Recruiting
Phase 2

Hydrogen Peroxide

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT04929535

Conditions

Basal Cell Carcinoma

Squamous Cell Carcinoma of Skin Differentiated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hydrogen Peroxide 30 % Topical Solution

Study Details

Brief summary:

Previous work suggests that topical treatment with 33% hydrogen peroxide can reduce lesion size and, in about half of patients, can cause complete pathologic response. For patients with reduction in lesions size, the required size of the surgical excision or radiation field will be similarly decreased, thus potentially limiting associated morbidity and better cosmetic outcomes. Additionally, patients that experience a complete pathological response will be able to avoid additional treatment with either surgery or radiation. This will benefit both patients as well as helping to decreased use of health care resources. For the current study we will be using 30% hydrogen peroxide as it is commercially available. If this study shows positive results, it could lead to significant benefit on both a patient and systems level. Locally, our cancer Centre treats approximately 700 new patients per year who fit into the study criteria and could potentially benefit from this novel neoadjuvant treatment that is fairly inexpensive.

Conditions

Basal Cell Carcinoma

Squamous Cell Carcinoma of Skin Differentiated

Study ID

NCT04929535

Start date

Sep, 2022

Status verified date

Aug, 2021

Completion date

Dec, 2023

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pathologically confirmed measurable basal cell carcinoma (BCC) or well to moderately differentiated squamous cell carcinoma (SCC)
  • Age 18 years or older
  • Able to provide informed consent

Exclusion Criteria:

  • Lesion with indistinct borders
  • Any evidence of metastatic disease
  • Poor performance status (Eastern Cooperative Oncology Group > 1) with life expectancy of less than 2 years
  • Gorlins syndrome, a genetic predisposition to multiple skin cancers where surveillance and early intervention is of paramount importance
  • Any recurrent cancer after surgery or radiation
  • Very extensive carcinoma that cannot be readily removed by surgery or treated by radiation using orthovoltage or electron beam
  • History of cutaneous photosensitization, porphyria or photodimerization as their tolerance to hydrogen peroxide application is unpredictable
  • Previous application of 5-Fluorouracil cream to the lesion within the last 8 weeks
  • Any immune-compromised patients where skin cancers can be very aggressive
  • Patients who are unwilling to return for 1-year follow-up assessment
  • Poorly differentiated SCC

Study Design

Enrollment

51 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 30% hydrogen peroxide

30% hydrogen peroxide liquid topical application. 2 drops (0.10 ml) of hydrogen peroxide solution per centimeter of lesion. Once every week for continuous 4 weeks. If there is complete clinical response, further hydrogen peroxide will not be done.

placebo comparator: 3% hydrogen peroxide

3% hydrogen peroxide liquid topical application. 2 drops (0.10 ml) of hydrogen peroxide solution per centimeter of lesion. Once every week for continuous 4 weeks. If there is complete clinical response, further hydrogen peroxide will not be done.

Interventions

Hydrogen Peroxide 30 % Topical Solution

Patients will be seen by the radiation therapists involved with the study after randomization. Prior to application of hydrogen peroxide solutions, the patients' lesions will be prepared and debrided of keratinous debris and oils using sterile 70% isopropyl alcohol. Then, the appropriate hydrogen peroxide solution (30% for Arm 1 or 3% for Arm 2) will be rubbed into the lesion and a 1cm border all around the lesion until blanching of the lesion is observed. Hydrogen peroxide will be reapplied after one hour. This process will be repeated weekly for three additional applications for this study. If there is complete clinical response, further hydrogen peroxide will not be done. Patients will be accessed for definitive treatment 4 weeks later.

Primary outcome measure

  • Change in lesion size [ Time Frame: 4 weeks after the last application of hydrogen peroxide ]

Central Contacts and Locations

Central contacts

Robin Sachdeva, PhD

5196858500robin.sachdeva@lhsc.on.ca

Locations

London Regional Cancer Program

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Robin Sachdeva, PhD

519-685-8500robin.sachdeva@lhsc.on.ca

Principal Investigator:

Jinka Sathya, MD

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Aug 30, 2022

Last verified

Aug, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2022-08-30.