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

NCT05322889 | Completed Phase 2 DMC

• 1 other identifier: TMP-0315-2018
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Neuropathic Pain; Chemotherapy Effect

Keywords

chemotherapy induced peripheral neuropathic pain, breast cancer; ovarian cancer; paclitaxel

Outcome Measures

Primary Outcomes (1)

• efficacy of telmisartan to prevent new onset of Paclitaxel- induced peripheral neuropathic pain (PIPNP)

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

  week 12

Secondary Outcomes (37)

• Proportion of patients with new onset of PIPNP

  Day 14

• Proportion of patients with new onset of PIPNP

  Day 28

• Proportion of patients with new onset of PIPNP

  Day 49

• Proportion of patients with new onset of PIPNP

  Day 70

• Proportion of patients with new onset of PIPNP

  Day 84

Study Arms (1)

Intervention with Telmisartan

EXPERIMENTAL

Telmisartan (open), 80 mg daily p.o. (after run-in phase with 40 mg for 7 days). for 12 weeks

Drug: Telmisartan tablets

Interventions

Telmisartan tablets DRUG

12 weeks treatment

Intervention with Telmisartan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 Angiotensin II (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 minutes)
• Current intake of aliskiren, digoxin or Angiotensin-converting-enzyme (ACE)-inhibitors at baseline (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:
• 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

Sponsors & Collaborators

• Dr. Frank Behrens: lead
• Johann Wolfgang Goethe University Hospital: collaborator

Study Sites (1)

Department of Haematology/Medical Onkology, University Hospital, Goethe-University Frankfurt

Frankfurt, 60590, Germany

Location

MeSH Terms

Conditions

Neuralgia; Breast Neoplasms; Ovarian Neoplasms

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Martin Sebastian, MD

  Department of Haematology/Medical Onkology, University Hospital, Goethe-University Frankfurt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: no blinding necessary
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinical research - Representative of the Sponsor

Model Details: monocentric, open label, single-arm trial

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 12, 2022
• Study Start: April 9, 2020
• Primary Completion: October 4, 2022
• Study Completion: June 30, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

DE (1)