Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT06128694
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed lung and ob-gyn cancer patients (who have not undergone therapy or are currently undergoing therapy)
* Aged greater than or equal to 18 years
* Patients with a performance status score of 0 - 2
* Have inadequate food intake \>5 days or:
1. BMI/body mass index \<18.5 kg/m2 or
2. There is a \>10% weight loss in the last 3-6 months or
3. BMI \<20 kg/m2 or
4. There is \>5% weight loss in the last 3-6 months with
* Intervention group subjects are willing to take ONS orally for 8 weeks
* Intervention group subjects, if they have taken other brands of ONS, are willing to stop taking ONS 2 weeks prior to the study.
Exclusion Criteria:
* Pregnant and breastfeeding, except for female subjects with one of the following criteria:
1. Have a history of hysterectomy (surgical removal of the uterus) and/or bilateral oophorectomy (surgical removal of the ovaries).
2. Medically confirmed ovarian failure (decreased ovarian function)
3. Achieved post menopausal status, defined as: cessation of regular menstruation for at least 12 consecutive months in the absence of pathological or physiological causes.
* Renal insufficiency (eGFR ( Estimated Glomerular Filtration Rate ) \<15 mL/min/1.73 m2 or significant increase in urea/creatinine or having to be on a low protein diet)
* Liver insufficiency (SGOT (Serum Glutamic Oxaloacetic Transaminase) /SGPT (Serum Glutamic Pyruvic Transaminase) values ≥3 times the normal limit)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06128694
Study Brief:
Protocol Section:
NCT06128694