Prevention of Paclitaxel-induced Neuropathic Pain in Patients With Planned Paclitaxel Chemotherapy (PrevTel)

Inclusion Criteria:

• Patients with a diagnosis of ovarian or breast cancer who are clinically eligiblefor paclitaxel therapy and for whom paclitaxel chemotherapy is planned (with use ofstandard 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 neurologicallystable, having no new neurological deficits on clinical examination, and no newfindings on CNS imaging as documented in clinical routine care. If patients requiresteroids for management of CNS metastases, they must have been on a stable dose ofsteroids for 2 weeks preceding SCR.

• Written informed consent obtained prior to the initiation of any protocol-requiredprocedures

• 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 withcyclophosphamide and an anthracycline as part of an ongoing adjuvant or neo-adjuvantregimen is allowed)

• Current or planned combinational chemotherapy-regimens, e.g., with platinum-baseddrugs (Her2 antibodies are allowed; paclitaxel combination with trastuzumab +/-pertuzumab is allowed)

• All primary central nervous system (CNS) tumors or symptomatic CNS metastases thatare neurologically unstable (Note: Only patients with controlled CNS metastases mayparticipate in this trial)

• Previously reported intolerance to Angiotensin II (AT1) -receptor-blockers

• Hypotension (blood pressure < 110/70 mmHg; median from 3 measurements; start ofmeasurement after patients has been seated for at least 5 minutes)

• Current intake of aliskiren, digoxin or Angiotensin-converting-enzyme (ACE)-inhibitors at baseline (BL) (treatment change from ACE-inhibitors totelmisartan 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:

• Serum creatinine ≥ 1.5 x upper limit of normal (ULN)

• Total bilirubin > 1.5 x ULN

• Glutamate-Oxalacetete-Transaminase/Glutamate-Pyruvate-Transaminase (GOT/GPT) ≥ 3 x ULN or >5 in case of documented liver metastasis

• Impairment of gastrointestinal (GI) function or GI disease that may significantlyalter 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 (New YorkHeart Association) Class III or IV)

• Patients with current malignant disease, other than that being treated in thisstudy. Exceptions to this exclusion criterion include the following: malignanciesthat were treated curatively and have not recurred within 2 years prior to SCR;completely resected basal cell and squamous cell skin cancers; and completelyresected carcinoma in situ of any type

• Evidence of significant uncontrolled concomitant diseases or serious and/oruncontrolled diseases that are likely to interfere with the evaluation of thepatient's safety and of the study outcome

• History of or evidence of current active Hepatitis B or C or Human ImmunodeficiencyVirus (HIV) infection with documentation not older than 8 weeks (due to blood sampleprocessing for lipid profile analysis)