Basal Cell CarcinomaPhase 2NCT04929535
Hydrogen Peroxide Trial to Investigate the Efficacy of 30%H2O2 as a Topical Application Before Definitive Treatment
A Phase 2 study testing Hydrogen Peroxide 30 % Topical Solution in people with Basal Cell Carcinoma and Squamous Cell Carcinoma of Skin Differentiated, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Squamous Cell Carcinoma of Skin Differentiated
- What is being tested?
- Hydrogen Peroxide 30 % Topical Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2022to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Regional Cancer Program
London, Ontario, N6A 5W9
Robin Sachdeva, PhD, 519-685-8500 ext. 54005, robin.sachdeva@lhsc.on.ca
Jinka Sathya, MD
About this study
Official title: A Phase 2 Double-blind Placebo Randomized Controlled Trial of 30% Topical Application of Hydrogen Peroxide as Neoadjuvant Treatment of Non-melanoma Skin Cancers Prior to Definitive Surgery or Radiation
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.
Read the detailed description
Non-melanoma skin cancers (NMSC) are the most commonly occurring cancers worldwide and the incidence of these malignancies is steadily rising secondary to the advancing age of the general population as well as sun exposure. Gold standard treatment modalities for NMSC include surgical excision and radiation therapy. Both of these treatments are accompanied by risks to the patient including pain, bleeding, infection, scarring and pigment alterations. Larger lesions necessitate treatment of larger areas of skin, which can worsen treatment related toxicities. Patients with NMSC of the head and neck may be particularly concerned regarding these risks as this region is cosmetically sensitive.
For surgery, a recommended margin of 0.5-1.0cm of normal tissue is removed beyond the lesion boarder to decrease risk of recurrence. In an area like the face, reconstruction of excision defects and ultimately aesthetic outcomes are of utmost importance. Particularly large skin can sometimes necessitate rotational flaps or even skin grafting, both of which have drawbacks in terms of healing, scarring, and surgical complications. A similar issue of margins arises with radiation. For patients undergoing radiation treatment with an orthovoltage a margin of 1.0cm is added beyond the clinical boarders of the lesion, while for patients being treated on an electron unit, a 1.5cm margin is added.
Currently, there are no routinely used neoadjuvant treatment option that can be used to help decrease lesion size and therefore limit toxicities associated with definitive treatment (surgery or radiation). However, these has be recent work looking at neoadjuvant use of concentrated hydrogen peroxide in reduction of lesion size (5).
Hydrogen peroxide a product of respiration in mitochondria and an important oxidizing agent in biological system. As it is a potent oxidizing agent, hydrogen peroxide can exert a role in oxidative stress, although the exact mechanism through which this occurs is not yet known. Giulivi and Davies (1) propose that hydrogen peroxide may interact with hemoglobin in the dermal capillaries producing oxidized forms of hemoglobin such as ferryl hemoglobin which is highly reactive. It is therefore possible that hydrogen peroxide could cause necrogenous oxidation and oxygen induced apoptosis of cells in NMSC.
Dilute hydrogen peroxide it is used frequently as a topical antiseptic and hemostatic agent (2). These effects are generally achieved with topical application of 3% hydrogen peroxide to the skin, with little to no side effects for patients aside from some mild discomfort. As far as potential clinical application of more concentrated hydrogen peroxide, a previous investigation examining the use of hydrogen peroxide at or above a concentration of 23% in the treatment of seborrheic keratosis found that the mean number of benign lesions remaining 90 days after treatment was significantly lower in the hydrogen peroxide group compared to placebo (3). The average number of applications of hydrogen peroxide was 6, separated by approximately one-week intervals (3). In this study, the only side effect from application of the hydrogen peroxide solution was less than ten minutes of "burning" at the application site (3). Hydrogen peroxide has also been used in combination with other topical treatments such as non-steroidal anti-inflammatories (NSAIDs) to successfully combat precancerous lesions such as actinic keratosis (4) as well as part of photodynamic therapy protocols in the treatment of skin cancers.
Recently Mundi et al. (5) published a case series looking at the role of a topical application of 33% hydrogen peroxide as neoadjuvant therapy before surgical excision. This series included 11 patients and a total of 17 lesions. Patients received multiple topical applications of hydrogen peroxide and were evaluated 4 weeks after the initial treatment to assess response. There was complete pathological response in 53% of patients and the remained had a statistically significant reduction in the size of the lesion requiring a smaller surgical excision. Although promising, this was a small, non-randomized, non-controlled proof of concept study. Further work is required before this type of treatment could be adopted commonly or used of trial.
