Prevention of Paclitaxel-induced Neuropathic Pain in Patients With Planned Paclitaxel Chemotherap… (NCT05322889) | Clinical Trial Compass
CompletedPhase 2
Prevention of Paclitaxel-induced Neuropathic Pain in Patients With Planned Paclitaxel Chemotherapy (PrevTel)
Germany35 participantsStarted 2020-04-09
Plain-language summary
Phase IIa clinical trial will be conducted with patients requiring in-label paclitaxel-chemotherapy due to ovarian or breast cancer. The efficacy of a 12-week telmisartan treatment, starting one week before planned paclitaxel-administration to prevent PIPNP (paclitaxel-induced peripheral neuropathic pain) will be assessed by measurement of occurrence of clinical symptoms of PIPNP as well as lipid profiles
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
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:
* Patients with a diagnosis of ovarian or breast cancer who are clinically eligible for paclitaxel therapy and for whom paclitaxel chemotherapy is planned (with use of standard treatment) in clinical routine care.
* Female patients ≥ 18 years and ≤ 80 years
* The patient must have completed radiotherapy or surgery for central nervous system (CNS) metastases \> 2 weeks prior to screening (SCR). Patients must be neurologically stable, having no new neurological deficits on clinical examination, and no new findings on CNS imaging as documented in clinical routine care. If patients require steroids for management of CNS metastases, they must have been on a stable dose of steroids for 2 weeks preceding SCR.
* Written informed consent obtained prior to the initiation of any protocol-required procedures
* Willingness to comply to study procedures and study protocol
Exclusion Criteria:
* Previously diagnosed or current peripheral neuropathic pain
* Other severe pain that might impair the assessment of neuropathic pain
* DN4 score ≥ 4
* Previous chemotherapy (incl. paclitaxel) within the last 5 years (treatment with cyclophosphamide and an anthracycline as part of an ongoing adjuvant or neo-adjuvant regimen is allowed)
* Current or planned combinational chemotherapy-regimens, e.g., with platinum-based drugs (Her2 antibodies are allowed; paclitaxel combination with trastuzumab +/- pertuzumab is allowed)
* All primary central nervous system (CNS) tumors or symptom…
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
efficacy of telmisartan to prevent new onset of Paclitaxel- induced peripheral neuropathic pain (PIPNP)