MedTrace Logo

KORTUC: Intra-tumoural Hydrogen Peroxide as a Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer in Terms of Toxicity and Tumour Response

NCT02757651 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-11-27

No results posted yet for this study

Summary

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

Interventions

DRUG

Hydrogen Peroxide

Hydrogen Peroxide

Sponsors & Collaborators

  • Kortuc, Inc.

    collaborator INDUSTRY

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Navita Somaiah · The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-19
Primary Completion
2020-11-12
Completion
2020-11-12

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02757651 on ClinicalTrials.gov