Cancer, Breast, Inflammation
Conditions
Keywords
Psychiatry, Radiation Therapy
Brief summary
As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT. The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.
Detailed description
As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT. The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care. Investigators seek to assess the rate of cutaneous toxicity, the rates of lymphedema determined by arm measurements and Grade 3 brachial plexopathy in patients receiving regional nodal irradiation, as well as local control, quality of life, and fatigue levels.
Interventions
RADIATIONHypofractionated Simultaneous Integrated Boost Radiotherapy
Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 50 Years
Healthy volunteers
No
Inclusion criteria
Participants must have one or more of the following characteristics and be eligible for breast or chest wall with or without regional nodal radiotherapy: * Prior Chemotherapy for Breast Cancer * Greater than 25 cm of breast separation (the largest distance on an axial slice of the planning CT simulation scan between the entry and exit points of the radiation beam on the body) * Non-Caucasian Race * Less than or equal to 50 years of age * Requiring regional nodal irradiation without evidence of N3 disease
Exclusion criteria
* Males will be excluded * Women who are pregnant or nursing a child may not take part in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4) | Duration of Study (Up to 18 months) | Cutaneous toxicity rate will be assessed by the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) v.3 grading scale. THe NCI CTCAE grades go from 0 to 4. Grade 0: none. Grade 1: Mild or localized; topical intervention indicated. Grade 2: Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs. Grade 3-4: Severe or life-threatening. The higher the grade, the worse the outcome. |
| Number of Participants With 20% or Greater Increase in Arm Lymphedema Compared to Baseline | Duration of Study (Up to 18 months) | Number of Participants with 20% or greater increase in arm lymphedema (compared to baseline arm measurements) will be assessed among breast cancer patients receiving regional nodal irradiation. |
| Number of Participants With Grade 3 Brachial Plexopathy | Duration of Study (Up to 18 months) | Number of Participants with Grade 3 Brachial Plexopathy will be assessed among breast cancer patients receiving regional nodal irradiation by RTOG and LENT/SOMA scales Brachial plexopathy range minimum 0 and maximum 4. The higher the score, the worse the outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tumor Necrosis Factor (TNF) - Alpha Levels | Baseline, Post Intervention (Up to 18 Months) | Blood will be analyzed for TNF-alpha (TNF)-alpha levels and correlated to the development of cutaneous toxicity. |
| Change in Soluble TNF Receptor 2 (sTNFR2) Levels | Baseline, Post Intervention (Up to 18 Months) | Blood will be analyzed for soluble TNF receptor 2 (sTNFR2) levels and correlated to the development of cutaneous toxicity. |
| Change in Interleukin (IL)-6 Levels | Baseline, Post Intervention (Up to 18 Months) | Blood will be analyzed for interleukin (IL)-6 levels and correlated to the development of cutaneous toxicity. |
| Change in Multidimensional Fatigue Inventory (MFI) Score | Baseline, end of Follow Up (Up to 18 months) | The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. Scores range from 20 to 100.The higher the score, the more fatigued. The higher the maximum change, the greater increase in fatigue a patient feels. |
| Change in Pittsburgh Sleep Quality Index (PSQI) Score | Baseline, End of Follow Up (Up to 18 months) | The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Scores range from 0 to 21. A score of less than or equal to 5 is associated with good sleep quality. A score greater than 5 is associated with poor sleep quality. The higher the maximum change, the greater increase in sleep disturbances a patient has. |
| Change in Perceived Stress Scale (PSS) Score | Baseline, End of Follow Up (Up to 18 months) | The PSS is a self-reported instrument used to measure the perception of stress. Scores range from 0 to 40. Score of 20 or higher are considered high stress. The higher the maximum change, the greater increase in stress the patient feels. |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score | Baseline, End of Follow Up (Up to 18 months) | The PROMIS Fatigue questionnaire is a self-report tool used to evaluate frequency, duration, and intensity of fatigue over the past seven days. Scores range from 7 to 35. The higher the score, the more fatigue. |
| Change in Interleukin 1 Receptor Agonist (IL-1ra) Levels | Baseline, Post Intervention (Up to 18 Months) | Blood will be analyzed for IL-1ra levels and correlated to the development of cutaneous toxicity. |
| Change in Short Form-36 (SF-36) Health Survey Score | Baseline, End of Follow Up (Up to 18 months) | The SF-36 is a self-reported survey of health status. Scores range from 0 to 100. Lower scores indicate disability. The higher the score, the less disability. |
| Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score | Baseline, End of Follow Up (Up to 18 months) | The GLTEQ is a self-reported questionnaire used to measure usual leisure-time exercise habits during a typical seven day period. The GLTEQ specifically inquires about frequency of mild, moderate, and strenuous physical activity done during a typical 7-day period with exercise of more than 15 min or more per day during the previous week. Total score for the Godin leisure-time exercise questionnaire is calculated using this formula.Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). The GLTEQ total score can be broken into three categories: less than 14 points = sedentary 14 - 23 points is = moderately active 24 points or more = active The score ranges from 0 to 119. |
| Change in Lent Soma Scale Patient Questionnaire Score | Baseline, End of Follow Up (Up to 18 months) | The Lent Soma questionnaire is a self-reported measure of pain. Scores range from 0 to 9. The higher the score, the more pain reported.The higher the maximum change, the more increase in breast pain, the patient is perceiving. |
| Change in Breast Pain Level | Baseline, End of Follow Up (Up to 18 months) | Participants will be asked to rate their breast pain level on a study specific scale from 0 to 10 where 0 represents no pain, and 10 represents the most extreme pain. The higher the maximum change, the more increase in breast pain, the patient is perceiving. |
| Change in Breast Appearance Satisfaction Score | Baseline, End of Follow Up (Up to 18 months) | Participants will be asked to rate the look of their breast on a study specific scale from 0 to 10 where 0 represents not happy, and 10 represents very happy. The higher the maximum change, the more increase in happiness with breast appearance the patient is reporting. |
| Change in Radiated Breast Appearance Score | Baseline, End of Follow Up (Up to 18 months) | Participants will be asked to rate how different the look of their radiated breast is compared to their non-radiated breast on a study specific scale from 0 to 10 where 0 represents no difference, and 10 represents completely different. |
| Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) Score | Baseline, End of Follow Up (Up to 18 months) | The IDS-SR is a self-reported measure in which participants rate the frequency of depression symptoms within the past seven days. Scores range from 0 to 84, with higher score reflecting greater severity of depressive symptoms. |
| Change in C - Reactive Protein (CRP) Levels | Baseline, Post Intervention (Up to 18 Months) | Blood will be analyzed for CRP levels and correlated to the development of cutaneous toxicity. |
| Change in Cutaneous Toxicity Rate Assessed by Ultrasound Tissue Characterizations (UTC) | Baseline, end of Follow Up (Up to 18 months) (up to 18 months) | Ultrasound tissue characterization (UTC) is driven by knowledge of the physics of ultrasound and its interactions with biological tissue, and has traditionally used signal modelling and analysis to characterize and differentiate between healthy and diseased tissue. Change in mean UTC at last assessment (up to 18 months post XRT) was compared to baseline (pre-XRT) measures. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Stage 0-III Breast Cancer Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions. | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Participants With Stage 0-III Breast Cancer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 29 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 | 3 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment United States | 74 participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 74 |
| other Total, other adverse events | 0 / 74 |
| serious Total, serious adverse events | 3 / 74 |
Outcome results
Primary
Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)
Cutaneous toxicity rate will be assessed by the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) v.3 grading scale. THe NCI CTCAE grades go from 0 to 4. Grade 0: none. Grade 1: Mild or localized; topical intervention indicated. Grade 2: Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs. Grade 3-4: Severe or life-threatening. The higher the grade, the worse the outcome.
Time frame: Duration of Study (Up to 18 months)
Population: Data is missing on one participant who completed the study. Another patient developed a contralateral breast cancer during the study and another patient was lost to follow up. These latter two patients did not complete the 1 year post radiation assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4) | Grade 0 | 60 Participants |
| Participants With Stage 0-III Breast Cancer | Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4) | Grade 1 | 11 Participants |
| Participants With Stage 0-III Breast Cancer | Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4) | Grade 2 | 0 Participants |
| Participants With Stage 0-III Breast Cancer | Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4) | Grade 3 | 0 Participants |
| Participants With Stage 0-III Breast Cancer | Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4) | Grade 4 | 0 Participants |
Primary
Number of Participants With 20% or Greater Increase in Arm Lymphedema Compared to Baseline
Number of Participants with 20% or greater increase in arm lymphedema (compared to baseline arm measurements) will be assessed among breast cancer patients receiving regional nodal irradiation.
