 to 100 score. Higher indicates better functional outcomes.

University of Strathclyde

NHS Greater Glasgow and Clyde

physical exercise group regular WB-EMS training (2 EMS trainings per week; each session for 20 min)

+ individualized nutritional support (dietary advices: daily protein intake \> 1.0 g/kg bodyweight)

This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function and quality of life of patients with malignant disease undergoing curative or palliative anti-cancer treatment

Effects of WB-EMS and Dietetic Treatment on Cancer Patients

Effects of Whole-Body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Support on Patients With Malignant Disease Undergoing Curative or Palliative Anti-cancer Treatment

Hand grip strength assessed by hand dynamometer (in kg)

Blood collection and analysis e.g. of C-reactive protein (CRP), Albumin

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Kidney Diseases

Polycystic Kidney Diseases

Liver Diseases

Cysts

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Kidney Diseases, Cystic

Congenital Abnormalities

Abnormalities, Multiple

Ciliopathies

Genetic Diseases, Inborn

Pathological Conditions, Anatomical

Polycystic Liver Disease

Hematinics

Liver Extracts

After catheterization of renal arteries, multiple coils are applied to embolize renal arteries until blood flow stasis

Renal artery embolization

Ared Wu, MD

Primary sarcopenia is used to describe aging and progressed with the physiologic decline. Secondary sarcopenia is associated many chronic disease, including acquired immune deficiency syndrome, cancer, chronic heart failure, chronic lung disease, liver cirrhosis, chronic kidney disease and rheumatoid arthritis. In the past, nutrition status is evaluated by body mass index, mid-upper -arm circumference and serum albumin. Bioelectrical impedance analysis is also a common method to measured body composition, but bioelectrical impedance analysis will be affected by tissue edema and ascites. In contrast, cross-section imaging, such as computed tomography and magnetic resonance can analyzed abdominal muscle and fat accurately.

Since computed tomography and magnetic resonance imaging can evaluate the severity of polycystic liver and kidney disease. Investigators can use cross section imaging at 3rd lumber level to separate skeletal muscle and fat tissue. Previous studies showed the quantity and quality of abdominal muscle are important prognostic factor after liver transplantation. Besides, chronic kidney disease and receiving renal placement therapy lead protein catabolism and make patients with end stage renal disease have sarcopenia. Finally, patients with polycystic liver and kidney disease have organomegaly, which causes abdominal distention and poor appetite. Therefore, the aim of this study is to observe the association between skeletal muscle mass and the severity of disease and to study whether change in hepatic and renal volumes is associated with change in muscle mass.

The imaging study (CT or MRI) will be performed within one month before the procedure to measure total kidney volume and psoas muscle area.

The procedure will use transcatheter embolization to renal artery. The follow-up imaging study will be performed six months after the procedure to measure total kidney volume and psoas muscle area..

hemogram, complete blood count, CBC renal function: BUN, Cr electrolytes: Na, K, Ca, P hypertension: plasma renin activity, aldosterone inflammation: CRP, IL-6、TNF-α、IL-1 liver function: AST, ALT, Albumin, T-Bil, PT, INR muscle: CPK, myostatin adipose: Cholesterol, TG, HDL, LDL, adiponectin

The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease

The change of psoas muscle area before and after procedures.

The change of total kidney volume before and after procedures

National Taiwan University Hospital

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Nicotine

Creatine

Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Participants will be given a fitbit (electronic watch that measures steps or heart rate) as well to track heart rate and monitor activity throughout the study.

Participants will not participate in the creatine intervention (creatine supplementation). Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Exercise sessions will be held by trained study staff held at the Medical Arts and Research Center Physical Therapy clinic (address listed above).

Those randomized to receive creatine (experimental group) will be initially dosed at 20 g/day for 7 days to boost availability of creatine systemically. Thereafter, the dose will be reduced to 5 g/day for maintenance through the duration of the 12-week protocol.

Darpan I Patel, PhD

The purpose of this study is to test the hypothesis that creatine will accelerate adaptations associated with exercise in breast cancer survivors recently completing chemotherapy.

The primary objective of this study is to determine the effects of creatine supplementation in modulating strength and physical function in breast cancer survivors that have recently completed chemotherapy. The primary hypothesis for this objective is that creatine will lead to significantly greater gains in strength and physical function in breast cancer survivors compared to exercise alone. The secondary objective is to determine if supplemental creatine can increase intramuscular storage of creatine and alter energy storage. The hypothesis for this objective is that creatine supplementation will significantly increase intramuscular concentrations of creatine (Cr), phosphocreatine (PCr) and adenosine triphosphate (ATP) in the vastus lateralis (VL) compared to controls. The secondary hypothesis for this objective is that the creatine group will have significantly greater muscle cross-sectional area and significantly lower intramuscular fat compared to controls. The final objective for this study is to test the hypothesis that creatine supplementation will improve body composition in breast cancer survivors.

