Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Carcinoma, Non-Small-Cell Lung

Muscular Atrophy

Lung Neoplasms

Wasting Syndrome

Cachexia

Carcinoma

Atrophy

Syndrome

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Body Weight

Weight Loss

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

subjects will be randomized to receive GTx-024 3mg sofgel capsule once daily for the duration of the trial

subjects will be randomized to receive matching placebo once daily for the duration of the trial

subjects will be randomized to receive GTx-024 3mg softgel for the duration of the trial.

GTx-024

subject will receive matching placebo for the duration of the trial

placebo

The purpose of this study is to determine if the investigational drug GTx-024 can help patients with non small cell lung cancer increase physical function and maintain or gain muscle.

This is a randomized, double blind, placebo controlled, multicenter, multinational efficacy and safety study in subjects with non small cell lung cancer. Subjects will be evenly randomized to placebo or GTx-024 prior to initiation of first line chemotherapy. The primary efficacy analysis will be based on total Lean Body Mass (LBM) and physical function.

Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum

Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer on First Line Platinum Plus a Non-Taxane Chemotherapy

Measure is the percentage of subjects at day 84 with stair climb power change \>=10% from their baseline value.

Measure is the percentage of subjects at day 84 with lean body mass change \>=0% from their baseline value.

Initiation: 29 Nov 2011, Completion: 30 May 2013

subjects will be randomized to receive GTx-024 for the duration of the trial

GTx-024: subjects will be randomized to receive GTx-024 for the duration of the trial.

GTx-024 3mg Once Daily

subjects will be randomized to receive placebo for the duration of the trial

placebo: subject will receive placebo for the duration of the trial

Placebo Once Daily

subjects will be randomized to receive GTx-024 for the duration of the trail

GTx-024: subjects will be randomized to receive GTx-024 for the duration of the trial.

Placebo

Total

Age, Continuous

Sex: Female, Male

Subjects included in the Full Analysis Set

Senior Director, Clinical Operations

Physical Function

Lean Body Mass

subjects will be randomized to matching placebo once daily for the duration of the trial

placebo: subject will receive placebo for the duration of the trial

Overall Study

Antineoplastic Agents

All Drugs and Chemicals

Taxane

subject will receive GTx-024 treatment for the duration of the trial

subject will receive placebo for the duration of the trial

subjects will be randomized to receive GTx-024 for the full duration of the trial.

The purpose of this study is to determine if the investigational drug GTx-024 can help subjects with non-small cell lung cancer increase physical function and maintain or gain muscle, also called "lean body mass".

This is a randomized, double-blind, placebo controlled, multicenter, multinational efficacy and safety study in subjects with non small cell lung cancer (NSCLC). Subjects will be evenly randomized to placebo or GTx-024 prior to initiation of first line chemotherapy. The primary efficacy analysis will be based on total lean body mass and physical function.

Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)

Phase III, Randomized, Double-Blind, Placebo Controlled Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer on First Line Platinum Plus a Taxane Chemotherapy

Initiation: 26 Oct 2011, Completion: 8 May 2013

subject will receive GTx-024 treatment for the duration of the trial

GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.

subject will receive placebo for the duration of the trial

placebo: subject will receive placebo for the duration of the trial

Anorexia

Level 0: Ruxolitinib 0 MG po bid for 1 month (Month 1)

Level 1: Ruxolitinib 10 MG po bid for 1 month (Month 2)

Level 2: Ruxolitinib 15 MG po bid for 1 month (Month 3)

There will be intra-patient dose escalation of ruxolitinib in every patient enrolled on study.

Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients.

Sarah Neufeld

Tu Dan, MD

To assess toxicity with use of Ruxolitinib in NSCLC cachexia patients; to associate levels of JAK/STAT signaling in blood, adipose, and muscle pre- and post-ruxolitinib treatment with changes in cachexia and anorexia.

Lung cancer patients on a whole, and a significant percentage of NSCLC patients in particular, develop cancer cachexia. In fact, approximately 30-40% of all NSCLC patients will develop cachexia in their disease course, with the highest percentages in stage IV patients. One-third of these patients will die of cachexia-related morbidity. In these groups, stage-matched NSCLC patients with cachexia will have poorer survival than those without cachexia.

