Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Adult and elderly patients with age 18 to 80 (both inclusive) of both sexes with newly diagnosed locally advanced/metastatic cancer. Evidence of cachexia as judged by one of: a) More than equal to 5 percent of documented weight loss in the previous 6 months. b) A subjective report of weight loss in the previous 6 months and a recorded BMI less than 20 kilograms per square meter. Greater than or equal to 2 percent coupled with a BMI of less than 20 kg per square meter. c) Ongoing documented weight loss of at least 1 kg in the week before day 0, or 1.5 kg in the 3 to 6 weeks before day 0; provided that BMI is not more than 25 kilograms per square meter. Evidence of pre-cachexia/no-cachexia as judged by: a) Cancer patients with less than or equal to 5 percent body weight loss. No previous or current mental illness or disturbance of consciousness. Patients willing to provide informed consent. For healthy volunteers: 1) Adult and elderly healthy individuals of with age 18 to 80 (both inclusive) of both sexes who are self-reported to be healthy. 2) The subject is willing to participate and to provide an informed consent form. 3) Subjects who have no history of psychological disorder within the last five years.
Exclusion criteria
Exclusion criteria: Exclusion criteria for healthy volunteers: 1) Participants having a history of alcohol consumption/abuse, drug abuse, regular smoking. and tobacco chewing. 2) Pregnant or lactating women. 3) Participation in another clinical trial within 30 days before study inclusion. 4) Subjects may not have major medical or other conditions that might affect the study assays: major surgery or trauma in the past six months, diabetes, history of coagulation abnormalities, history of clinically significant neurologic, endocrine, pulmonary, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders, artificial nutrition, major walking handicap. 5) Participants not ready to provide written informed consent. 6) History of cognitive impairment, and stroke 7) Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 8) Participants diagnosed with HIV. 9) Subjects who have donated blood for 360 ml or more within three months before the screening. Exclusion criteria for pre-cachexia/no cachexia & cachexia group same as above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome 1: Body mass and body composition parameters Outcome 2: Performance tests Outcome 3: Inflammatory markers Outcome 4: Markers of carbohydrate metabolism Outcome 5: Markers of lipid metabolism Outcome 6: Skeletal muscle wasting parametersTimepoint: Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome 1: Adverse events Outcome 2: Quality of life Outcome 3: Cancer derived exosomes and their active micro-RNATimepoint: Baseline | — |
Countries
India
Contacts
Public ContactDr Bhoomika Patel
National Forensic Sciences University
Outcome results
None listed