Breast CancerNCT06006806
Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy
A study testing Pencil Beam Scanning Proton Therapy in people with Breast Cancer and Breast Cancer Stage II, run by Covenant Health Cancer Center at 1 site in United States.
Trial summary
This purpose of this study is to examine skin reactions (called radiation dermatitis) that occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique technique called "Spot Delete" to see if it can reduce skin reactions for breast patients treated with PBS. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III
- What is being tested?
- Pencil Beam Scanning Proton Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2023to 7 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must consent to be in the study and must have signed an approved consent form conforming to federal and institutional guidelines.
- Patients must be equal to or greater than 18 years old.
- The patient must have stage 0, I, II, or III breast cancer
- On histological examination, the tumor must be ductal carcinoma in-situ (DCIS) or invasive adenocarcinoma of the breast
- Surgical treatment of the breast must have been lumpectomy or mastectomy
- Patients must have an estrogen receptor (ER) analysis performed on the primary tumor
- Progesterone (PgR) analysis is desired but not mandatory
- No serious health conditions as determined by physician that would impact ability to complete treatment or impact skin in the area of treatment
Who cannot join
- Stage IV breast cancer
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Paget's disease of the nipple
- Prior breast or thoracic radiation therapy (RT) for any condition.
- Collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- Pregnancy or lactation
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thompson Proton Center
Knoxville, Tennessee, 37909
Casey Mastio-Partridge, BS, MLS, 865-331-8216, cmastio@covhlth.com
Jessica M Severt, RN, BSN, 865-331-4966, jsevert@covhlth.com
About this study
This purpose of this study is to examine skin reactions (called radiation dermatitis) that occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique technique called "Spot Delete" to see if it can reduce skin reactions for breast patients treated with PBS. They will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to these skin reactions. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body. The clinical team uses this CT scan to find the best placement for the protons. The "Spot Delete" method prevents protons from stopping in the skin, which is thought to cause skin redness.
Read the detailed description
During the study, digital photos of patients' skin will be taken to assess the amount of redness, without revealing their identity. Patients will be given a self-report questionnaire and medical staff will document the skin reactions in the patients' medical charts. The degree of skin reactions will be compared against historical occurrence rates, and the location of any skin reactions that occur will be compared against the predicted location from the computer model. In this study, we aim to test the hypothesis that the "Spot Delete" technique in proton therapy reduces radiation dermatitis in breast cancer patients compared to historical data from patients who underwent regular proton therapy without the technique. To evaluate this, we will compare the extent of skin reactions in patients who receive proton therapy with the "Spot Delete" technique to historical data from patients who did not receive this treatment.
The effectiveness of the technique will be evaluated by measuring and documenting the degree of skin reactions in patients undergoing proton therapy with the Spot Delete technique. Digital photographs of the treatment area will be taken to assess radiation dermatitis using the treatment using the Common Terminology Criteria for Adverse Events (CTCAE) ver. 5.0 and using the Radiation Dermatitis Severity (RDS) scoring system. Radiation dermatitis will be assessed at baseline, weekly after every fifth treatment session, at the end of treatment, and at 2 post treatment follow-up appointments (e.g. 1-month and 6-months post treatment).These results will be compared to historical occurrence rates of skin reactions in regular proton therapy.
- Being tested
- Pencil Beam Scanning Proton Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pencil Beam Scanning Proton TherapyRadiation
Also called Spot Delete
Part of the normal proton therapy process is to have a CT scan (called a CT simulation) performed that is used to create a proton treatment plan. A proton treatment plan is a computer model of the proton beam that is used to calculate where the protons will go inside the body. During the treatment planning process, the clinical team works to find the best possible placement of the protons. This study uses a process called "Spot Delete" to keep protons from stopping in the skin, which is believed to be related to skin reddening. Spot Delete is a software application that was developed at the Thompson Proton Center and is used in the treatment planning process.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Radiation Dermatitis
"Spot Delete" technique in proton therapy reduces radiation dermatitis in breast cancer patients compared to historical data from patients who underwent regular proton therapy without the technique. Assessed by photographs, questionnaires and assessment using CTCAE and Radiation Dermatitis Severity scoring system.
Measured: weekly assessments over 10 weeks
Secondary outcomes (1)
linear energy transfer (LET) of the proton beam
A secondary objective of this study is to investigate how the linear energy transfer (LET) of the proton beam is related to skin reactions. , LET will be calculated using RayStation for each patient enrolled in the study. The skin reactions' location and severity will be compared with the calculated LET values, allowing researchers to determine any correlation between LET and skin reactions. In addition, the actual location of any skin reactions that occur during the study will be compared to the predicted location from the computer model
Measured: LET calculated at treatment completion for each subject and then compared over the 10 weeks of assessment if radiation dermatitis or other skin reaction is reported. At that time data will be compared.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start7 Jul 2023
- Primary completion7 Jul 2028 (estimated)
- Study completion7 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The goal of this study is to measure skin reactions during proton therapy for 100 patients over a period of three years.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Covenant Health Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samantha Hedrick, PhD, Principal investigator, Director of Medical Physics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006806
- Sponsor's protocol ID
- 2023-474 INV
- Status last verified
- Apr 2025
- First submitted
- 14 Aug 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Radiobiological Effects in Skin Toxicities for Breast Cancer Patients With Pencil Beam Scanning Proton Therapy
- ClinicalTrials.gov ID
- NCT06006806
- Acronym / sponsor ID
- 2023-474 INV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Covenant Health Cancer CenterUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 7 Jul 2028 (estimated)
- Study completion
- 7 Jul 2030 (estimated)
- First posted
- 23 Aug 2023 (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.