The JAK 1/2 inhibitor ruxolitinib has been used in many types of non-oncologic and oncologic patients with a well-established toxicity profile. Ruxolitinib was created as an oral agent with the capacity to antagonize JAK/STAT signaling across cell types. Based on the findings of the REACH2 and REACH3 trials, a starting dose of 10 mg twice daily oral administration of ruxolitinib was established for the latter patient population and is also a starting dose for the polycythemia patients. Known but manageable side effects of ruxolitinib use include thrombocytopenia, anemia, neutropenia, risk of infection, among other conditions.

Ruxolitinib has not specifically been used in 1) cancer cachexia patient populations in an evaluable trial or 2) in the setting of first line cancer therapies for solid tumors who are receiving new standards of care including immunotherapy (IO). Therefore, in this trial, investigators propose using ruxolitinib in an open-label approach to antagonize systemic and tissue-specific, tumor-directed JAK/STAT signaling as a means curtailing cachexia progression in stage IV NSCLC patients. This study will ensure an acceptable toxicity profile when ruxolitinib is used in cancer cachexia patients.The use of ruxolitinib dose escalation in the same patients with frequent tissue and serum collections will permit us to better understand how important JAK/STAT signaling is to clinical cancer cachexia development.

Open label, single arm, pilot study, Intrapatient dose escalation

Ruxolitinib for Cancer Cachexia

Pilot Study of Ruxolitinib in the Treatment of Cancer Cachexia

To assess toxicity with use of Ruxolitinib in NSCLC (non-small cell lung cancer) cachexia patients; to associate levels of JAK/STAT (Janus kinase-signal transducer and activator of transcription) signaling in blood, adipose, and muscle pre- and post-ruxolitinib treatment with changes in cachexia and anorexia. NCI's CTCAE v5.0 toxicity criteria will be used to measure Ruxolitinib-related side effects. Immunoblotting, FACS analyses, and other biologic metrics will be used to determine if Ruxolitinib can suppress cachexia-associated JAK/STAT activation in blood and peripheral tissues.

For the secondary objective of adverse events, investigator will again use NCI's CTCAE v5.0 toxicity criteria throughout the trial evaluation.

Patient tumor response will be determined by CT-based imaging (CT, PET/CT), MRI (brain evaluation), and other clinical indicators (bronchoscopy, image-guided biopsies), etc. with RECIST and iRECIST criteria response criteria as a function of Ruxolitinib use and dose. In patients with measurable disease, to describe any preliminary evidence of Ruxolitinib's anti-tumor activity by assessment of objective response as determined by RECIST in cancer cachexia patients. Two such measurements will be conducted during the course of the trial.

Quality of life questionnaire while on ruxolitinib will be assessed with the EORTC QLQ-CAX24 (The European Organization for Research and Treatment of Cancer quality of life questionnaire). Questionnaire will be given to patients every 2 weeks for 3 months while on study and 1 month of follow-up.

Body weight will be measured every 2 weeks while on study, including 1 month of follow-up. Both DEXA (dual-energy x-ray absorptiometry) imaging every 2 weeks while on study/follow-up and CT-based imaging with auto-segmentation will provide measures of how Ruxolitinib may be suppressing cachexia-associated adipose and muscle loss.

Anorexia will be assessed with the EORTC QLQ-CAX24 questionnaire as well as direct clinical history taking every 2 weeks on study. Descriptive statistics will be used to report changes.

Progression-free survival (CT-based imaging) will be assessed for all patients while on and off Ruxolitinib. There will be one determination of OS at 6 months from start of active phase of study. Estimates will be descriptively presented using the Kaplan-Meier method.

Incyte Corporation

Tu Dan

Principal Investigator

Head and Neck Neoplasms

Hyperglycemia

Postoperative Complications

Glucose Metabolism Disorders

Anabolic Androgenic Steroids

Patients assigned to control group will not receive feeding via the nasogastric tube during operation

Patients assigned to intraoperative feeding group will receive enteral nutrition formula via the nasogastric tube during operation

Intervention group will receive nasogastric feeding with commercially available liquid enteral diet (250 ml/can, Kcal/ml, 10.4 g protein/can) during free flap reconstruction at feeding rates 10-30 ml/h.

