Breast Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONVerify 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.
Sponsors
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of Dr. Gonzalez * ≥18 years of age * Node-negative left breast cancer * Invasive or DCIS breast cancer * Prior lumpectomy * Deemed appropriate for treatment in the prone position by the treating physician * Able to tolerate prone position and breath hold during CT simulation
Exclusion criteria
* \<18 years of age * Patients requiring treatment in supine position
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques. | Treatment Day 1 (both pFB and pDIBH scans were done on the same day) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Mean Dose Based on Breast Volume | Treatment Day 1 | 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. |
| Determination of Cardiac Dose and Lung Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. | Treatment Day 1 | 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. |
| Determination of Left Anterior Artery (LAD) Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. | Treatment Day 1 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
One patient who consented was deemed not eligible as she could not tolerate prone positioning
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not eligible | 1 |
Baseline characteristics
| Characteristic | Verify Radiation Dose to Heart and Lung |
|---|---|
| Adjuvant chemotherapy No | 13 Participants |
| Adjuvant chemotherapy Yes | 1 Participants |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 58 years |
| Anti-her2 neu therapy No | 13 Participants |
| Anti-her2 neu therapy Yes | 1 Participants |
| Anti-hormone therapy No | 3 Participants |
| Anti-hormone therapy Yes | 11 Participants |
| Body Mass Index | 30 kg/m^2 |
| Estrogen/progesterone receptors n/a | 1 Participants |
| Estrogen/progesterone receptors Negative | 1 Participants |
| Estrogen/progesterone receptors Positive | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Her2 neu immunohistochemistry n/a | 3 Participants |
| Her2 neu immunohistochemistry Negative | 10 Participants |
| Her2 neu immunohistochemistry Positive | 1 Participants |
| Histology Ductal infiltrating carcinoma | 9 Participants |
| Histology In-situ ductal carcinoma | 4 Participants |
| Histology Lobular infiltrating carcinoma | 1 Participants |
| Karnofsky performance status | 100 Scores on a scale |
| Ki67 proliferation index | 16 Percentage of positive cells |
| Neoadjuvant chemotherapy No | 13 Participants |
| Neoadjuvant chemotherapy Yes | 1 Participants |
| Oncotype No | 9 Participants |
| Oncotype Yes | 5 Participants |
| Pathologic nodal stage N0 | 9 Participants |
| Pathologic nodal stage N0 (i+) | 1 Participants |
| Pathologic nodal stage None | 4 Participants |
| Pathologic tumor stage T1 | 10 Participants |
| Pathologic tumor stage Tis | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
| Surgery Conservative surgery + biopsy of sentinal node | 10 Participants |
| Surgery n/a | 4 Participants |
| Tumor location Lower Outer Quadrant (LOQ) | 1 Participants |
| Tumor location Lower Quadrant (LQ) | 2 Participants |
| Tumor location Upper Inner Quadrant (UIQ) | 2 Participants |
| Tumor location Upper Outer Quadrant (UOQ) | 6 Participants |
| Tumor location Upper Quadrant (UQ) | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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.
Time frame: Treatment Day 1 (both pFB and pDIBH scans were done on the same day)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Verify Radiation Dose to Heart and Lung | The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques. | Free breathing Heart Mean | 0.9317 Gy | Standard Deviation 44.96 |
| Verify Radiation Dose to Heart and Lung | The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques. | Breath Holding Heart mean | 0.7186 Gy | Standard Deviation 11.43 |
| Verify Radiation Dose to Heart and Lung | The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques. | Free breathing Lung mean | 0.6523 Gy | Standard Deviation 52.78 |
| Verify Radiation Dose to Heart and Lung | The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques. | Breath Holding Lung mean | 0.8746 Gy | Standard Deviation 44.81 |
| Verify Radiation Dose to Heart and Lung | The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques. | Free breathing LAD mean | 2.6159 Gy | Standard Deviation 270.58 |
| Verify Radiation Dose to Heart and Lung | The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques. | Breath holding LAD mean | 2.6231 Gy | Standard Deviation 254.61 |
p-value: =0.0063Wilcoxon (Mann-Whitney)
p-value: =0.011Wilcoxon (Mann-Whitney)
p-value: =0.5098Wilcoxon (Mann-Whitney)
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.
Time frame: Treatment Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Verify Radiation Dose to Heart and Lung | Determination of Cardiac Dose and Lung Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. | Heart Max free breathing | 15.7029 Gy | Standard Deviation 1424.78 |
| Verify Radiation Dose to Heart and Lung | Determination of Cardiac Dose and Lung Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. | Heart Max breath hold | 7.1869 Gy | Standard Deviation 688.47 |
| Verify Radiation Dose to Heart and Lung | Determination of Cardiac Dose and Lung Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. | Lung max free breathing | 17.9426 Gy | Standard Deviation 1588.08 |
| Verify Radiation Dose to Heart and Lung | Determination of Cardiac Dose and Lung Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. | Lung max breath holding | 26.6156 Gy | Standard Deviation 1392.71 |
p-value: =0.001Wilcoxon (Mann-Whitney)
p-value: =0.011Wilcoxon (Mann-Whitney)
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.
Time frame: Treatment Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Verify Radiation Dose to Heart and Lung | Determination of Left Anterior Artery (LAD) Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. | Free breathing LAD max | 9.9154 Gy | Standard Deviation 1166.83 |
| Verify Radiation Dose to Heart and Lung | Determination of Left Anterior Artery (LAD) Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. | Breath holding LAD max | 8.3896 Gy | Standard Deviation 1108.48 |
p-value: =0.7776Wilcoxon (Mann-Whitney)
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.
Time frame: Treatment Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Verify Radiation Dose to Heart and Lung | Heart Mean Dose Based on Breast Volume | Free breathing heart mean in smaller breast volume group | 109.4 Gy | Standard Deviation 54.8 |
| Verify Radiation Dose to Heart and Lung | Heart Mean Dose Based on Breast Volume | Breath holding heart mean in smaller breast volume group | 77.5 Gy | Standard Deviation 10.4 |
| Verify Radiation Dose to Heart and Lung | Heart Mean Dose Based on Breast Volume | Free breathing heart mean dose in larger breast volume group | 71.6 Gy | Standard Deviation 8.1 |
| Verify Radiation Dose to Heart and Lung | Heart Mean Dose Based on Breast Volume | Breath hold heart mean dose in larger breast volume group | 64.3 Gy | Standard Deviation 8.2 |
p-value: =0.01Paired T-test
p-value: =0.1Paired T-test