This study plans to enroll 30 breast cancer patients who have completed chemotherapy within 6 months prior to consenting for this study. Patients eligible to participate in this study will be allocated to either the creatine group or the control group (1:1) based on a pre-determined randomization list. Each arm will have 15 participants. One arm will receive creatine and the other will serve as the control group with no creatine.

Effects of Creatine Supplementation in Breast Cancer Survivors

The THRIVE Study: An Open-Label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Breast Cancer Survivors

Participants will be evaluated for knee extensor strength via isometric maximum voluntary contraction at approximately 60° knee flexion.

Functional exercise capacity will be assessed via the 6 minute walk test (6MWT).

Muscle Creatine, Phosphocreatine, and Adenosine-triphosphate content will be assessed in vivo by 31P-MRS using a whole body 3.0T MRI scanner.

Magnetic resonance imaging will be used to capture the mid-thigh cross section.

ThriveWell Cancer Foundation

The University of Texas Health Science Center at San Antonio

Child Nutrition Disorders

Central Nervous System Stimulants

Analgesics

Psychotropic Drugs

Anti-Allergic Agents

Dermatologic Agents

Gastrointestinal Agents

Dronabinol

Cyproheptadine

Hallucinogens

Analgesics, Non-Narcotic

Neurotransmitter Agents

Hormones

Hormone Antagonists

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Serotonin

Standard of Care who have either weight gain, weight maintenance, or weight loss \<10%.

Those receiving ONS will be prescribed a standard ONS (1.0 kcal per mL) that will meet a minimum of 50% of estimated energy needs to promote weight gain but allow for continued regular dietary intakes. The ONS will be prescribed as 8oz (240mL) per dose at least once a day, but up to six times per day depending on estimated nutrient needs.

Those randomized to EN will have a feeding tube placed and started on tube feeds via a designated pump for overnight feeds, meeting at least 50% of estimated energy needs to allow for continued regular dietary intakes during the day.

Those receiving age-appropriate appetite stimulants will be provided either cyproheptadine or dronabinol. Subjects will be given cyproheptadine if they fall between the ages of 2-12 years of age and dronabinol if they are \>12 years of age or older.

8oz (240mL) per dose at least once a day, but up to six times per day depending on estimated nutrient needs. The formula will equate to 1.0kcal/mL

Oral Nutrition Supplement

EN will have a feeding tube placed and started on tube feeds via a designated pump for overnight feeds, meeting at least 50% of estimated energy needs

Tube Feed

0.25mg/kg/d divided BID. May titrate by 4mg increments to a max of 12mg/day.

5mg BID (before breakfast and lunch). May titrate by 2.5mg increments to max of 20mg/day

Diet education on high protein, high calorie food consumption

Standard of Care

Corey J Hawes, DCN, RD, CSO, CNSC, LD

Amanda M Harrington, MD

Kelly Zavitz, PharmD, BCPPS

Nearly 60% of pediatric patients diagnosed with cancer develop malnutrition caused by a combination of disease burden, side effects of chemotherapy, and the intensity of cancer treatment. These patients are known to have an increased risk of infection, treatment-related toxicity, inferior clinical outcomes, and increased risk of mortality. Malnutrition may progress to cancer cachexia, characterized by anorexia, increased inflammation, decreased fat, and decreased muscle mass with subsequent weight loss, which is associated with decreased overall survival.

The goal of the proposed research is to determine changes in body composition, weight status, and nutritional status between common nutrition interventions including oral nutrition supplements (ONS), appetite stimulants, and enteral nutrition (EN) among pediatric cancer patients. A secondary goal of this research is to utilize the findings to develop clinical nutrition guidelines for this patient population. The specific objective of the research proposed is to solve the lack of evidence to adequately treat nutritional deficits in the pediatric oncology population. Without this data, there is a lack of clinical consistency in the initiation and selection of appropriate nutrition interventions to provide a more definitive pathway of care. This study can help formulate a clinical guideline for this patient population before, during, and after treatment.

The investigators plan to enroll a minimum of 45 subjects between the ages of 2-18 years old, over the course of one year, including males and females of all ethnicities. The subject will be a newly diagnosed pediatric patient with cancer who will actively receive chemotherapy at UK Healthcare's Kentucky Children's Hospital (KCH).

