Phase 3 Peripheral Neuropathy Trial, Recruiting NCT04299893 Sponsor: Bernardino Clavo, MD, PhD Condition: Peripheral Neuropathy
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Phase 3 Peripheral Neuropathy Trial, Recruiting

NCT04299893
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People who have any type of cancer at any stage, are being treated with any type of chemotherapy, and are expected to live at least 6 months or more
  • People who have been diagnosed with painful nerve damage caused by chemotherapy, rated at a moderate-to-severe level (Grade 2 or higher), lasting at least 3 months, and who have not started any new pain or nerve treatments in the past month
  • People whose average pain score is 3 or higher out of 10 (measured using a standard pain questionnaire), lasting at least 3 months after completing chemotherapy
  • Women who could become pregnant must have a negative pregnancy test (blood or urine) before joining, and must agree to use appropriate contraception starting at least 14 days before the first treatment session through to 14 days after the last session
  • People who have read, signed, and dated the trial's informed consent form

Who may not be able to join:

  • People under 18 years of age
  • Women who are pregnant at the time of joining
  • Women who could become pregnant but are unwilling to take a pregnancy test or use appropriate contraception during the required period around treatment sessions
  • People where there is reason to believe their nerve pain may have been present before chemotherapy due to another cause, such as nerve compression or diabetes, in the same area of the body
  • People with a psychiatric illness or personal circumstances that may make it difficult to follow the trial's requirements
  • People who are unable to complete the questionnaires used to measure quality of life in the trial
  • People with certain liver function test results that are more than 5 times above the normal range (confirm with trial site)
  • People with kidney function test results (creatinine) more than 3 times above the normal range
  • People who are medically unstable or have a severe illness that is not under control
  • People whose cancer is not currently under control
  • People whose cancer has spread to the membranes surrounding the brain and spinal cord
  • People with a life expectancy of less than 6 months
  • People who have a medical reason preventing them from receiving the treatment through rectal administration, or who are unable to attend the scheduled treatment sessions
  • People with a known allergy to ozone
  • People who do not meet all of the inclusion criteria listed above

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Bernardino Clavo, MD, PhD, Dr. Negrín University Hospital, Las Palmas, Spain

Phone: (34)928449278

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Bernardino Clavo, MD, PhD
Registry
ClinicalTrials.gov
Start date
30 November 2020
Est. completion
30 September 2027

Where this trial is recruiting

🇪🇸 Spain

Primary endpoints

Change from Baseline in "Average pain" according to the Brief Pain Inventory-Short Form (BPI-SF) (at the end of ozone therapy); Direct Hospital Cost (at the end of ozone therapy)

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: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov