patients with planned Paclitaxel chemotherapy due to ovarian or breast cancer MedDRA version: 20.0 Level: LLT Classification code 10077974 Term: Peripheral neuropathic pain System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Telmisartan AbZ
Product Name: Telmisartan 40 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: TELMISARTAN
CAS Number: 144701-48-4
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Fraunhofer Gesellschaft for its Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate efficacy of Telmisartan to prevent new onset of PIPNP in patients requiring Paclitaxel chemotherapy due to ovarian or breast cancer until W12, assessed by the DN4 questionnaire;Secondary Objective: Incidence of PIPNP and comparison to available study data and the literature Assessment of pain intensity, pain pattern and pain quality and their change over the 12 weeks by the PainDetect questionnaire and patient global pain visual analogue scale (VAS-Pain) Determination of the cumulative incidence of neuropathic pain over 12 weeks Assessment of quality of life and its change over 12 weeks by the FACT/GOG-NTX questionnaire Quantification of the incidence of Paclitaxel-associated acute pain syndrome (PAPS) Determination of the proportion of patients with need of PIPNP symptomatic therapy Assessment of frequency, severity and relatedness of adverse events explorative: Lipid profile analysis, Assessment of QST profile, Correlation of new onset of PIPNP and pain intensity with lipid profile and QST, Efficacy and safety comparison of different telmisartan doses on incidence and severity of PIPNP symptoms Comparison of PIPNP incidence to available study data and the literature ;Primary end point(s): • Proportion of patients with absence of PIPNP at W12 characterized by DN4 score: DN4 < 4 (DN4 Score 0-10);Timepoint(s) of evaluation of this end point: The DN4 score will be assessed at baseline and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients with new onset of PIPNP at all visits, assessed using the DN4 questionnaire (DN4 = 4) and comparison to available study data and the literature • DN4 and change to BL • PainDetect score and change to BL • VAS-Pain score and change to BL • Incidence of neuropathic pain (as determined by the treating physician) • FACT/GOG-NTX score and change to BL (QoL) • Incidence of Paclitaxel-associated acute pain syndrome (PAPS) • Proportion of patients in need of PIPNP symtomatic therapy (as decided by the treating physician) Explorative variables: • Lipid profile analysis before and after Telmisartan and Paclitaxel start • Assessment of QST profile at selected visits • Correlation of new onset of PIPNP and pain intensity with lipid profile and QST result • Efficacy and safety comparison of different telmisartan doses (adaption to a daily dose of 60 mg/day will be allowed if 80 mg/day is not tolerated) on incidence and severity of PIPNP symptoms Safety: • Frequency, type, severity and relatedness of adverse events (according to CTCAE version 4.0) ;Timepoint(s) of evaluation of this end point: baseline, week 2, week 4, week 7, week 10 and week 12 | — |
Countries
Germany
Contacts
Public ContactDepartment Clinical Research
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Outcome results
None listed