All those who enroll will have a baseline ultrasound and biomarkers taken at enrollment. Participants will also receive 'standard of care' medical nutrition therapy (MNT) counseling at diagnosis for following a high protein/high-calorie diet. If any of the enrolled participants lose \>10% of the diagnosis weight, the participants will then be randomized to receive (1) oral nutrition supplements, (2) age-appropriate appetite stimulants, or (3) enteral nutrition via a feeding tube. At the point of randomization, participants will receive another ultrasound and biomarkers. Those randomized will then receive additional ultrasounds and biomarkers at 1 month and 3 months after randomization. The remaining patients that have either weight maintenance or weight gain, will be utilized as a comparator group and will receive an ultrasound at 3 months and 6 months from enrollment/diagnosis. Each group will have a goal of at least 10 patients per group.

Those receiving ONS will be prescribed a standard ONS (1.0 kcal per mL) that will meet a minimum of 50% of estimated energy needs to promote weight gain but allow for continued regular dietary intakes. The ONS will be prescribed as 8oz (240mL) per dose at least once a day, but up to six times per day depending on estimated nutrient needs. Those receiving age-appropriate appetite stimulants will be provided either cyproheptadine or dronabinol. Subjects will be given cyproheptadine if the participants fall between the ages of 2-12 years of age and dronabinol if the participants are \>12 years of age or older. Table 1 summarizes the medication dosage forms, initial and dose titration options, and precautions/contraindications of each appetite stimulant. Medication adjustments will be made within 2-4 weeks of initiation due to the variable peak effect times, and chemotherapy treatment plans dictating clinic follow-up. Those randomized to EN will have a feeding tube placed and started on tube feeds via a designated pump for overnight feeds, meeting at least 50% of estimated energy needs to allow for continued regular dietary intakes during the day. After placement of a feeding tube, an abdominal x-ray will be obtained per hospital policy to confirm the appropriate placement of the feeding tube prior to use to ensure the safety of using said feeding tube.

Baseline demographics will be collected, including gender, age, diagnosis, QMLT ultrasound measurement, subjective global assessment (SGA) malnutrition risk, pediatric z-scores, and activity levels. Investigators will assess the subjects' nutritional intake, body composition via QMLT ultrasound, mid-upper arm circumference, pediatric z-scores (weight, length, and body mass index), biomarkers (leptin, IL-6, Lipid profiles, Cystatin-C, Vitamin D, and C-reactive protein), compliance and tolerance to nutrition intervention, physical activity, and clinical outcomes (rates of infection, number of hospital days for non-chemotherapy administration, number of clinic visits for non-chemotherapy administration, chemotherapy toxicity CTCAE grade, rate or relapse, and 1-year survival rates) at multiple time points throughout the study. Nutritional assessment will involve a 24-hour food recall which will be performed at diagnosis, randomization, and then every 1-2 weeks once randomized to an intervention. Weight loss and pediatric z-scores (weight-for-age, length-for-age, and BMI-for-age) will be assessed every 1-2 weeks throughout the study enrollment. Ultrasound assessment will be of the QMLT by measuring at the midpoint between the ASIS and the upper pole of the patella. The measurements will be taken bilaterally, three times, and averaged together for the final measurement. Ultrasound assessment will occur at enrollment when weight loss criteria are met for randomization, and then at 1 month and 3 months after randomization (or when the weight lost is regained).

Pediatric physical activity will be assessed every 1-2 weeks in combination with ultrasound measurements. Adherence and adverse effects to medications, tube feeds, or oral nutrition supplements will be assessed at each clinic visit. Biomarkers will be analyzed at randomization, 1 month, and 3 months after randomization. Standard of care for patients are to receive MNT education at diagnosis. For those that lose weight, standard of care is to receive the nutrition interventions listed above (oral nutrition supplements, appetite stimulants, or enteral nutrition via feeding tube). The standard of care is to generally go from a least invasive to a more invasive approach. The research components of this study include being randomized to a nutrition intervention rather than a non-validated step-wise approach, the ultrasound measurements, and the biomarkers. These components are not considered standard of care and are research procedures. Baseline demographics will be collected, including gender, age, diagnosis, QMLT ultrasound measurement, subjective global assessment (SGA) malnutrition risk, pediatric z-scores, and activity levels. The team will assess the subjects' nutritional intake, body composition via QMLT ultrasound, mid-upper arm circumference, pediatric z-scores (weight, length, and body mass index), biomarkers (leptin, IL-6, Lipid profiles, Cystatin-C, Vitamin D, and C-reactive protein), compliance and tolerance to nutrition intervention, physical activity, and clinical outcomes (rates of infection, number of hospital days for non-chemotherapy administration, number of clinic visits for non-chemotherapy administration, chemotherapy toxicity CTCAE grade, rate or relapse, and 1-year survival rates) at multiple timepoints throughout the study. Nutritional assessment will involve a 24-hour food recall which will be performed at diagnosis, randomization, and then every 1-2 weeks once randomized to an intervention. Weight loss and pediatric z-scores (weight-for-age, length-for-age, and BMI-for-age) will be assessed every 1-2 weeks throughout the study enrollment. Ultrasound assessment will be of the QMLT by measuring at the midpoint between the ASIS and the upper pole of the patella, a total of 4 ultrasounds will be conducted during the study. The measurements will be taken bilaterally, three times, and averaged together for the final measurement. Ultrasound assessment will occur at enrollment when weight loss criteria are met for randomization, and then every 1-2 weeks for up to 8 weeks after randomization. Pediatric physical activity will be assessed every 1-2 weeks in combination with ultrasound measurements. Adherence and adverse effects to medications, tube feeds, or oral nutrition supplements will be assessed at each clinic visit.