This purpose of this study is to examine skin reactions (called radiation dermatitis) that occur during pencil beam scanning (PBS) proton therapy. The researchers will test a unique technique called "Spot Delete" to see if it can reduce skin reactions for breast patients treated with PBS. They will also use a special computer model to study how the energy of the proton beam (linear energy transfer) is related to these skin reactions. The study involves creating a treatment plan based on a CT scan, which helps guide the proton beam in the body. The clinical team uses this CT scan to find the best placement for the protons. The "Spot Delete" method prevents protons from stopping in the skin, which is thought to cause skin redness.
Detailed description
During the study, digital photos of patients' skin will be taken to assess the amount of redness, without revealing their identity. Patients will be given a self-report questionnaire and medical staff will document the skin reactions in the patients' medical charts. The degree of skin reactions will be compared against historical occurrence rates, and the location of any skin reactions that occur will be compared against the predicted location from the computer model. In this study, we aim to test the hypothesis that the "Spot Delete" technique in proton therapy reduces radiation dermatitis in breast cancer patients compared to historical data from patients who underwent regular proton therapy without the technique. To evaluate this, we will compare the extent of skin reactions in patients who receive proton therapy with the "Spot Delete" technique to historical data from patients who did not receive this treatment.
The effectiveness of the technique will be evaluated by measuring and documenting the degree of skin reactions in patients undergoing proton therapy with the Spot Delete technique. Digital photographs of the treatment area will be taken to assess radiation dermatitis using the treatment using the Common Terminology Criteria for Adverse Events (CTCAE) ver. 5.0 and using the Radiation Dermatitis Severity (RDS) scoring system. Radiation dermatitis will be assessed at baseline, weekly after every fifth treatment session, at the end of treatment, and at 2 post treatment follow-up appointments (e.g. 1-month and 6-months post treatment).These results will be compared to historical occurrence rates of skin reactions in regular proton therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- The goal of this study is to measure skin reactions during proton therapy for 100 patients over a period of three years.
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient must consent to be in the study and must have signed an approved consent form conforming to federal and institutional guidelines.
- Patients must be equal to or greater than 18 years old.
- The patient must have stage 0, I, II, or III breast cancer
- On histological examination, the tumor must be ductal carcinoma in-situ (DCIS) or invasive adenocarcinoma of the breast
- Surgical treatment of the breast must have been lumpectomy or mastectomy
Key exclusion criteria (7 listed)
- Stage IV breast cancer
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Paget's disease of the nipple
- Prior breast or thoracic radiation therapy (RT) for any condition.
- Collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
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 |
|---|---|---|
| Pencil Beam Scanning Proton TherapyAlso: Spot DeletePart of the normal proton therapy process is to have a CT scan (called a CT simulation) performed that is used to create a proton treatment plan. A proton treatment plan is a computer model of the proton beam that is used to calculate where the protons will go inside the body. During the treatment planning process, the clinical team works to find the best possible placement of the protons. This study uses a process called "Spot Delete" to keep protons from stopping in the skin, which is believed to be related to skin reddening. Spot Delete is a software application that was developed at the Thompson Proton Center and is used in the treatment planning process. | Radiation | – |
Primary outcome
Reduction in Radiation Dermatitis
Time frame: weekly assessments over 10 weeks
"Spot Delete" technique in proton therapy reduces radiation dermatitis in breast cancer patients compared to historical data from patients who underwent regular proton therapy without the technique. Assessed by photographs, questionnaires and assessment using CTCAE and Radiation Dermatitis Severity scoring system.
1 secondary outcome
linear energy transfer (LET) of the proton beam
Time frame: LET calculated at treatment completion for each subject and then compared over the 10 weeks of assessment if radiation dermatitis or other skin reaction is reported. At that time data will be compared.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- 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.
Samantha Hedrick, PhD principal investigator
Director of Medical Physics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pencil Beam Scanning Proton Therapy in people with Breast Cancer and Breast Cancer Stage II, run by Covenant Health Cancer Center at 1 site in United States.
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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 Apr 2025. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Hedrick (865-862-1600, shedrick@covhlth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Radiation Dermatitis (time frame: weekly assessments over 10 weeks). 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 8 Apr 2025.