Chemotherapy-related Toxicity, Nutritional Status and Quality of Life (NCT02848807) | Clinical Trial Compass
UnknownNot Applicable
Chemotherapy-related Toxicity, Nutritional Status and Quality of Life
Poland100 participantsStarted 2014-09
Plain-language summary
Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.
Who can participate
Age range
18 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:
* histological confirmed diagnosis of CRC in clinical stage IV
* successful qualification to chemotherapy
* performance status at least 80% according to Karnofsky scale and \<2 according to WHO/ECOG scale
* cancer-related asymptomatic precachexia diagnosed
* absence of contraindications to oral nutrition and practicable realization of oral nutrition
* absence of severe, decompensated concomitant diseases
* signed informed consent for the participation in the study
Exclusion Criteria:
* diagnosis of a malignant neoplasm in clinical stage I-III
* disqualification from oncologic treatment
* cancer cachexia or cancer anorexia-cachexia syndrome
* poor performance status
* contraindications to oral nutrition or to high protein nutrition
* regular nutritional support at the moment of qualification to the study
* patient incompliance at the moment of qualification to the study
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.
What they're measuring
1
Chemotherapy-related toxicity during 12th week of observation