Neoadjuvant FOLFOX Chemotherapy for Colon Cancer: Long-Term Chemotherapy-Induced Peripheral Neuropathy and Impact on Quality of Life
Russia54 participantsStarted 2021-03-19
Plain-language summary
The goal of this observational study was to learn about the long-term effects of neoadjuvant (pre-surgery) chemotherapy on patients with locally advanced colon cancer. The main focus was to better understand the severity of long-lasting nerve damage, known as chemotherapy-induced peripheral neuropathy (CIPN), and its impact on patients' quality of life (QoL).
The key question the study aimed to answer was: What is the long-term severity of this common adverse event, and how much of an impact does it have on patients' quality of life?
Participants provided detailed responses about the severity of their CIPN symptoms and the overall impact on their well-being using the FACT-GOG-Ntx questionnaire.
Who can participate
Age range
18 Years – 80 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.
Exclusion criteria
. Cured non-melanoma skin cancer without known signs of recurrence or progression for \> 5 years.
. Cured carcinoma in situ without signs of recurrence or progression for \> 5 years.
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
Severity of long-term chemotherapy-induced peripheral neuropathy
Timeframe: At least 3 months after the end of platinum-containing treatment
2
Patients' quality of life
Timeframe: At least 3 months after the end of platinum-containing treatment
Trial details
NCT IDNCT06844409
SponsorP. Herzen Moscow Oncology Research Institute