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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT05322889

NCT05322889
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with ovarian or breast cancer, and your doctor has planned for you to receive a chemotherapy drug called paclitaxel as part of your standard care
  • You are a woman aged 18 to 80 years old
  • If you have had cancer spread to your brain, you must have finished radiation therapy or surgery for it more than 2 weeks before the screening visit, be neurologically stable with no new symptoms or changes on brain scans, and if you take steroids for this, you must have been on a steady dose for at least 2 weeks before screening
  • You are willing and able to follow the study procedures and requirements
  • You have given written consent to take part before any study procedures begin

Who may not be able to join:

  • You have been previously diagnosed with, or currently have, nerve pain in your hands or feet (peripheral neuropathic pain)
  • You have other severe pain that could make it difficult to assess nerve pain
  • You scored 4 or higher on a nerve pain questionnaire called the DN4 (confirm with trial site)
  • You have received chemotherapy (including paclitaxel) within the last 5 years — although treatment with cyclophosphamide and an anthracycline as part of an ongoing adjuvant or neo-adjuvant regimen is allowed
  • You are currently receiving, or planning to receive, paclitaxel in combination with other chemotherapy drugs, such as platinum-based drugs — though paclitaxel combined with certain targeted therapies (trastuzumab with or without pertuzumab) is allowed
  • You have a primary brain tumour, or cancer that has spread to your brain and is causing unstable neurological symptoms
  • You have had a previous bad reaction or intolerance to a type of blood pressure medication called angiotensin II receptor blockers (AT1-receptor blockers)
  • Your blood pressure is too low (below 110/70 mmHg based on an average of 3 measurements taken after sitting for at least 5 minutes)
  • You are currently taking any of the following medications: aliskiren, digoxin, or ACE-inhibitor blood pressure medications — though switching from an ACE-inhibitor to telmisartan at the start of the trial may be allowed (confirm with trial site)
  • You are currently taking certain antidepressants (such as amitriptyline), anti-epileptic medicines (such as gabapentin, pregabalin, or lamotrigine), duloxetine, glutamine, or vitamin E
  • You are currently taking a blood pressure medication called telmisartan at the time of your screening visit
  • Your liver or kidney function is not within acceptable levels based on blood tests at your screening visit (confirm specific values with trial site)
  • You have a stomach or bowel condition that could affect how your body absorbs medication, such as ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, a malabsorption condition, or previous removal of part of your small bowel
  • You have a history of or currently have a severe psychiatric or psychological illness
  • You have uncontrolled chest pain (angina) or significant heart failure with moderate to severe symptoms
  • You currently have another active cancer, other than the one being treated in this study — though some exceptions may apply, such as a cancer that was fully treated and has not returned in the past 2 years, or certain fully removed skin cancers or non-invasive cancers (confirm with trial site)
  • You have other significant uncontrolled or serious health conditions that could affect your safety or the results of the study
  • You have a current or past active Hepatitis B, Hepatitis C, or HIV infection, confirmed by test results no older than 8 weeks

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Dr. Frank Behrens
Registry
clinicaltrials_gov
Start date
9 April 2020
Est. completion
4 October 2022

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov