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This is a pilot study to determine whether the addition of inspiratory hold (breath holding) can decrease the radiation dose that the heart and lung receive for patients being treated for left sided breast cancer.
Subjects have a standard of care CT simulation, which includes an additional breath hold CT. Inspiratory gated breath-hold will be used. Two radiation plans will be generated: one for the CT scan performed free breathing, and one for the CT scan performed with inspiratory gated breath hold. The cardiac and lung doses will be determined. At the discretion of the treating physician, the plan with the lower cardiac and lung dose may be used to treat the patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verify radiation dose to heart and lung | Experimental | Subjects will undergo the standard of care CT simulation, which includes an additional breath hold CT. Inspiratory gated breath-hold will be used. Two radiation plans will be generated: one for the CT scan performed free breathing, and one for the CT scan performed with inspiratory gated breath hold. The cardiac and lung doses will be determined. At the discretion of the treating physician, the plan with the lower cardiac and lung dose may be used to treat the patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verify radiation dose to heart and lung | Radiation | This is a pilot study to determine whether the addition of inspiratory hold (breath holding) can decrease the radiation dose that the heart and lung receives for patients being treated for left sided breast cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques. | The primary endpoints of this study were to evaluate the feasibility of the combination of prone positioning and RPM pDIPH for breast cancer radiation treatment. Each woman enrolled in the study had 2 radiation plans generated: one for the pFB scan and one for the pDIBH scan. The mean difference between the dosimetrically determined heart, left anterior descending (LAD) artery, and left lung radiation doses were computed with the associated 95% confidence interval; however, the Wilcoxin paired signed rank test was used and listed below as the primary analysis because of the non-normal distributions. | Treatment Day 1 (both pFB and pDIBH scans were done on the same day) |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Cardiac Dose and Lung Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. | This outcome was measured by looking at the maximum dose to the heart and maximum dose to the left lung in patients using the free breathing method versus the breath holding method in the prone position. The mean of the maximum doses for each patient was taken and compared using the Wilcoxin Paired Signed Rank Test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor J Gonzalez, MD | University of Arizona Radiation Oncology | Principal Investigator |
| Uma Goyal, MD | University of Arizona Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiation Oncology Department at the University of Arizona Heath Network | Tucson | Arizona | 85724-5024 | United States |
One patient who consented was deemed not eligible as she could not tolerate prone positioning
From 2014 to 2016, 15 women with left-sided breast cancer were enrolled from the University of Arizona Cancer Center clinic. One was excluded from the final analysis because she did not tolerate prone positioning at the time of simulation, leaving 14 patients with evaluable pFB and pDIBH scans.
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| ID | Title | Description |
|---|---|---|
| FG000 | Verify Radiation Dose to Heart and Lung | Subjects will undergo the standard of care CT simulation, which includes an additional breath hold CT. Inspiratory gated breath-hold will be used. Two radiation plans will be generated: one for the CT scan performed free breathing, and one for the CT scan performed with inspiratory gated breath hold. The cardiac and lung doses will be determined. At the discretion of the treating physician, the plan with the lower cardiac and lung dose may be used to treat the patient. Verify radiation dose to heart and lung: This is a pilot study to determine whether the addition of inspiratory hold (breath holding) can decrease the radiation dose that the heart and lung receives for patients being treated for left sided breast cancer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Verify Radiation Dose to Heart and Lung | Subjects will undergo the standard of care CT simulation, which includes an additional breath hold CT. Inspiratory gated breath-hold will be used. Two radiation plans will be generated: one for the CT scan performed free breathing, and one for the CT scan performed with inspiratory gated breath hold. The cardiac and lung doses will be determined. At the discretion of the treating physician, the plan with the lower cardiac and lung dose may be used to treat the patient. Verify radiation dose to heart and lung: This is a pilot study to determine whether the addition of inspiratory hold (breath holding) can decrease the radiation dose that the heart and lung receives for patients being treated for left sided breast cancer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques. | The primary endpoints of this study were to evaluate the feasibility of the combination of prone positioning and RPM pDIPH for breast cancer radiation treatment. Each woman enrolled in the study had 2 radiation plans generated: one for the pFB scan and one for the pDIBH scan. The mean difference between the dosimetrically determined heart, left anterior descending (LAD) artery, and left lung radiation doses were computed with the associated 95% confidence interval; however, the Wilcoxin paired signed rank test was used and listed below as the primary analysis because of the non-normal distributions. | Posted | Mean | Standard Deviation | Gy | Treatment Day 1 (both pFB and pDIBH scans were done on the same day) |
|
Adverse event collection was done through the 1 year follow-up period. It should be noted though that all adverse events recorded were in relation to the radiation therapy itself and not the study intervention of deep inspiratory breath-hold (DIBH) during prone breast RT.
