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 range18 Years – 80 Years
SexFEMALE
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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…
What they're measuring
1
efficacy of telmisartan to prevent new onset of Paclitaxel- induced peripheral neuropathic pain (PIPNP)