Time frame: Duration of Study (Up to 18 months)
Population: 30 patients received regional nodal irradiation, and per protocol, this subcohort of patients were assessed for lymphedema and brachial plexopathy. Patients who did not receive regional nodal irradiation did not undergo assessments for brachial plexopathy or lymphedema.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With Stage 0-III Breast Cancer | Number of Participants With 20% or Greater Increase in Arm Lymphedema Compared to Baseline | 0 Participants |
Primary
Number of Participants With Grade 3 Brachial Plexopathy
Number of Participants with Grade 3 Brachial Plexopathy will be assessed among breast cancer patients receiving regional nodal irradiation by RTOG and LENT/SOMA scales Brachial plexopathy range minimum 0 and maximum 4. The higher the score, the worse the outcome
Time frame: Duration of Study (Up to 18 months)
Population: Per protocol, only patients who received regional nodal irradiation were assessed for brachial plexopathy. 30 enrolled patients received regional nodal irradiation and then were assessed for brachial plexopath.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With Stage 0-III Breast Cancer | Number of Participants With Grade 3 Brachial Plexopathy | 0 Participants |
Secondary
Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) Score
The IDS-SR is a self-reported measure in which participants rate the frequency of depression symptoms within the past seven days. Scores range from 0 to 84, with higher score reflecting greater severity of depressive symptoms.
Time frame: Baseline, End of Follow Up (Up to 18 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) Score | -3.21 score on a scale | Standard Deviation 8.81 |
Secondary
Change in Breast Appearance Satisfaction Score
Participants will be asked to rate the look of their breast on a study specific scale from 0 to 10 where 0 represents not happy, and 10 represents very happy. The higher the maximum change, the more increase in happiness with breast appearance the patient is reporting.
Time frame: Baseline, End of Follow Up (Up to 18 months)
Population: This questionnaire was added in an amendment after the majority of patients were enrolled on study. Once the amendment was approved by Emory IRB, the questionnaire was administered to the remaining 33 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Change in Breast Appearance Satisfaction Score | .30 score on a scale | Standard Deviation 2.62 |
Secondary
Change in Breast Pain Level
Participants will be asked to rate their breast pain level on a study specific scale from 0 to 10 where 0 represents no pain, and 10 represents the most extreme pain. The higher the maximum change, the more increase in breast pain, the patient is perceiving.
Time frame: Baseline, End of Follow Up (Up to 18 months)
Population: This instrument was added in an amendment to the protocol after a number of patients had already been enrolled. Once approved, patients who were enrolled then completed the instrument at the corresponding timepoints after the amendment was approved.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Change in Breast Pain Level | 0.26 score on a scale | Standard Deviation 2.51 |
Secondary
Change in C - Reactive Protein (CRP) Levels
Blood will be analyzed for CRP levels and correlated to the development of cutaneous toxicity.
Time frame: Baseline, Post Intervention (Up to 18 Months)
Population: Specimens were not processed due to limited funds
Secondary
Change in Cutaneous Toxicity Rate Assessed by Ultrasound Tissue Characterizations (UTC)
Ultrasound tissue characterization (UTC) is driven by knowledge of the physics of ultrasound and its interactions with biological tissue, and has traditionally used signal modelling and analysis to characterize and differentiate between healthy and diseased tissue. Change in mean UTC at last assessment (up to 18 months post XRT) was compared to baseline (pre-XRT) measures.
Time frame: Baseline, end of Follow Up (Up to 18 months) (up to 18 months)
Population: One patient did not complete her ultrasound measurements of skin toxicity.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Change in Cutaneous Toxicity Rate Assessed by Ultrasound Tissue Characterizations (UTC) | -0.91 percentage change in skin thickness | Standard Deviation 0.39262 |
Secondary
Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score
The GLTEQ is a self-reported questionnaire used to measure usual leisure-time exercise habits during a typical seven day period. The GLTEQ specifically inquires about frequency of mild, moderate, and strenuous physical activity done during a typical 7-day period with exercise of more than 15 min or more per day during the previous week. Total score for the Godin leisure-time exercise questionnaire is calculated using this formula.Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). The GLTEQ total score can be broken into three categories: less than 14 points = sedentary 14 - 23 points is = moderately active 24 points or more = active The score ranges from 0 to 119.
Time frame: Baseline, End of Follow Up (Up to 18 months)
Population: This instrument was added to the protocol in an amendment and therefore the first two patients who were enrolled did not complete this instrument because they participated prior to approval of that amendment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score | 5.21 score on a scale | Standard Deviation 21.55 |
Secondary
Change in Interleukin 1 Receptor Agonist (IL-1ra) Levels
Blood will be analyzed for IL-1ra levels and correlated to the development of cutaneous toxicity.