Enteral nutrition formula

Chen-Fuh Lam, MD, PhD

Perioperative fasting remains a common clinical practice in surgical patients to prevent the development of postoperative anesthesia- and surgical-related complications. Clinical observational studies indicated that the combination catabolic effects resulted from prolonged perioperative fasting and profound surgical stress are likely to induce extensive protein catabolism, muscle breakdown and impaired glycemic control during postoperative phase, leading to the development of severe complications. Furthermore, prolonged gastrointestinal fasting is associated with microbial translocation that deteriorates the early recovery after surgery. This clinical trial anticipates in determining the beneficial effect of intraoperative feeding to improve intraoperative hemodynamics and enhance postoperative recovery due to attenuation of systemic catabolism and improvement of insulin sensitivity to glycemic control.

Perioperative fasting remains a common clinical practice in surgical patients, aiming to prevent pulmonary aspiration during anesthesia induction, improve bowel preparation, and ameliorate the development of postoperative nausea/vomiting or other surgical-related complications. Major head-and-neck tumor excision and reconstruction surgery is one of the most time-consuming surgeries that usually takes more than 12 h to complete. In addition to the preoperative fasting and postoperative recovery time periods, most of these patients will be fasted for more than 24-36 h before they are fed via nasogastric tubes in the postoperative care units. The combination catabolic effects resulted from prolonged perioperative fasting and profound surgical stress are likely to induce extensive protein catabolism, muscle breakdown and impaired glycemic control during postoperative phase. These catabolic responses may lead to the development of post-operative surgical site infection, delayed wound healing, re-intervention, cardiac arrest, and death in diabetic and non-diabetic patients. Furthermore, prolonged gastrointestinal fasting is associated with dehydration, perturbed gut integrity/permeability (leaky gut) and microbial (bacterial) translocation that deteriorates the early recovery after reconstruction surgery. The aim of this clinical trial is to test the effect of intraoperative feeding in patients receiving head-and-neck tumor excision and reconstruction surgery, and anticipate that reduction of perioperative fasting time may improve intraoperative hemodynamics and enhance postoperative recovery due to attenuation of systemic catabolism and improvement of insulin sensitivity to glycemic control.

This single-center clinical trial will be undertaken in a randomized, double-blind, placebo-controlled fashion, in which patients with advanced head-and-neck tumor who are scheduled for extended tumor resection and free-flap reconstruction will be randomly assigned to receive control (no intraoperative feeding) or intraoperative feeding group. Feeding via the nasogastric (NG) tube will start after the establishment of tracheostomy and completion of tumor resection at fusion rate of 10-30 ml/h (feeding diet 1 Kcal/ml and 0.04 g protein/ml). This trial anticipates in detecting differences in intraoperative hemodynamic stability and development of major postoperative complications, including delayed wound healing, surgical site infections and insulin-resistant hyperglycemia between controls and intraoperative feeding group. The outcomes of this clinical trial may provide fundamental evidence for vigorous enteric nutrition and energy support during prolonged high surgical stress operation.

Participants: patients will receive general anesthesia before intervention Care providers: surgeons will be masked of the treatment group during operation

Anabolic Effects of Intraoperative Feeding in Reconstruction Surgery

A Randomized Trial of Intraoperative Feeding to Ameliorate Catabolic Response in Free Flap Reconstruction Surgery for Head-and-neck Cancer Defect

The definition of flap failure includes vascular occlusion of flap, surgical wound infection or poor healing that requires surgical reintervention

The definition of composite perioperative complications during and after operation, include intraoperative hemodynamic stability (hypotension and requirement of inotropes), postoperative insulin sensitivity, glycemic control, skeletal muscle wasting, inflammatory cytokine profiles, length of hospital stay, re-intervention, other postoperative complications, mortality during hospital stay

E-DA Hospital

Superintendent, professor

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Breast Neoplasms

Lymphoma

Leukemia

Leukemia, Lymphoid

Lymphosarcoma

The purpose of this study is to assess if Gtx-024 is effective in increasing lean body mass in subjects with muscle wasting related to cancer.

