Clinical trial · Interventional
KORTUC: Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour Response
Phase I 'Run in' Study Followed by Randomised Phase II Trial Testing Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Women With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a study aimed at testing a commonly available and inexpensive chemical (hydrogen peroxide) for safety and activity in sensitising large cancerous lumps in the breast to a standard course of radiotherapy in women with poorly controlled symptoms. Laboratory research and initial clinical trials in Japan suggest that 4 to 6 injections of a radiation sensitiser ('KORTUC') based on very dilute (0.5%) hydrogen peroxide injected into cancers under local anaesthetic twice a week during radiotherapy greatly increases the effectiveness of standard doses of radiotherapy alone. The side effects are limited to mild/moderate discomfort at the injection site for up to 24 hours reported by Japanese breast cancer patients in whom this treatment has been tested. Complete tumour shrinkage in 70/71 (98%) primary breast cancers up to 5 cm diameter have been reported by Japanese collaborators.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrogen Peroxide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy + radiation sensitizer
- description
- Patients in phase I and patients randomised to the test group in phase II will receive standard radiotherapy for breast cancer + a radiation sensitizer
- interventionNames
- Drug: Hydrogen Peroxide
- type
- NO_INTERVENTION
- label
- Radiotherapy alone
- description
- Patients randomised to the control group in phase II will receive standard radiotherapy for breast cancer alone.
Primary outcomes (2)
- measure
- Phase I: Patient reported maximum intra-tumoural pain intensity over duration of treatment
- timeFrame
- During radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 years * Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases * Radical/high dose palliative radiotherapy required for lifetime control of local morbidities * Patient physically and mentally fit for radical/high dose palliative radiotherapy * Target tumour accessible for intra-tumoural injection * At least one tumour diameter ≥30 mm measurable by ultrasound or magnetic resonance imaging * Patient available for minimum 3 months follow up post-treatment prior to any surgical resection * Negative pregnancy test within 7 days of starting radiotherapy in women of child bearing potential and an ability/willingness to protect against pregnancy for 3 months post- radiotherapy * Patient offers written informed consent Exclusion Criteria: * Prior radiotherapy to the target area * Anatomical location \&/or extent of disease difficult to access for safe intra-tumoural drug injections, for example by virtue of contiguous major blood vessels and/or brachial plexus
References
Publications (0)
Data not yet available