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Telmisartan (open), 80 mg daily p.o. (after run-in phase with 40 mg for 7 days).

for 12 weeks

Telmisartan tablets

Christin Jonetzko

Tanja Rossmanith, PhD

Martin Sebastian, MD

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

Paclitaxel is a cytostatic drug that is widely used for the first-line treatment of breast- and ovarian cancer and causes neuropathic pain in up to 87% of treated patients Treating mice with telmisartan causes a strong reduction of PIPNP, thus indicating that telmisartan may be a promising pharmacological treatment option for PIPNP in patients. It is proposed that telmisartan reduces the inflammatory component of PIPNP.

Telmisartan has a good risk profile, low occurrence of side effects and is generally well tolerated in patients.These collective characteristics make it a suitable, already approved and appropriate substance for combination therapy with paclitaxel.

Therefore, telmisartan is a promising candidate to potentially prevent PIPNP in patients whose safety profile is well known due to preclinical and clinical trials for the indication of hypertension and coronary heart disease. Moreover, due to its mechanisms it might as well reduce symptoms of PIPNP sufficiently without severe side effects.

To validate these observations clinically, this phase IIa clinical trial will be conducted with breast and ovarian cancer patients requiring in-label paclitaxel-chemotherapy. The efficacy of a 12-week telmisartan treatment initiated before the first administration of paclitaxel to prevent PIPNP will be assessed.

Moreover, beside lipid profiles, quantitative sensoric testing of pain characteristics in focus on biomarker detection and development that may be useful for a precision medicine approach will be assessed.

monocentric, open label, single-arm trial

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

Prevention of Paclitaxel-induced Neuropathic Pain by Telmisartan in Patients With Planned Paclitaxel Chemotherapy Due to Ovarian or Breast Cancer (PrevTel)

Proportion of patients without onset of PIPNP measured by median Quality of life questionaire (doleur neuropathic questionnaire) DN4, DN4 \< 4

Douleur Neuropathique 4 (DN4) questionnaire (DN4 ≥ 4) higher score means more pain, minimum 0 to maximum 10 points

DN4 questionnaire (DN4 ≥ 4) higher score means more pain, minimum 0 to maximum 10 points

DN4 questionnaire DN4 ≥ 4 higher score means more pain, minimum 0 to maximum 10 points

PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum

patient global pain visual analogue scale (VAS-Pain), minimum 0 to 10, higher score means more pain

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX questionnaire) - some items are reverse scored. Subscale scores, total scores possible

determined by treating physician - documented in case report form

determined by using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prevention of Paclitaxel-induced Neuropathic Pain in Patients With Planned Paclitaxel Chemotherapy (PrevTel)	NCT05322889	Neuropathic Pai... Chemotherapy Ef...	Telmisartan tab...	18 Years - 80 Years	Fraunhofer Institute for Molecular Biology and Applied Ecology
Prevention of Paclitaxel-induced Neuropathic Pain in Patients With Planned Paclitaxel Chemotherapy (PrevTel)	NCT05322889	Neuropathic Pai... Chemotherapy Ef...	Telmisartan tab...	18 Years - 80 Years	Fraunhofer Institute for Molecular Biology and Applied Ecology

Spots Global Cancer Trial Database for chemotherapy induced peripheral neuropathic pain, breast cancer; ovarian cancer; paclitaxel