Cachexia

Locally advanced cervical cancer is a common cancer in women worldwide and often leads to serious nutritional problems like malnutrition and cachexia. This condition worsens during concurrent chemoradiotherapy (CCRT), especially due to treatments like platinum-based drugs, which cause muscle loss and weight loss, increasing mortality risk. Researchers are studying nanocrystalline megestrol acetate (MA), a drug that may help stimulate appetite and reduce inflammation, aiming to improve nutritional status and treatment outcomes in these patients. This clinical trial compares two groups of patients with locally advanced cervical cancer undergoing CCRT: one group will receive nanocrystalline megestrol acetate oral suspension at 625 mg daily for up to 8 weeks, and the other will receive CCRT alone. The nanocrystalline form of MA has better absorption and faster onset of effect than traditional forms, potentially leading to improved weight gain and reduced muscle wasting. The study will measure body mass index (BMI), appetite, lean body mass, treatment completion, and side effects related to radiotherapy. Participants will be monitored for changes in BMI during the 8-week treatment period, alongside assessments of appetite using a specific scale, survival rates, and inflammatory markers. Regular lab tests will evaluate organ function and safety. The trial will also track adverse events and quality of life. The total participation duration for each patient is up to 8 weeks of treatment, with ongoing assessments to understand the drug's impact on nutrition and cancer treatment tolerance.

Researchers are investigating early detection and risk assessment of hepatocellular carcinoma (HCC) in adults with advanced liver disease, specifically those with liver cirrhosis from various causes. This prospective multicenter study aims to compare ultrasound and abbreviated MRI (AMRI) as surveillance tools to assess their ability to detect HCC, as well as to study how body composition, such as fat and muscle levels, relates to disease progression and HCC risk. Participants with cirrhosis undergo regular clinical evaluations and imaging tests at set intervals, including ultrasound and abbreviated MRI scans. The study collects detailed data on body composition and tracks clinical outcomes like liver-related complications and mortality. These assessments occur over multiple visits, including baseline and follow-ups at 6, 12, and 18 months, with additional monitoring for up to 24 months to observe new cases of HCC and disease progression. During the study, participants receive structured exams, imaging, and body composition measurements at each visit. Researchers evaluate lesion risk for HCC using LI-RADS criteria and measure muscle mass through the Muscle Assessment Score. They also monitor liver stiffness and organ volumes at baseline and follow-up visits. The study's goal is to develop prediction models based on these clinical and imaging data to better understand HCC risk and liver disease progression over time.

Researchers are evaluating AV-380, an immunoglobulin G1 monoclonal antibody designed to bind human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia. This phase 1B open-label dose escalation study aims to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of AV-380 in cancer patients who have cachexia and elevated GDF-15 levels. Participants have metastatic solid tumors and are actively receiving standard of care chemotherapy. Participants receive AV-380 through intravenous infusion in ascending dose cohorts alongside their standard chemotherapy treatments. The study includes a dose escalation phase where the safety and appropriate dosage of AV-380 are evaluated. This phase allows researchers to monitor the effects of increasing doses of AV-380 over a study period of up to 4 months while patients continue their usual cancer therapies. During the study, participants will undergo assessments including monitoring for adverse events, toxicity, and laboratory abnormalities from enrollment until about 60 days after the last dose. Pharmacokinetic measures such as maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the curve (AUC) will also be evaluated. The total involvement includes regular evaluations to track safety, drug behavior in the body, and immune responses to AV-380.

Researchers are evaluating a multimodal artificial intelligence (AI) model for the early detection of cancer-associated cachexia in patients with pancreatic cancer. This observational study also aims to assess how feasible and acceptable diet and exercise interventions are for managing cachexia. The study will analyze both retrospective data from the Florida Pancreas Collaborative and prospective data from newly diagnosed patients at Moffitt Cancer Center. Participants include patients with newly diagnosed pancreatic adenocarcinoma at various stages, along with oncology clinicians involved in their care. The study involves baseline lifestyle and symptom assessments using dietary questionnaires, quality of life and symptom surveys, physical activity surveys, functional fitness tests, DEXA scans, and blood draws. Extended monitoring includes wearable devices such as Fitbit, diet and activity preference surveys at 9 months, and a one-time survey to assess the integration of diet and exercise into clinical practice. During the study, participants will complete surveys and wear activity monitors for up to 9 months to track quality of life, physical activity changes, and adherence to wearable devices. Researchers will evaluate the AI model's performance and survey completion rates. The study also monitors physical fitness and health status through tests and questionnaires to better understand cachexia management. This involvement helps gather comprehensive data on patient health and the practicality of lifestyle interventions in pancreatic cancer care.

This research aims to develop and test a modified minimally invasive surgical technique for sinus floor augmentation in patients with a residual bone height of 3 to 6 millimeters. The goal is to create a reliable implant bed of at least 10 millimeters in height after a healing period of 3 to 5 months. The study also seeks to reduce patient stress compared to traditional methods. Participants will undergo the sinus floor elevation procedure, which is being evaluated to improve outcomes and comfort. This surgical technique is studied on a pilot group of 12 patients, with no placebo or comparative treatments involved. The procedure targets the maxillary sinus area to enhance bone structure for dental implant placement. During the study, participants will be monitored to measure the height of bone augmentation after 4 to 5 months of healing. The research team will assess the surgical results and patient recovery, including any side effects or complications. The total duration includes the surgery followed by the healing and evaluation period to determine the procedure's effectiveness and patient impact.

