Trial Outcomes & Findings for Prone Breath Hold Technique to Decrease Cardiac and Pulmonary Doses in Women Receiving Left Breast Radiotherapy (NCT NCT02379988)
NCT ID: NCT02379988
Last Updated: 2023-05-17
Results Overview
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.
COMPLETED
NA
15 participants
Treatment Day 1 (both pFB and pDIBH scans were done on the same day)
2023-05-17
Participant Flow
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.
One patient who consented was deemed not eligible as she could not tolerate prone positioning
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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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|---|---|
|
Overall Study
Not eligible
|
1
|
Baseline Characteristics
Prone Breath Hold Technique to Decrease Cardiac and Pulmonary Doses in Women Receiving Left Breast Radiotherapy
Baseline characteristics by cohort
| Measure |
Verify Radiation Dose to Heart and Lung
n=14 Participants
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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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
|
Karnofsky performance status
|
100 Scores on a scale
n=5 Participants
|
|
Body Mass Index
|
30 kg/m^2
n=5 Participants
|
|
Pathologic tumor stage
Tis
|
4 Participants
n=5 Participants
|
|
Pathologic tumor stage
T1
|
10 Participants
n=5 Participants
|
|
Pathologic nodal stage
N0
|
9 Participants
n=5 Participants
|
|
Pathologic nodal stage
N0 (i+)
|
1 Participants
n=5 Participants
|
|
Pathologic nodal stage
None
|
4 Participants
n=5 Participants
|
|
Surgery
Conservative surgery + biopsy of sentinal node
|
10 Participants
n=5 Participants
|
|
Surgery
n/a
|
4 Participants
n=5 Participants
|
|
Histology
Ductal infiltrating carcinoma
|
9 Participants
n=5 Participants
|
|
Histology
Lobular infiltrating carcinoma
|
1 Participants
n=5 Participants
|
|
Histology
In-situ ductal carcinoma
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4 Participants
n=5 Participants
|
|
Tumor location
Upper Outer Quadrant (UOQ)
|
6 Participants
n=5 Participants
|
|
Tumor location
Upper Quadrant (UQ)
|
3 Participants
n=5 Participants
|
|
Tumor location
Upper Inner Quadrant (UIQ)
|
2 Participants
n=5 Participants
|
|
Tumor location
Lower Outer Quadrant (LOQ)
|
1 Participants
n=5 Participants
|
|
Tumor location
Lower Quadrant (LQ)
|
2 Participants
n=5 Participants
|
|
Oncotype
Yes
|
5 Participants
n=5 Participants
|
|
Oncotype
No
|
9 Participants
n=5 Participants
|
|
Estrogen/progesterone receptors
Positive
|
12 Participants
n=5 Participants
|
|
Estrogen/progesterone receptors
Negative
|
1 Participants
n=5 Participants
|
|
Estrogen/progesterone receptors
n/a
|
1 Participants
n=5 Participants
|
|
Ki67 proliferation index
|
16 Percentage of positive cells
n=5 Participants
|
|
Her2 neu immunohistochemistry
Positive
|
1 Participants
n=5 Participants
|
|
Her2 neu immunohistochemistry
Negative
|
10 Participants
n=5 Participants
|
|
Her2 neu immunohistochemistry
n/a
|
3 Participants
n=5 Participants
|
|
Anti-hormone therapy
Yes
|
11 Participants
n=5 Participants
|
|
Anti-hormone therapy
No
|
3 Participants
n=5 Participants
|
|
Anti-her2 neu therapy
Yes
|
1 Participants
n=5 Participants
|
|
Anti-her2 neu therapy
No
|
13 Participants
n=5 Participants
|
|
Neoadjuvant chemotherapy
Yes
|
1 Participants
n=5 Participants
|
|
Neoadjuvant chemotherapy
No
|
13 Participants
n=5 Participants
|
|
Adjuvant chemotherapy
Yes
|
1 Participants
n=5 Participants
|
|
Adjuvant chemotherapy
No
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Verify Radiation Dose to Heart and Lung
n=14 Participants
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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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
|
|
The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques.
Breath Holding Heart mean
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0.7186 Gy
Standard Deviation 11.43
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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
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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
|
|
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
|
|
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
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SECONDARY outcome
Timeframe: Treatment Day 1This 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.
Outcome measures
| Measure |
Verify Radiation Dose to Heart and Lung
n=14 Participants
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.
|
|---|---|
|
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
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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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Treatment Day 1Population: 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.
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.
Outcome measures
| Measure |
Verify Radiation Dose to Heart and Lung
n=14 Participants
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.
|
|---|---|
|
Heart Mean Dose Based on Breast Volume
Free breathing heart mean in smaller breast volume group
|
109.4 Gy
Standard Deviation 54.8
|
|
Heart Mean Dose Based on Breast Volume
Breath holding heart mean in smaller breast volume group
|
77.5 Gy
Standard Deviation 10.4
|
|
Heart Mean Dose Based on Breast Volume
Free breathing heart mean dose in larger breast volume group
|
71.6 Gy
Standard Deviation 8.1
|
|
Heart Mean Dose Based on Breast Volume
Breath hold heart mean dose in larger breast volume group
|
64.3 Gy
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Treatment Day 1This 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.
Outcome measures
| Measure |
Verify Radiation Dose to Heart and Lung
n=14 Participants
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.
|
|---|---|
|
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
|
|
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
|
Adverse Events
Verify Radiation Dose to Heart and Lung
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Victor Gonzalez
Peace Health St. Joseph's cancer center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place