Phase 3 Peripheral Neuropathy Trial, Recruiting NCT06706544 Sponsor: Bernardino Clavo, MD, PhD Condition: Peripheral Neuropathy
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Phase 3 Peripheral Neuropathy Trial, Recruiting

NCT06706544
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 previously received chemotherapy for any type of cancer
  • People who have been diagnosed with numbness or tingling caused by chemotherapy-related nerve damage, where the symptoms are classified as moderate to severe (Grade 2 or higher) and have lasted for 3 months or more
  • People who stopped receiving nerve-damaging chemotherapy at least 3 months ago
  • People whose cancer is currently stable or in remission
  • People with a life expectancy of at least 6 months
  • Women who could become pregnant must have a negative pregnancy test before joining and must use appropriate contraception starting at least 14 days before the first treatment session until at least 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, breastfeeding, suspected of being pregnant, or who are of childbearing age and are not using adequate contraception
  • People whose numbness or tingling is thought to be caused by diabetes-related nerve damage or nerve compression, rather than chemotherapy
  • People with severe psychiatric conditions
  • People who are unable to complete quality-of-life questionnaires
  • People with significantly elevated kidney function markers in their blood (more than 5 times the upper limit of normal for creatinine) (confirm with trial site)
  • People who are medically unstable or who need urgent medical interventions in the near term
  • People whose cancer is currently progressing and who need to start or continue nerve-damaging chemotherapy
  • People with a life expectancy of less than 6 months for any reason
  • People with a known allergy to ozone, a condition called G6PD deficiency, or a condition called hemochromatosis
  • People who have medical reasons that prevent rectal ozone treatment, or who are unable to attend treatment sessions regularly
  • 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 27 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, Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain

Phone: 34928449278

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Bernardino Clavo, MD, PhD
Registry
ClinicalTrials.gov
Start date
7 February 2025
Est. completion
31 December 2029

Where this trial is recruiting

🇪🇸 Spain

Primary endpoints

Change from baseline in "numbness and tingling" self-perceived by patients at the end of follow-up (week 28 after the commencement of ozone treatment); Change from Baseline in quality of life by the EQ-...

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: 27 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