Biomarkers will be analyzed at randomization, and weeks 4 and 8 after randomization. Additionally, measurements of resource utilization will be measured such as the number of hospital days for non-chemotherapy-related problems, the number of sick visits to the clinic, dietitian visits, infections, and rates of relapse or overall survival. Biomarkers will be drawn when the children are in the clinic for chemotherapy or lab work. The participants will already have their central venous line accessed by a qualified clinic RN and labs will be drawn at that time to ensure no extra harm to the patient. Additionally, all patients will have EMLA cream used to numb the area prior to having a clinic RN who is trained in accessing ports and has accessed the ports during previous clinic visits and will continue to do so throughout therapy.

Pediatric Oncology Nutrition Intervention Trial

The Pediatric Oncology Interventional Nutrition Therapy (POINT) Trial: A Pilot Study

Change in body composition will be measured by ultrasound of the quadricep muscle layer thickness in millimeters.

Change in body composition will be measured by mid-upper arm circumference via z-scores by measuring the mid-upper arm in centimeters and comparing to CDC standards.

These will be measured by CTCAEs to determine grade toxicity from interventions.

This will be measured with weight in kilograms and will be combined with data from CDC standardized growth charts to provide the weight z-score.

This will be measured with pediatric z-scores for BMI and weight/length z-scores. Weight in kilograms and height in cm will be combined to report BMI in kg/m\^2 and then plotted on CDC growth charts for z-scores.

These biomarkers will be measured via central venous lines, including IL-6 (pg/mL)

These biomarkers will be measured via central venous lines, including leptin (ng/mL) and vitamin D (ng/mL).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of WB-EMS and Specific Dietary Supplements on Cancer Patients	NCT03151291	Cancer Cancer Cachexia Weight Loss Muscle Loss Muscle Weakness	β-hydroxy-β-met... L-carnitine (LC... Eicosapentaenoi... Whole-Body Elec...	18 Years -	University of Erlangen-Nürnberg Medical School
GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer	NCT05088304	Cancer of Stoma... Cancer of Esoph... Malnutrition Muscle Loss	no intervention	18 Years -	Jinling Hospital, China
Functional Muscle Transfers in Lower Limb Sarcoma: 3D Gait Analysis and Environmental Simulation	NCT04911972	Sarcoma Muscle Tumor Muscle Loss	Functional musc...	18 Years - 95 Years	NHS Greater Glasgow and Clyde
GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer	NCT05088304	Cancer of Stoma... Cancer of Esoph... Malnutrition Muscle Loss	no intervention	18 Years -	Jinling Hospital, China
Effects of WB-EMS and Dietetic Treatment on Cancer Patients	NCT02293239	Cancer Cancer Cachexia Weight Loss Muscle Loss Muscle Weakness	Whole-Body Elec...	18 Years -	University of Erlangen-Nürnberg Medical School
Effects of WB-EMS and Dietetic Treatment on Cancer Patients	NCT02293239	Cancer Cancer Cachexia Weight Loss Muscle Loss Muscle Weakness	Whole-Body Elec...	18 Years -	University of Erlangen-Nürnberg Medical School
The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease	NCT05215964	Polycystic Kidn... Polycystic Live... Muscle Loss	Renal artery em...	20 Years -	National Taiwan University Hospital
GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer	NCT05088304	Cancer of Stoma... Cancer of Esoph... Malnutrition Muscle Loss	no intervention	18 Years -	Jinling Hospital, China
Effects of Creatine Supplementation in Breast Cancer Survivors	NCT04207359	Breast Cancer Chemotherapy Ef... Muscle Weakness Muscle Loss Exercise	Creatine	18 Years - 75 Years	The University of Texas Health Science Center at San Antonio
Pediatric Oncology Nutrition Intervention Trial	NCT06175273	Pediatric Cance... Nutrition Relat... Nutrition Aspec... Muscle Loss Malnutrition, C...	Oral Nutrition ... Tube Feed Cyproheptadine Dronabinol Standard of Car...	2 Years - 19 Years	University of Kentucky

Spots Global Cancer Trial Database for muscle loss

Every month we try and update this database with for muscle loss cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for muscle loss

Every month we try and update this database with for muscle loss cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for muscle loss cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.