Use of a Medical Food in Adults Undergoing Surgery (NCT04041908) | Clinical Trial Compass
TerminatedNot Applicable
Use of a Medical Food in Adults Undergoing Surgery
Stopped: Low enrollment
United States1 participantsStarted 2020-03-13
Plain-language summary
Multi-center, prospective, one arm study to evaluate the addition of a medical food to the standard of care in elderly adults undergoing a surgical procedure.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is scheduled to have non-melanoma skin cancer on either the head, leg, trunk and arm removed with final wound size of 1.0 to \< 5.0 cm in diameter or with 1.0 \< 5.0 cm long axis if not circular that will be healed by secondary intent
* Participant has an acceptable state of health and nutrition
* Participant agrees not to begin taking any new medications, dietary supplements, or alternative therapies during the study period
* Participant is interested in participating in the study, willing to comply with the study protocol, and willing to consume two servings of drink mix per day according to the protocol
* Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability (HIPAA) authorization prior to any study participation
Exclusion Criteria:
* Participant has a disease or condition that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the participant with study visits/procedures
* Participant has type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
* Participant has known immunosuppression
* Participant has platelet or coagulation disorders
* Therapy with another investigational agent within 30 days of Visit 1 that has not been approved
* Systemic infection at the time of enrollment in the study
* Currently receiving or h…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.