However, given its relatively benign nature and previous efficacy in treating other skin growths, hydrogen peroxide may represent a simple yet effective method at shrinking NMSC of the head and neck before they are excised or radiated. In doing so, it could minimize the invasiveness of surgical excision thereby accelerating healing and improving aesthetic outcomes for patients. If patients are being treated with radiation, we may be able to use smaller radiation fields with less side effects, better cosmesis and improved local control.
This double-blind placebo randomized controlled trial will seek to investigate the role of neoadjuvant hydrogen peroxide prior to definitive treatment with either surgery or radiation. For the purposes of this trial a concentration of 30% hydrogen peroxide will be used as this is the highest concentration easily available.
- Being tested
- Hydrogen Peroxide 30 % Topical Solution
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen Peroxide 30 % Topical SolutionDrug
Also called hydrogen peroxide
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.
| Study group | Role | What they receive |
|---|---|---|
| 30% hydrogen peroxide | Experimental | 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. Receives: Drug: Hydrogen Peroxide 30 % Topical Solution |
| 3% hydrogen peroxide | Placebo comparator | 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. Receives: Drug: Hydrogen Peroxide 30 % Topical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lesion size
Reduction in lesion size, measured in square centimeter, 4 weeks after the last application of hydrogen peroxide.
Measured: 4 weeks after the last application of hydrogen peroxide
Secondary outcomes (6)
Proportion of Patients with complete response
Proportion of patients with complete response not requiring surgery or radiation.
Measured: At study completion, an approximate of 1 year
Proportion of patients requiring definitive surgery
Proportion of patients requiring definitive surgery or radiation who achieve complete clinical response, but not complete pathological response following hydrogen peroxide treatment.
Measured: At study completion, an approximate of 1 year
Size of surgically removed skin
Reduction in the size of the skin, measured in square centimeter, that needs to be surgically removed before and after hydrogen peroxide treatment for patients selecting surgery
Measured: At study completion, an approximate of 1 year
Change in the size of the radiation field
Reduction in the size of the radiation field, measured in square centimeter, before and after hydrogen peroxide treatment for patients selecting radiation.
Measured: At study completion, an approximate of 1 year
Local Control
Clinical local control at one year after randomization.
Measured: At study completion, an approximate of 1 year
Adverse Events
Adverse events associated with hydrogen peroxide treatment, assessed using standardized questionnaire one week after each application. Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, Grade 5: Death.
Measured: At baseline, week 1, week 2, week 3, and also at 4 weeks after last hydrogen peroxide application. Adverse events will also be assessed at 3, 6, 9 and 12 months after the baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study startSep 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinka Sathya, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929535
- Sponsor's protocol ID
- JS10934
- Status last verified
- Aug 2021
- First submitted
- 1 Jun 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Double-blind Placebo Randomized Controlled Trial of 30% Topical Application of Hydrogen Peroxide as Neoadjuvant Treatment of Non-melanoma Skin Cancers Prior to Definitive Surgery or Radiation
- ClinicalTrials.gov ID
- NCT04929535
- Acronym / sponsor ID
- JS10934
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-melanoma skin cancers (NMSC) are the most commonly occurring cancers worldwide and the incidence of these malignancies is steadily rising secondary to the advancing age of the general population as well as sun exposure. Gold standard treatment modalities for NMSC include surgical excision and radiation therapy. Both of these treatments are accompanied by risks to the patient including pain, bleeding, infection, scarring and pigment alterations. Larger lesions necessitate treatment of larger areas of skin, which can worsen treatment related toxicities. Patients with NMSC of the head and neck may be particularly concerned regarding these risks as this region is cosmetically sensitive.
For surgery, a recommended margin of 0.5-1.0cm of normal tissue is removed beyond the lesion boarder to decrease risk of recurrence. In an area like the face, reconstruction of excision defects and ultimately aesthetic outcomes are of utmost importance. Particularly large skin can sometimes necessitate rotational flaps or even skin grafting, both of which have drawbacks in terms of healing, scarring, and surgical complications. A similar issue of margins arises with radiation. For patients undergoing radiation treatment with an orthovoltage a margin of 1.0cm is added beyond the clinical boarders of the lesion, while for patients being treated on an electron unit, a 1.5cm margin is added.
Currently, there are no routinely used neoadjuvant treatment option that can be used to help decrease lesion size and therefore limit toxicities associated with definitive treatment (surgery or radiation). However, these has be recent work looking at neoadjuvant use of concentrated hydrogen peroxide in reduction of lesion size (5).