Researchers are evaluating the safety, tolerability, how the body processes, and early effects of SXRN Injection in cancer patients suffering from anorexia-cachexia. This clinical trial has two phases: Phase Ia is a single-arm, open-label study with dose escalation, and Phase Ib extends the study by combining SXRN Injection with standard anti-tumor therapies in cancers like pancreatic cancer, non-small cell lung cancer, and colon cancer. The study is sponsored by Jiangsu Nutai Biologics Co., Ltd. and Jiangsu GQ Co., Ltd. In Phase Ia, participants receive one of 3 to 4 escalating doses of SXRN Injection (4 mg, 6 mg, 8 mg, or another dose), given intravenously once daily for 5 days followed by a 2-day break, forming a 3-week treatment cycle. Phase Ib includes two dose levels (6 mg and 8 mg) combined with standard anti-tumor treatment. Participants are enrolled sequentially by dose levels. The study plans to enroll 12-24 patients in Phase Ia and 20-30 in Phase Ib and is conducted at 1-2 centers nationwide. Participants will undergo various assessments including blood tests, physical function tests, weight and body composition measurements, questionnaires on appetite and quality of life, and tumor evaluations. Researchers will monitor side effects, drug levels in the body, and treatment responses up to 12 months or longer. The primary outcomes include maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose. Secondary measures involve changes in appetite, physical function, body weight, survival, and tumor response. Participants will be followed closely during and after treatment.

Researchers are evaluating the safety and tolerability of the SXRN Plasmid DNA Technique in patients with advanced solid tumors. This Phase I, open-label, dose-escalation study also investigates pharmacokinetics and preliminary efficacy. The study includes patients who have failed or cannot tolerate standard therapies or lack effective conventional treatments. Additionally, a continuous dosing exploration cohort will assess the safety and efficacy of Shuxinrui Na Injection in patients with cancer-related anorexia-cachexia using a randomized, double-blind, placebo-controlled design. The initial phase tests three doses of SXRN—2 mg, 4 mg, and 10 mg—given intravenously once daily for 5 days followed by 2 days off, in 3-week cycles. Dose adjustments depend on safety and pharmacokinetic results. The exploration cohort involves a 2-week period where patients receive placebo or 4 mg SXRN infusion daily, followed by 2 weeks of open-label 4 mg SXRN treatment for all participants. The study uses a triple-masked design with random assignment to groups. Participants will undergo regular assessments including monitoring of side effects, pharmacokinetics, appetite, physical function, body weight, and quality of life. Researchers will collect laboratory tests and imaging to evaluate tumor response and organ function. The primary outcomes include determining the maximum tolerated dose and effects on appetite and physical function over 12 months, with ongoing safety follow-up. Total participation duration varies based on treatment and follow-up requirements.

Researchers are evaluating the safety, tolerability, and how the body processes GFS202A in patients with advanced solid tumors who have pre-cachexia or cachexia. This phase I, open-label, multi-center study aims to find the highest safe dose and recommend a dosing range for future research. Participants have cancer-related weight loss and related appetite issues, making this study important for understanding potential treatments in this condition. Participants will receive GFS202A through intravenous infusion every three weeks in a 21-day cycle, for a total treatment duration of 12 weeks. The study includes multiple dose levels of GFS202A to assess safety and tolerability. During the treatment period, participants will be closely monitored for any side effects and pharmacokinetic responses. Throughout the study, participants will undergo various assessments including safety evaluations, collection of blood samples to measure drug levels and immune response, and biomarker analysis related to cachexia. Researchers will also monitor weight changes, muscle mass, and quality of life scores up to six weeks after the last dose. The trial includes follow-up for adverse events and dose-limiting toxicities to ensure participant safety over the study period.

This research aims to study muscle loss in patients with heart failure with reduced ejection fraction (HFrEF), a condition where the heart does not pump blood effectively. It focuses on severe muscle wasting and weight loss common in these patients. The trial will explore whether increasing dietary protein intake can help reverse muscle loss, and it also examines biological pathways like GDF-15 and ActRII that may drive this muscle wasting. Participants will be randomly assigned to one of three groups receiving different levels of protein supplementation using Ensure products by Abbott Nutrition. One group receives a high dose of 30 grams protein daily (Ensure Max Protein), another a low dose of 9 grams protein daily (Ensure Original), and the third group receives no supplementation. The intervention lasts for 6 months with monitoring at 3 and 6 months. During the study, participants will have their muscle mass measured in arms and legs (appendicular lean mass) at 3 and 6 months. Additional assessments include handgrip strength, walking ability with a 6-minute walk test, and physical performance tests. Researchers will monitor protein intake and evaluate safety throughout the trial, which is sponsored by Tufts Medical Center and runs up to 2027.

Researchers are evaluating the effects of a dietary supplement on blood-based nutritional biomarkers in healthy children aged 4 to 15 years. This pilot clinical study aims to gather preliminary data on how the supplement influences serum levels of vitamin D, vitamin B12, folate, omega-3 fatty acids, and other blood count parameters. The study is conducted by SF Research Institute, Inc. and focuses on understanding nutritional status through biomarker changes. The study involves a single group of participants who will take an investigational gummy dietary supplement called Kids Multi & Omegas. Children will be instructed to take two gummies once daily, with or without food, for a total of 4 weeks. Blood samples will be collected at the start and end of the study to assess changes in selected serum nutritional biomarkers. Participants will also undergo measurements of height, weight, and body mass index, and complete a socioeconomic questionnaire. Participants will attend two clinic visits: one for screening and baseline assessments and another at the end of the 4-week supplementation period. During the study, children or their caregivers will keep a daily diary recording supplement intake, medication use, and any side effects. Researchers will review compliance, collect blood samples, and assess changes in nutritional biomarkers and physical measurements. The total study duration for each participant is approximately 4 weeks.