Cancer cachexia is characterized by a hypermetabolic state that leads to catabolism that is responsible for reductions in lean mass.These catabolic changes are accompanied by an increase in total energy expenditure, but a decrease in voluntary energy expenditure that ultimately results clinically in cachexia and its symptoms of lethargy, fatigue, weakness and general malaise (Kotler DP. Cachexia. Ann Intern Med. 2000; 133:622-634).

The prevalence of cachexia increases from 50 percent at presentation to more than 80 percent before death from malignancy. In over 20 percent of cancer patients, cachexia is the cause of death (Bruera E. Anorexia, cachexia and nutrition. Br Med J 1997;315:1219-1222). Cancer cachexia leads to shorter survival, decreased response rates and increased toxicity to chemotherapy, weakness, and an overall decreased quality of life (DeWys et al. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7). The purpose of this study is to assess the efficacy of GTx-024 on total body lean mass. Secondary endpoints include but are not limited to assessment of GTx-024 on muscle function, total body weight and total body fat mass.

Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.

Double-Blind, Placebo-Controlled, Dose-Finding Study of the Effect of GTx-024 on Muscle Wasting (Cachexia) in Patients With Cancer

Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.

Change in stair climb power from baseline to 4 months. Stair climb power is defined power (watts)=\[9.8 m/sec\*\*2\]\*\[weight (kg)\]\*\[height of 12 steps(meters)\]/ \[time (seconds) up the 12 steps\].

GTx -024

3 mg of Placebo

Age, Categorical

United States

Argentina

Region of Enrollment

GTx-024 1 mg

GTx-024 3 mg

The number of participants were those subjects in the modified intent-to-treat population (defined as subjects with at least one post baseline DEXA for LBM) who had baseline and 4 month DEXA results for LBM (observed cases).

The Efficacy of GTx-024 on Total Body Lean Mass.

The subjects were in the MITT population (had a post baseline DEXA) and had a month 4 stair climb assessment (observed cases).

To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb.

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

asymmetric biphasic waveforms at 71 pulses per second frequency (Hz), 400 s pulse duration, 5:10s on:off time (50% duty cycle), and 1.5s ramp-up time. Participants will be in control of the muscle stimulator devices at all times and will be instructed to perform all sessions in the supine position. Bilateral NMES will be delivered via asymmetric, biphasic using four cutaneous parallel channels delivered simultaneously using 2"x4" or 3"x5" self-adhesive electrodes. For the active NMES group, participants will be encouraged to increase the amplitude to a level of moderate discomfort, such as that experienced during conventional exercise, but not to induce pain. At minimum, the amplitude should induce visible muscle contraction.

The amplitude of the muscle stimulators for the Sham group will be capped at 15 milliamperes so patients will only feel cutaneous sensation without achieving muscle contraction.

Active or Sham Neuromuscular electrical stimulation. US Food and Drug Administration-approved 2012

RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)

Lindsey J Anderson, PhD

Jose M Garcia, MD PhD

Some blood, bone marrow, and lymphatic (hematologic) cancers such as Hodgkin/Non-Hodgkin lymphomas, chronic lymphocytic leukemia, and multiple myeloma, are over-represented in Veterans due to exposures including Agent Orange and an increased percentage of patients of African American ethnicity. Hematologic transplantation (HCT) is a common treatment for these cancers, but often leads to deconditioning, fatigue, muscle atrophy, and poor quality of life, which are associated with complications such as hospitalization and infection. Despite the significance of these symptoms, there are no approved treatments to prevent/reverse these long-term effects. The cancer itself, side effects of chemotherapy, and sedentary behavior, contribute to these effects. Although exercise before and after HCT has helped reduce these effects, it is inconsistently recommended to patients and most remain sedentary through and after treatment. The investigators are testing an alternative exercise strategy, neuromuscular electrical stimulation, to maintain physical function quality of life after HCT.