The intervention for this trial is a breathing technique and does not pose any risk to the patient. No adverse events were recorded in relation to the study intervention itself.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Verify Radiation Dose to Heart and Lung | Subjects will undergo the standard of care CT simulation, which includes an additional breath hold CT. Inspiratory gated breath-hold will be used. Two radiation plans will be generated: one for the CT scan performed free breathing, and one for the CT scan performed with inspiratory gated breath hold. The cardiac and lung doses will be determined. At the discretion of the treating physician, the plan with the lower cardiac and lung dose may be used to treat the patient. Verify radiation dose to heart and lung: This is a pilot study to determine whether the addition of inspiratory hold (breath holding) can decrease the radiation dose that the heart and lung receives for patients being treated for left sided breast cancer. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victor Gonzalez | Peace Health St. Joseph's cancer center | 360-788-8222 | vgonzalez1@peachehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2015 | Dec 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Treatment Day 1 |
| Heart Mean Dose Based on Breast Volume | The breast volume was evaluated using the dose-volume histogram. A paired t-test was used to assess if breast volume and the mean difference for heart was statistically significant. Because paired data were generated the number of women required was less than if 2 independent samples of women were to be used. | Treatment Day 1 |
| Determination of Left Anterior Artery (LAD) Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. | This outcome was measured by looking at the maximum dose to the LAD in patients using the free breathing method versus the breath holding method in the prone position. The mean of the maximum doses for each patient was taken and compared using the Wilcoxin Paired Signed Rank Test. | Treatment Day 1 |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Karnofsky performance status | The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. | Median | Full Range | Scores on a scale |
|
| Body Mass Index | Mean | Full Range | kg/m^2 |
|
| Pathologic tumor stage | Tumor staging was done pathologically using a combination of clinical information and pathologic examination. Tis = stage 0; T1 refers to the size and/or extent of the main tumor (higher numbers after T indicates larger tumors and/or growth into nearby tissues). | Count of Participants | Participants |
|
| Pathologic nodal stage | Only patients with node-negative left breast cancer were eligible to participate as indicated by the pathologi nodal stage, N0. For N0 (i+), the abbreviation "i+" means that a small number of cancer cells were seen in routine stains or when a special type of staining technique, called immunohistochemistry, was used. | Count of Participants | Participants |
|
| Surgery | Count of Participants | Participants |
|
| Histology | Count of Participants | Participants |
|
| Tumor location | Count of Participants | Participants |
|
| Oncotype | Number of patients where Oncotype (predict whether breast cancer will spread or come back) was assessed (yes) versus not assessed (no). | Count of Participants | Participants |
|
| Estrogen/progesterone receptors | Count of Participants | Participants |
|
| Ki67 proliferation index | Mean | Full Range | Percentage of positive cells |
|
| Her2 neu immunohistochemistry | Count of Participants | Participants |
|
| Anti-hormone therapy | Count of Participants | Participants |
|
| Anti-her2 neu therapy | Count of Participants | Participants |
|
| Neoadjuvant chemotherapy | Count of Participants | Participants |
|
| Adjuvant chemotherapy | Count of Participants | Participants |
|
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| Secondary | Determination of Cardiac Dose and Lung Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. | This outcome was measured by looking at the maximum dose to the heart and maximum dose to the left lung in patients using the free breathing method versus the breath holding method in the prone position. The mean of the maximum doses for each patient was taken and compared using the Wilcoxin Paired Signed Rank Test. | Posted | Mean | Standard Deviation | Gy | Treatment Day 1 |
|
|
|
|
| Secondary | Heart Mean Dose Based on Breast Volume | The breast volume was evaluated using the dose-volume histogram. A paired t-test was used to assess if breast volume and the mean difference for heart was statistically significant. Because paired data were generated the number of women required was less than if 2 independent samples of women were to be used. | The mean breast volume in the group was measured and then split into 2 groups based on breast volume, a smaller group (8), and a larger group (6). The mean breast volume was 2028.92 cc. The smaller breast volume group was less than or equal to 2028.92 cc. The larger breast volume group was >2028.92 cc. | Posted | Mean | Standard Deviation | Gy | Treatment Day 1 |
|
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|
|
| Secondary | Determination of Left Anterior Artery (LAD) Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. | This outcome was measured by looking at the maximum dose to the LAD in patients using the free breathing method versus the breath holding method in the prone position. The mean of the maximum doses for each patient was taken and compared using the Wilcoxin Paired Signed Rank Test. | Posted | Mean | Standard Deviation | Gy | Treatment Day 1 |
|
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| Lung max breath holding |
|
| =0.0110 |
P-value for Lung Max Free breathing and Breath Hold |
| Equivalence |
The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions. |
|
| Free breathing heart mean dose in larger breast volume group |
|
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| Breath hold heart mean dose in larger breast volume group |
|
|
P-value for Small breast volume group |
| Equivalence |
Paired T-test |