Neuropathic PainPhase 2PrevTelNCT05322889
Prevention of Paclitaxel-induced Neuropathic Pain in Patients With Planned Paclitaxel Chemotherapy (PrevTel)
A Phase 2 study testing Telmisartan tablets in people with Neuropathic Pain and Chemotherapy Effect, run by Dr. Frank Behrens at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Neuropathic Pain, Chemotherapy Effect
- What is being tested?
- Telmisartan tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 9 Apr 2020to 30 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 21Show fewer
- 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
- Impairment of gastrointestinal (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 (New York Heart Association) 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 Human Immunodeficiency Virus (HIV) infection with documentation not older than 8 weeks (due to blood sample processing for lipid profile analysis)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Haematology/Medical Onkology, University Hospital, Goethe-University Frankfurt
Frankfurt, 60590
About this study
Official title: Prevention of Paclitaxel-induced Neuropathic Pain by Telmisartan in Patients With Planned Paclitaxel Chemotherapy Due to Ovarian or Breast Cancer (PrevTel)
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
Read the detailed description
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.
- Conditions
- Neuropathic Pain, Chemotherapy Effect
- Being tested
- Telmisartan tablets
- Keywords
- chemotherapy induced peripheral neuropathic pain, breast cancer; ovarian cancer; paclitaxel
- Medical subject headings
- Neuralgia, Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan tabletsDrug
12 weeks treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention with Telmisartan | Experimental | Telmisartan (open), 80 mg daily p.o. (after run-in phase with 40 mg for 7 days).
for 12 weeks Receives: Drug: Telmisartan tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 12
Secondary outcomes (37)
Proportion of patients with new onset of PIPNP
Douleur Neuropathique 4 (DN4) questionnaire (DN4 ≥ 4) higher score means more pain, minimum 0 to maximum 10 points
Measured: Day 14
Proportion of patients with new onset of PIPNP
DN4 questionnaire (DN4 ≥ 4) higher score means more pain, minimum 0 to maximum 10 points
Measured: Day 28
Proportion of patients with new onset of PIPNP
DN4 questionnaire (DN4 ≥ 4) higher score means more pain, minimum 0 to maximum 10 points
Measured: Day 49
Proportion of patients with new onset of PIPNP
DN4 questionnaire DN4 ≥ 4
Measured: Day 70
Proportion of patients with new onset of PIPNP
DN4 questionnaire DN4 ≥ 4 higher score means more pain, minimum 0 to maximum 10 points
Measured: Day 84
Change of pain intensity to baseline - Paindetect
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 14
Change of pain intensity to baseline - Paindetect
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 28
Change of pain intensity to baseline - Paindetect
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 49
Change of pain intensity to baseline - Paindetect
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 70
Change of pain intensity to baseline - Paindetect
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 84
Change of pain intensity to baseline - VAS
patient global pain visual analogue scale (VAS-Pain), minimum 0 to 10, higher score means more pain
Measured: Day 14
Change of pain intensity to baseline - VAS
patient global pain visual analogue scale (VAS-Pain), minimum 0 to 10, higher score means more pain
Measured: Day 28
Change of pain intensity to baseline - VAS
patient global pain visual analogue scale (VAS-Pain), minimum 0 to 10, higher score means more pain
Measured: Day 49
Change of pain intensity to baseline - VAS
patient global pain visual analogue scale (VAS-Pain), minimum 0 to 10, higher score means more pain
Measured: Day 70
Change of pain intensity to baseline - VAS
patient global pain visual analogue scale (VAS-Pain), minimum 0 to 10, higher score means more pain
Measured: Day 84
Change in pain pattern to baseline
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 14
Change in pain pattern to baseline
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 28
Change in pain pattern to baseline
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 49
Change in pain pattern to baseline
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 70
Change in pain pattern to baseline
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 84
Change of pain quality to baseline
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 14
Change of pain quality to baseline
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 28
Change of pain quality to baseline
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 49
Change of pain quality to baseline
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 70
Change of pain quality to baseline
PainDetect questionnaire, higher score means more pain, minimum 0 to 38 maximum
Measured: Day 84
Change in quality of life (QoL) to baseline
Functional Assessment of Cancer Therapy/Gynecologic Oncology (FACT/ GOG-NTX), 38 items questionaire each to be scored from 0 (Not at all) to 4 (Very much) - total score could be between 0 and 152 Group-Neurotoxicity (FACT/GOG-NTX questionnaire) - some items are reverse scored. Subscale scores, total scores possible
Measured: Day 14
Change in quality of life (QoL) to baseline
Functional Assessment of Cancer Therapy/Gynecologic Oncology (FACT/ GOG-NTX), 38 items questionaire each to be scored from 0 (Not at all) to 4 (Very much) - total score could be between 0 and 152 Group-Neurotoxicity (FACT/GOG-NTX questionnaire) - some items are reverse scored. Subscale scores, total scores possible
Measured: Day 49
Change in quality of life (QoL) to baseline
Functional Assessment of Cancer Therapy/Gynecologic Oncology (FACT/ GOG-NTX), 38 items questionaire each to be scored from 0 (Not at all) to 4 (Very much) - total score could be between 0 and 152
Measured: Day 28
Change in quality of life (QoL) to baseline
Functional Assessment of Cancer Therapy/Gynecologic Oncology (FACT/ GOG-NTX), 38 items questionaire each to be scored from 0 (Not at all) to 4 (Very much) - total score could be between 0 and 152
Measured: Day 70
Change in quality of life (QoL) to baseline