Hematopoietic cell transplantation (HCT) reduces physical function and muscle mass and increases fatigue. Neuromuscular electrical stimulation (NMES), when used as a stand-alone intervention, improves muscle strength and muscle mass in non-cancer patients with chronic obstructive pulmonary disease and chronic heart failure. The use of NMES to combat disuse atrophy and functional decline may be particularly useful in the HCT setting as patients undergo intensive preparatory chemotherapy and often experience symptoms including severe fatigue that leave them inactive or isolated for extended time periods surrounding the transplant. However, its use in the setting of cancer has not been well-established. This proposal will contribute to developing strategies toward optimizing the safety and outcomes associated with HCT in Veterans with hematologic malignancies. The overall goals of this study are to assess 1) the efficacy of an NMES vs Sham intervention on HCT-induced reductions in physical function and muscle mass and worsening of patient-reported fatigue and QOL and 2) the association between physical function and prolonged recovery of patient-reported fatigue and QOL. The investigators hypothesize that 1) NMES will attenuate the acute HCT-induced negative impact on physical function, body composition, QOL, and fatigue compared to Sham intervention, and 2) baseline physical function will be a significant predictor of 6-month recovery of patient-reported fatigue and QOL. Aim 1: To determine the efficacy of NMES vs. Sham for attenuation of HCT-induced reductions in physical function, muscle mass, and patient-reported QOL and fatigue in patients undergoing autologous HCT. Patients will be randomized 1:1 (NMES:Sham) stratified by diagnosis. Physical function, body composition, QOL, and fatigue will be assessed at baseline (Pre, after admission to the Bone Marrow Transplant Unit but before initiation of preparatory chemotherapy) and 28 plus or minus 5 days after HCT (Follow-up 1; FU1). The primary outcome will be between-group difference in 6MWT change at FU1 compared to Pre (N=23/group; 46 total). Secondary outcomes include: body composition measured by dual-energy x-ray absorptiometry; previously validated questionnaires (Functional Assessment of Chronic Illness Therapy-Fatigue; Muscle and Joint Measures) to assess patient-reported fatigue, QOL, symptom burden, and functional status; standard of care clinical/laboratory data regarding co-morbidities, adverse events, hospitalizations, treatment history, functional status, and clinical course; and NMES process measures such as feasibility, acceptability, adherence in number of sessions, accurate use, duration/intensity, complications, and satisfaction. Aim 2: To determine predictive ability of baseline 6MWT on delayed recovery of physical function, QOL, and fatigue, patient-reported outcomes, physical function, and chart review will be collected 6-months after HCT (FU2). 6MWT at Pre will be used to determine significant predictors of QOL and fatigue at FU2 (N=46) as assessed by previously validated questionnaires. Clinical measures extracted from medical charts will include changes from FU1 to FU2 in standard of care clinical/laboratory data regarding co-morbidities, adverse events, hospitalizations, functional status, treatment history, disease trajectory, and survival. Aim 3 (exploratory): To investigate the acute impact of NMES vs. Sham during HCT on various aspects of physical function and patient-reported QOL for determining potential endpoints for future clinical trials. Exploratory measures of function (stair climbing power; muscle strength; sit-to-stand; handgrip strength; peak oxygen consumption) assessed at Pre and FU1 will be used to determine significant predictors of exploratory QOL measures (Multidimensional Fatigue Inventory; Short Form-36; European Organization for Research and Treatment of Cancer QOL Questionnaire) assessed at FU2.

Neuromuscular electrical stimulation (active vs sham signal)

During Informed Consent, patients will be instructed to not presume group assignment. An unblinded study coordinator will then randomize each participant to NMES:Sham on a 1:1 basis, stratifying by diagnosis. The unblinded coordinator will ensure each participant performs the appropriate NMES or Sham stimulus on each training day; stimulation will only occur in private exam rooms. NMES and Sham stimulators will be outwardly identical apart from a concealed "A" or "B" label indicating NMES or Sham device; the designation of A or B will only be known to the unblinded study coordinator, and not to the PI. The PI will administer all outcome assessments and conduct all statistical analyses; therefore the PI will remain blinded to NMES vs Sham group assignment until study completion. In the study database, group assignment will be coded as A or B, the PI will not know the coding of A or B. A document containing the coding will be kept in a different electronic location than the study folder.

