Prevention of Paclitaxel-caused neuropathic pain by intake of Telmisartan in patients with planned Paclitaxel chemotherapy due to ovarian or breast cancer (PrevTel)
- Conditions
- patients with planned Paclitaxel chemotherapy due to ovarian or breast cancerMedDRA version: 20.0Level: LLTClassification code 10077974Term: Peripheral neuropathic painSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2019-000210-11-DE
- Lead Sponsor
- Fraunhofer Gesellschaft for its Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 35
• 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 CNS metastases > 2 weeks prior to 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
• 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 symptomatic CNS metastases that are neurologically unstable (Note: Only patients with controlled CNS metastases may participate in this trial)
• Previously reported intolerance to AT1-receptor-blockers
• Hypotension (blood pressure < 110/70 mmHg) median from 3 measurements; start of measurement after patients has been seated for at least 5 min)
• Current intake of Aliskiren, Digoxin or ACE-inhibitors at BL (treatment change from ACE-inhibitors to Telmisartan is allowed, with treatment start of Telmisartan at BL)
• Current intake of antidepressants (e.g., Amitriptylin), antiepileptics (e.g., Gabapentin, Pregabalin, Lamotrigine), Duloxetine, Glutamin, Vitamin E
• Current intake of Telmisartan at SCR
• Insufficient hepatic or renal function at SCR:
o Serum creatinine = 1.5 x upper limit of normal (ULN)
o Total bilirubin > 1.5 x ULN
o GOT/GPT = 3 x ULN or >5 in case of documented liver metastasis
• Impairment of GI function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
• History of or current severe psychological illness or condition
• Uncontrolled coronary angina or symptomatic congestive heart failure (NYHA Class III or IV)
• Patients with current malignant disease, other than that being treated in this study. Exceptions to this exclusion criterion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to SCR; completely resected basal cell and squamous cell skin cancers; and completely resected carcinoma in situ of any type
• Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient`s safety and of the study outcome
• History of or evidence of current active Hepatitis B or C or HIV infection with documentation not older than 8 weeks (due to blood sample processing for lipid profile analysis)
• Known hypersensitivity to any component of the IMP
• Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test
• Females of reproductive potential not willing to use highly effective contraception (non-hormonal contraceptive method with a failure rate of < 1% per year, or combination of two effective non-hormonal contraceptive methods, e.g. barrier method and spermicide)
• Alcohol, drug or chemical abuse
• Current participation in another interventional clinical trial or participation within the last 90 days
• Underage or incapable patients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method