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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT03574194
Eligibility Criteria:
Inclusion Criteria:
* Men and women over age 18
* Any non-skin cancer malignancy to be treated with standard of care, curative-intent, radiation therapy with an RT course of 6 weeks or less, without concurrently administered cytotoxic chemotherapy. Patients with oligometastatic disease being treated with local consolidative radiation therapy are also eligible. Pathologic confirmation of malignancy is not required if the treating physician(s) agree that this lesion is highly likely to be malignant and the patient elects to forego biopsy.
* The RT plan must achieve standard normal tissue dose-volume constraints.
* Zubrod Performance status 0-2
* Adequate organ and marrow function (leukocytes ≥ 2,000/μL, platelets ≥ 50,000/μL, hemoglobin \> 8.0 g/dL, total bilirubin ≤ 3 X ULN, AST(SGOT)/ALT(SPGT) ≤ 3 X ULN, albumin \> 2.0 g/dL, calcium \< 10.5 mg/dL, creatinine ≤ 3 X ULN)
* Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
* Women of childbearing potential and male participants must agree to use a medically effective means of birth control, such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills, throughout their participation in the treatment phase of the study.
* Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
* Prior radiation therapy that would result in overlap of radiation fields.
* Unintentional weight loss of \>10% of normal body weight over a period of 6 months or less.
* Use of an appetite stimulant in the past 6 months for unintentional weight loss.
* Allergy to soy (an ingredient in both methionine-free medical food supplements).
* Administration of cytotoxic chemotherapy within 4 weeks prior to initiation of the study treatment.
* Use of ongoing biologic/targeted/immune/hormonal therapy will be permitted.
* There should be no intention for the patient to receive other local therapy (radiotherapy and/or surgery) or cytotoxic chemotherapy within 4 weeks after completion of the study treatment
* Active systemic, pulmonary, or pericardial infection.
* Psychiatric illness/social situations that would limit compliance with study requirements. \* - Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03574194
Study Brief:
Protocol Section:
NCT03574194