Muscle Stimulation for Physical Function During Stem Cell Transplant

Neuromuscular Electrical Stimulation for Physical Function Maintenance During Hematopoietic Stem Cell Transplantation

Anderson Symptom Assessment Scale (range 0-10 where 10 is maximum fatigue)

dual energy fan-beam x-ray absorptiometry; bioelectrical impedance

Number of sessions completed out of total sessions

VA Office of Research and Development

Digestive System Diseases

Gastrointestinal Neoplasms

Hodgkin Disease

Digestive System Neoplasms

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Gastrointestinal Diseases

Hodgkin Lymphoma

Anti-Infective Agents

Respiratory System Agents

Acetylcysteine

N-monoacetylcystine

Antioxidants

Antiviral Agents

Expectorants

Protective Agents

Antidotes

N-acetylcysteine

Wulf Hildebrandt, MD

The purpose of the study is to tests the hypothesis, that N-acetylcysteine (a thiol-antioxidant)improves the exercise training effect on cancer patients that experience weight loss (cachexia) as assessed by muscle mass and function as well as histomorphology.

Effect of an Antioxidant on Cancer-Cachectic Patients Undergoing Exercise Training

Effect of N-Acetylcysteine on Skeletal Muscle in Cachectic Cancer Patients Undergoing a Resistance Training Program (Phase 2 Study)

Heidelberg University

German Cancer Research Center

Fluorodeoxyglucose F18

This arm includes 150 treatment-naive lung cancer patients. Assessments include medical history, physical exams, lab tests, and imaging. Objective: investigate cancer cachexia, stress, and metabolic changes. Cachexia criteria: weight loss, reduced food intake, inflammation markers. Stress assessment: questionnaires, biomarkers. Metabolic changes measured by PET-CT scans analyzing FDG uptake in organs/lesions. Data will uncover the relationship between cancer cachexia, stress, and metabolic changes in treatment-naive lung cancer patients, leading to improved interventions/outcomes.

A subgroup of patients from Vienna will undergo an additional PET/CT scan after the first follow-up PET/CT, which takes place one month after stress reduction training. The stress reduction training involves performing a breathing technique.

Stress Reduction Training

Marcus Hacker, Prof., MD

Josef Yu, MD

Andreas Bergthaler, Prof.

Osama Sabri, Prof.

Roberto Sciagra, Prof.

Marcus Hacker, Prof.

Thomas Beyer, Prof.

Roberto Sciagrà, Prof.

This prospective observational study aims to investigate the relationship between cancer cachexia, stress levels, and metabolic changes in 150 lung cancer patients. Cancer cachexia, characterized by weight loss and muscle wasting, significantly impacts patient outcomes. Psychological stress is thought to contribute to cachexia development. Assessments will include medical history, physical examinations, laboratory tests, and imaging. Cancer cachexia will be diagnosed based on weight loss, reduced food intake, and inflammation markers. Psychological stress will be evaluated using questionnaires and biomarkers. Metabolic changes will be assessed using positron emission tomography-computed tomography (PET-CT) scans. The primary objective is to determine differences in metabolic activity between cachectic and non-cachectic patients. Secondary objectives include evaluating changes in brain activity and exploring the relationship between stress, inflammation, and metabolism.

Title: Investigation of the Relationship Between Cancer Cachexia, Stress, and Metabolic Changes in Lung Cancer Patients

Background: Cancer cachexia is a debilitating syndrome characterized by progressive weight loss, muscle wasting, and metabolic abnormalities. It significantly impacts patients' quality of life and survival outcomes. Psychological stress has been suggested as a potential contributor to cachexia development and progression. This study aims to investigate the association between cancer cachexia, stress levels, and metabolic changes in lung cancer patients.

Methods: This multicenter, prospective observational study will enroll 150 lung cancer patients. Eligible participants will undergo comprehensive assessments, including medical history review, physical examinations, laboratory tests, and diagnostic imaging. Cancer cachexia will be diagnosed based on established criteria, including weight loss, reduced food intake, and systemic inflammation markers. Psychological stress will be evaluated using validated questionnaires and stress biomarkers. Metabolic changes will be assessed through positron emission tomography-computed tomography (PET-CT) scans to measure fluorodeoxyglucose (FDG) uptake in organs and lesions.

Primary Objectives: The primary objective is to determine differences in FDG uptake between cachectic and non-cachectic lung cancer patients in various organs and lesions. Secondary objectives include evaluating changes in amygdalar FDG uptake after stress intervention and exploring the relationship between stress, inflammatory markers, and metabolic changes.