Hydrogen peroxide a product of respiration in mitochondria and an important oxidizing agent in biological system. As it is a potent oxidizing agent, hydrogen peroxide can exert a role in oxidative stress, although the exact mechanism through which this occurs is not yet known. Giulivi and Davies (1) propose that hydrogen peroxide may interact with hemoglobin in the dermal capillaries producing oxidized forms of hemoglobin such as ferryl hemoglobin which is highly reactive. It is therefore possible that hydrogen peroxide could cause necrogenous oxidation and oxygen induced apoptosis of cells in NMSC.
Dilute hydrogen peroxide it is used frequently as a topical antiseptic and hemostatic agent (2). These effects are generally achieved with topical application of 3% hydrogen peroxide to the skin, with little to no side effects for patients aside from some mild discomfort. As far as potential clinical application of more concentrated hydrogen peroxide, a previous investigation examining the use of hydrogen peroxide at or above a concentration of 23% in the treatment of seborrheic keratosis found that the mean number of benign lesions remaining 90 days after treatment was significantly lower in the hydrogen peroxide group compared to placebo (3). The average number of applications of hydrogen peroxide was 6, separated by approximately one-week intervals (3). In this study, the only side effect from application of the hydrogen peroxide solution was less than ten minutes of "burning" at the application site (3). Hydrogen peroxide has also been used in combination with other topical treatments such as non-steroidal anti-inflammatories (NSAIDs) to successfully combat precancerous lesions such as actinic keratosis (4) as well as part of photodynamic therapy protocols in the treatment of skin cancers.
Recently Mundi et al. (5) published a case series looking at the role of a topical application of 33% hydrogen peroxide as neoadjuvant therapy before surgical excision. This series included 11 patients and a total of 17 lesions. Patients received multiple topical applications of hydrogen peroxide and were evaluated 4 weeks after the initial treatment to assess response. There was complete pathological response in 53% of patients and the remained had a statistically significant reduction in the size of the lesion requiring a smaller surgical excision. Although promising, this was a small, non-randomized, non-controlled proof of concept study. Further work is required before this type of treatment could be adopted commonly or used of trial.
However, given its relatively benign nature and previous efficacy in treating other skin growths, hydrogen peroxide may represent a simple yet effective method at shrinking NMSC of the head and neck before they are excised or radiated. In doing so, it could minimize the invasiveness of surgical excision thereby accelerating healing and improving aesthetic outcomes for patients. If patients are being treated with radiation, we may be able to use smaller radiation fields with less side effects, better cosmesis and improved local control.
This double-blind placebo randomized controlled trial will seek to investigate the role of neoadjuvant hydrogen peroxide prior to definitive treatment with either surgery or radiation. For the purposes of this trial a concentration of 30% hydrogen peroxide will be used as this is the highest concentration easily available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30% hydrogen peroxide | Experimental | Drug: Hydrogen Peroxide 30 % Topical Solution30% 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. |
| 3% hydrogen peroxide | Placebo comparator | Drug: Hydrogen Peroxide 30 % Topical Solution3% 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen Peroxide 30 % Topical SolutionAlso: hydrogen peroxidePatients 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. | Drug | 3% hydrogen peroxide, 30% hydrogen peroxide |
Primary outcome
Change in lesion size
Time frame: 4 weeks after the last application of hydrogen peroxide
Reduction in lesion size, measured in square centimeter, 4 weeks after the last application of hydrogen peroxide.
6 secondary outcomes
Proportion of Patients with complete response
Time frame: At study completion, an approximate of 1 year
Proportion of patients requiring definitive surgery
Time frame: At study completion, an approximate of 1 year
Size of surgically removed skin
Time frame: At study completion, an approximate of 1 year
Change in the size of the radiation field
Time frame: At study completion, an approximate of 1 year
Local Control
Time frame: At study completion, an approximate of 1 year
Adverse Events
Time frame: At baseline, week 1, week 2, week 3, and also at 4 weeks after last hydrogen peroxide application. Adverse events will also be assessed at 3, 6, 9 and 12 months after the baseline visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinka Sathya, MD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrogen Peroxide 30 % Topical Solution in people with Basal Cell Carcinoma and Squamous Cell Carcinoma of Skin Differentiated, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robin Sachdeva, PhD (5196858500 ext. 54005, robin.sachdeva@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lesion size (time frame: 4 weeks after the last application of hydrogen peroxide). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.