Radiation Toxicity
Conditions
Brief summary
This study involves women who have had a diagnosis of breast cancer, and have had a lumpectomy with radiation treatments completed in the past year. The study will determine the level of oxygen in the skin of the breast that has been radiated, compared with the normal skin of the opposite breast. The purpose of this study is to determine if there is a decrease in oxygen levels in the skin which has been radiated, hopefully to find a treatment to limit skin damage caused by radiation treatments, for women with breast cancer in the future.
Detailed description
Successful completion of this study will provide data on changes in oxygenation in irradiated tissues. If changes are documented, this study would provide evidence supporting current models of tissue injury following radiotherapy. In addition, these data may provide a mechanistic rationale for clinical approaches to ameliorate the toxicities of radiotherapy. Finally, if a correlation exists between tissue oxygenation and toxicity, the rapid and simple tissue oxygenation test may provide a quantitative measure of toxicity and allow earlier and more precise assessment of both toxicity and efficacy of ameliorative therapies.
Interventions
None listed
Sponsors
Essentia Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Diagnosis of breast malignancy 2. Completion of breast irradiation one year (+/- 8 weeks) prior. 3. Surgical treatment with lumpectomy
Exclusion criteria
1. Inability to tolerate the 20 minute transcutaneous oxygenation measurements 2. Allergy to adhesives 3. Bilateral disease or absence of control breast or previous radiotherapy to control breast 4. More than one course of radiotherapy to the breast
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Oxygenation | One visit for 20 minutes | Transcutaneous oxygen detector is used to measure the partial pressure of oxygen. The unit detects electrolytes ionized by oxygen. The measuring electrode also heats the skin being measured to facilitate maximal bloodflow to the area. |
Secondary
| Measure | Time frame |
|---|---|
| Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured. | One visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects patients were invited to participate one year after completing radiotherapy as part of their treatment for breast preservation cancer treatment | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 63 years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
| tissue oxygenation of nontreated breast | 66.3 mmHg STANDARD_DEVIATION 22.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Tissue Oxygenation
Transcutaneous oxygen detector is used to measure the partial pressure of oxygen. The unit detects electrolytes ionized by oxygen. The measuring electrode also heats the skin being measured to facilitate maximal bloodflow to the area.
Time frame: One visit for 20 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects | Tissue Oxygenation | 62.5 mmHg | Standard Deviation 18.4 |
p-value: 0.5t-test, 2 sided
p-value: 0.5t-test, 2 sided
Secondary
Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured.
Time frame: One visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects | Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured. | late subcutaneous toxicitiy score 1 | 19 Participants |
| Subjects | Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured. | late skin toxicity score 1 | 19 Participants |
| Subjects | Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured. | late skin toxicity score 2 | 1 Participants |
| Subjects | Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured. | late subcutaneous toxcity score 2 | 1 Participants |