Functional Assessment of Cancer Therapy/Gynecologic Oncology (FACT/ GOG-NTX), 38 items questionaire each to be scored from 0 (Not at all) to 4 (Very much) - total score could be between 0 and 152
Measured: Day 84
cumulative incidence of neuropathic pain
documented by physician
Measured: throughout study treatment - 12 weeks
Quantification of the incidence of paclitaxel-associated acute pain syndrome (PAPS)
documented by physician
Measured: throughout study treatment - 12 weeks
proportion of patients in need of PIPNP symptomatic therapy
determined by treating physician - documented in case report form
Measured: throughout study treatment - 12 weeks
Assessment of frequency of adverse events
determined by using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: throughout study treatment - 12 weeks
Assessment of severity of adverse events
determined by using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: throughout study treatment - 12 weeks
Assessment relatedness of adverse events
determined by using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: throughout study treatment - 12 weeks
Assessment of type of adverse events
determined by using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: throughout study treatment - 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start9 Apr 2020
- Primary completion4 Oct 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- monocentric, open label, single-arm trial
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Frank Behrens
- Sponsor type
- University, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital
- Responsible party
- Sponsor-investigator, Dr. Frank Behrens, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
- Investigators
- Martin Sebastian, MD, Principal investigator, Department of Haematology/Medical Onkology, University Hospital, Goethe-University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322889
- Sponsor's protocol ID
- TMP-0315-2018
- Acronym
- PrevTel
- Status last verified
- Aug 2024
- First submitted
- 4 Apr 2022
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Paclitaxel-induced Neuropathic Pain by Telmisartan in Patients With Planned Paclitaxel Chemotherapy Due to Ovarian or Breast Cancer (PrevTel)
- ClinicalTrials.gov ID
- NCT05322889
- Acronym / sponsor ID
- PrevTel / TMP-0315-2018
- Conditions
- Neuropathic Pain, Chemotherapy Effect
- Keywords
- chemotherapy induced peripheral neuropathic pain, breast cancer; ovarian cancer; paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Dr. Frank BehrensUniversity, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- monocentric, open label, single-arm trial
| Arm | Type | Receives |
|---|---|---|
| Intervention with Telmisartan | Experimental | Drug: Telmisartan tabletsTelmisartan (open), 80 mg daily p.o. (after run-in phase with 40 mg for 7 days). for 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telmisartan tablets12 weeks treatment | Drug | Intervention with Telmisartan |
Primary outcome
efficacy of telmisartan to prevent new onset of Paclitaxel- induced peripheral neuropathic pain (PIPNP)
Time frame: week 12
Proportion of patients without onset of PIPNP measured by median Quality of life questionaire (doleur neuropathic questionnaire) DN4, DN4 < 4
37 secondary outcomes
Proportion of patients with new onset of PIPNP
Time frame: Day 14
Proportion of patients with new onset of PIPNP
Time frame: Day 28
Proportion of patients with new onset of PIPNP
Time frame: Day 49
Proportion of patients with new onset of PIPNP
Time frame: Day 70
Proportion of patients with new onset of PIPNP
Time frame: Day 84
Change of pain intensity to baseline - Paindetect
Time frame: Day 14
Change of pain intensity to baseline - Paindetect
Time frame: Day 28
Change of pain intensity to baseline - Paindetect
Time frame: Day 49
Change of pain intensity to baseline - Paindetect
Time frame: Day 70
Change of pain intensity to baseline - Paindetect
Time frame: Day 84
Change of pain intensity to baseline - VAS
Time frame: Day 14
Change of pain intensity to baseline - VAS
Time frame: Day 28
Change of pain intensity to baseline - VAS
Time frame: Day 49
Change of pain intensity to baseline - VAS
Time frame: Day 70
Change of pain intensity to baseline - VAS
Time frame: Day 84
Change in pain pattern to baseline
Time frame: Day 14
Change in pain pattern to baseline
Time frame: Day 28
Change in pain pattern to baseline
Time frame: Day 49
Change in pain pattern to baseline
Time frame: Day 70
Change in pain pattern to baseline
Time frame: Day 84
Change of pain quality to baseline
Time frame: Day 14
Change of pain quality to baseline
Time frame: Day 28
Change of pain quality to baseline
Time frame: Day 49
Change of pain quality to baseline
Time frame: Day 70
Change of pain quality to baseline
Time frame: Day 84
Change in quality of life (QoL) to baseline
Time frame: Day 14
Change in quality of life (QoL) to baseline
Time frame: Day 49
Change in quality of life (QoL) to baseline
Time frame: Day 28
Change in quality of life (QoL) to baseline
Time frame: Day 70
Change in quality of life (QoL) to baseline
Time frame: Day 84
cumulative incidence of neuropathic pain
Time frame: throughout study treatment - 12 weeks
Quantification of the incidence of paclitaxel-associated acute pain syndrome (PAPS)
Time frame: throughout study treatment - 12 weeks
proportion of patients in need of PIPNP symptomatic therapy
Time frame: throughout study treatment - 12 weeks
Assessment of frequency of adverse events
Time frame: throughout study treatment - 12 weeks
Assessment of severity of adverse events
Time frame: throughout study treatment - 12 weeks
Assessment relatedness of adverse events
Time frame: throughout study treatment - 12 weeks
Assessment of type of adverse events
Time frame: throughout study treatment - 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Sebastian, MD principal investigator
Department of Haematology/Medical Onkology, University Hospital, Goethe-University Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telmisartan tablets in people with Neuropathic Pain and Chemotherapy Effect, run by Dr. Frank Behrens at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of telmisartan to prevent new onset of Paclitaxel- induced peripheral neuropathic pain (PIPNP) (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.