Statistical Analysis: Student's t-test will be used to compare FDG uptake between groups, and descriptive statistics will be calculated for each brain region. Sample size calculations indicate a need for approximately 30 subjects per group to detect significant differences. Data will be analyzed using appropriate statistical software.

Ethical Considerations: Informed consent will be obtained from all participants, and the study will adhere to the principles outlined in the Declaration of Helsinki and Good Clinical Practice guidelines. The study protocol has been submitted to the Ethics Committee and regulatory authorities for approval.

Conclusion: This study aims to provide insights into the relationship between cancer cachexia, stress, and metabolic changes in lung cancer patients. By investigating FDG uptake in different organs and lesions, as well as amygdalar FDG uptake before and after stress intervention, this research may contribute to the development of targeted interventions for cachexia management and improve patient outcomes.

The overall model of this study involves enrolling a total of 150 patients from three different sites. These patients will undergo baseline PET/CT imaging to assess their metabolic changes, as well as provide clinical information through medical history review and physical examinations. Additionally, blood samples will be collected for laboratory tests, and patients will complete questionnaires to evaluate psychological stress levels. This comprehensive approach aims to gather a range of data including imaging, clinical information, blood biomarkers, and psychological assessments to investigate the relationship between cancer cachexia, stress, and metabolic changes in lung cancer patients.

Predicting Lung Cancer-Associated Cachexia With PET Imaging

The Role of 18F-FDG PET/CT in the Early Prediction of Cachexia in Lung Cancer Patients

Measurement of fluorodeoxyglucose (FDG) uptake in various organs and lesions to characterize the metabolic differences between cachectic and non-cachectic lung cancer patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum	NCT01355497	Muscle Wasting Non-Small Cell ...	GTx-024 placebo	30 Years -	GTx
Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)	NCT01355484	Muscle Wasting Non Small Cell ...	GTx-024 placebo	30 Years -	GTx
Ruxolitinib for Cancer Cachexia	NCT04906746	Stage IV Non-sm... Cachexia	Identify any do...	18 Years -	University of Texas Southwestern Medical Center
Ruxolitinib for Cancer Cachexia	NCT04906746	Stage IV Non-sm... Cachexia	Identify any do...	18 Years -	University of Texas Southwestern Medical Center
Anabolic Effects of Intraoperative Feeding in Reconstruction Surgery	NCT04266015	Fasting Feeding, Time R... Stress-related ... Head and Neck N... Catabolic State Hyperglycemia S... Muscle Wasting Complication,Po...	Enteral nutriti...	20 Years - 70 Years	E-DA Hospital
Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.	NCT00467844	Cachexia	GTx-024 GTx-024 Placebo	-	GTx
Muscle Stimulation for Physical Function During Stem Cell Transplant	NCT04364256	Autologous Hema...	RS-4i Plus Sequ...	18 Years -	VA Office of Research and Development
Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.	NCT00467844	Cachexia	GTx-024 GTx-024 Placebo	-	GTx
Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)	NCT01355484	Muscle Wasting Non Small Cell ...	GTx-024 placebo	30 Years -	GTx
Ruxolitinib for Cancer Cachexia	NCT04906746	Stage IV Non-sm... Cachexia	Identify any do...	18 Years -	University of Texas Southwestern Medical Center
Effect of an Antioxidant on Cancer-Cachectic Patients Undergoing Exercise Training	NCT00196885	Gastrointestina... Bronchial Carci... Hodgkin Disease Non-Hodgkin Lym... Weight Loss	N-acetylcystein...	20 Years - 80 Years	German Cancer Research Center
Predicting Lung Cancer-Associated Cachexia With PET Imaging	NCT05912465	Cachexia Lung Neoplasm	Stress Reductio...	18 Years -	Medical University of Vienna
Effect of an Antioxidant on Cancer-Cachectic Patients Undergoing Exercise Training	NCT00196885	Gastrointestina... Bronchial Carci... Hodgkin Disease Non-Hodgkin Lym... Weight Loss	N-acetylcystein...	20 Years - 80 Years	German Cancer Research Center

Spots Global Cancer Trial Database for muscle wasting