Time frame: Baseline, Post Intervention (Up to 18 Months)
Population: Specimens were not processed due to limited funds
Secondary
Change in Interleukin (IL)-6 Levels
Blood will be analyzed for interleukin (IL)-6 levels and correlated to the development of cutaneous toxicity.
Time frame: Baseline, Post Intervention (Up to 18 Months)
Population: Specimens were not processed due to limited funds
Secondary
Change in Lent Soma Scale Patient Questionnaire Score
The Lent Soma questionnaire is a self-reported measure of pain. Scores range from 0 to 9. The higher the score, the more pain reported.The higher the maximum change, the more increase in breast pain, the patient is perceiving.
Time frame: Baseline, End of Follow Up (Up to 18 months)
Population: Per protocol, this questionnaire was administered only to patients who received regional nodal irradiation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Change in Lent Soma Scale Patient Questionnaire Score | -1.12 score on a scale | Standard Deviation 2.59 |
Secondary
Change in Multidimensional Fatigue Inventory (MFI) Score
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. Scores range from 20 to 100.The higher the score, the more fatigued. The higher the maximum change, the greater increase in fatigue a patient feels.
Time frame: Baseline, end of Follow Up (Up to 18 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Change in Multidimensional Fatigue Inventory (MFI) Score | -6.33 score on a scale | Standard Deviation 12.96 |
Secondary
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score
The PROMIS Fatigue questionnaire is a self-report tool used to evaluate frequency, duration, and intensity of fatigue over the past seven days. Scores range from 7 to 35. The higher the score, the more fatigue.
Time frame: Baseline, End of Follow Up (Up to 18 months)
Population: Patient were asked to complete this instrument only after an amendment was made to the protocol. Therefore, the last 23 patients enrolled completed this survey due to the fact that it was added to the protocol in after the majority of patients had been enrolled on the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score | -2.57 score on a scale | Standard Deviation 6.82 |
Secondary
Change in Perceived Stress Scale (PSS) Score
The PSS is a self-reported instrument used to measure the perception of stress. Scores range from 0 to 40. Score of 20 or higher are considered high stress. The higher the maximum change, the greater increase in stress the patient feels.
Time frame: Baseline, End of Follow Up (Up to 18 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Change in Perceived Stress Scale (PSS) Score | -2.92 score on a scale | Standard Deviation 6.99 |
Secondary
Change in Pittsburgh Sleep Quality Index (PSQI) Score
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Scores range from 0 to 21. A score of less than or equal to 5 is associated with good sleep quality. A score greater than 5 is associated with poor sleep quality. The higher the maximum change, the greater increase in sleep disturbances a patient has.
Time frame: Baseline, End of Follow Up (Up to 18 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Change in Pittsburgh Sleep Quality Index (PSQI) Score | -0.75 score on a scale | Standard Deviation 2.77 |
Secondary
Change in Radiated Breast Appearance Score
Participants will be asked to rate how different the look of their radiated breast is compared to their non-radiated breast on a study specific scale from 0 to 10 where 0 represents no difference, and 10 represents completely different.
Time frame: Baseline, End of Follow Up (Up to 18 months)
Population: This questionnaire was added as an amendment after the majority of patients had been enrolled and assessed. Once the amendment was Emory IRB approved, the questionnaire was administered to the remaining 31 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Change in Radiated Breast Appearance Score | -0.81 score on a scale | Standard Deviation 4.02 |
Secondary
Change in Short Form-36 (SF-36) Health Survey Score
The SF-36 is a self-reported survey of health status. Scores range from 0 to 100. Lower scores indicate disability. The higher the score, the less disability.
Time frame: Baseline, End of Follow Up (Up to 18 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Stage 0-III Breast Cancer | Change in Short Form-36 (SF-36) Health Survey Score | 11.07 score on a scale | Standard Deviation 15.89 |
Secondary
Change in Soluble TNF Receptor 2 (sTNFR2) Levels
Blood will be analyzed for soluble TNF receptor 2 (sTNFR2) levels and correlated to the development of cutaneous toxicity.
Time frame: Baseline, Post Intervention (Up to 18 Months)
Population: Specimens were not processed due to limited funds.
Secondary
Change in Tumor Necrosis Factor (TNF) - Alpha Levels
Blood will be analyzed for TNF-alpha (TNF)-alpha levels and correlated to the development of cutaneous toxicity.
Time frame: Baseline, Post Intervention (Up to 18 Months)
Population: Specimens were not processed due to limited funds