Cancer, BreastNCT03167359
Hypofractionated Radiotherapy in Breast Cancer
A study testing Hypofractionated Simultaneous Integrated Boost Radiotherapy in people with Cancer, Breast and Inflammation, run by Emory University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 50 years, women only
- Conditions the study is for
- Cancer, Breast, Inflammation
- What is being tested?
- Hypofractionated Simultaneous Integrated Boost Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to 14 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Males will be excluded
- Women who are pregnant or nursing a child may not take part in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Hypofractionated Simultaneous Integrated Boost Radiotherapy in Stage 0, I and III Breast Cancer Patients
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.
Read the 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.
- Conditions
- Cancer, Breast, Inflammation
- Being tested
- Hypofractionated Simultaneous Integrated Boost Radiotherapy
- Keywords
- Psychiatry, Radiation Therapy
- Medical subject headings
- Breast Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Simultaneous Integrated Boost RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Stage 0-III breast cancer | Experimental | 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. Receives: Radiation: Hypofractionated Simultaneous Integrated Boost Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of Study (Up to 18 months)
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.
Measured: Duration of Study (Up to 18 months)
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
Measured: Duration of Study (Up to 18 months)
Secondary outcomes (17)
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.
Measured: Baseline, end of Follow Up (Up to 18 months) (up to 18 months)
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.
Measured: Baseline, Post Intervention (Up to 18 Months)
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.
Measured: Baseline, Post Intervention (Up to 18 Months)
Change in Interleukin (IL)-6 Levels
Blood will be analyzed for interleukin (IL)-6 levels and correlated to the development of cutaneous toxicity.
Measured: Baseline, Post Intervention (Up to 18 Months)
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.
Measured: Baseline, Post Intervention (Up to 18 Months)
Change in C - Reactive Protein (CRP) Levels
Blood will be analyzed for CRP levels and correlated to the development of cutaneous toxicity.
Measured: Baseline, Post Intervention (Up to 18 Months)
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.
Measured: Baseline, end of Follow Up (Up to 18 months)
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.
Measured: Baseline, End of Follow Up (Up to 18 months)
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.
Measured: Baseline, End of Follow Up (Up to 18 months)
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.
Measured: Baseline, End of Follow Up (Up to 18 months)
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.
Measured: Baseline, End of Follow Up (Up to 18 months)
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.
Measured: Baseline, End of Follow Up (Up to 18 months)
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.
Measured: Baseline, End of Follow Up (Up to 18 months)
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.
Measured: Baseline, End of Follow Up (Up to 18 months)
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.
Measured: Baseline, End of Follow Up (Up to 18 months)
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.
Measured: Baseline, End of Follow Up (Up to 18 months)
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.
Measured: Baseline, End of Follow Up (Up to 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startDec 2010
- Primary completion14 May 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mylin Torres, MD, Emory University
- Investigators
- Mylin Torres, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167359
- Sponsor's protocol ID
- IRB00047240
- Status last verified
- May 2021
- First submitted
- 24 May 2017
- Last updated
- 7 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Hypofractionated Simultaneous Integrated Boost Radiotherapy in Stage 0, I and III Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03167359
- Acronym / sponsor ID
- IRB00047240
- Conditions
- Cancer, Breast, Inflammation
- Keywords
- Psychiatry, Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 7 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Stage 0-III breast cancer | Experimental | Radiation: Hypofractionated Simultaneous Integrated Boost RadiotherapyWomen 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. |
Who may qualify
- Ages
- Up to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Males will be excluded
- Women who are pregnant or nursing a child may not take part in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated Simultaneous Integrated Boost RadiotherapyParticipants 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. | Radiation | Participants with Stage 0-III breast cancer |
Primary outcome
Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)
Time frame: 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
Time frame: 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
Time frame: 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
17 secondary outcomes
Change in Cutaneous Toxicity Rate Assessed by Ultrasound Tissue Characterizations (UTC)
Time frame: Baseline, end of Follow Up (Up to 18 months) (up to 18 months)
Change in Tumor Necrosis Factor (TNF) - Alpha Levels
Time frame: Baseline, Post Intervention (Up to 18 Months)
Change in Soluble TNF Receptor 2 (sTNFR2) Levels
Time frame: Baseline, Post Intervention (Up to 18 Months)
Change in Interleukin (IL)-6 Levels
Time frame: Baseline, Post Intervention (Up to 18 Months)
Change in Interleukin 1 Receptor Agonist (IL-1ra) Levels
Time frame: Baseline, Post Intervention (Up to 18 Months)
Change in C - Reactive Protein (CRP) Levels
Time frame: Baseline, Post Intervention (Up to 18 Months)
Change in Multidimensional Fatigue Inventory (MFI) Score
Time frame: Baseline, end of Follow Up (Up to 18 months)
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline, End of Follow Up (Up to 18 months)
Change in Perceived Stress Scale (PSS) Score
Time frame: Baseline, End of Follow Up (Up to 18 months)
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score
Time frame: Baseline, End of Follow Up (Up to 18 months)
Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) Score
Time frame: Baseline, End of Follow Up (Up to 18 months)
Change in Short Form-36 (SF-36) Health Survey Score
Time frame: Baseline, End of Follow Up (Up to 18 months)
Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score
Time frame: Baseline, End of Follow Up (Up to 18 months)
Change in Lent Soma Scale Patient Questionnaire Score
Time frame: Baseline, End of Follow Up (Up to 18 months)
Change in Breast Pain Level
Time frame: Baseline, End of Follow Up (Up to 18 months)
Change in Breast Appearance Satisfaction Score
Time frame: Baseline, End of Follow Up (Up to 18 months)
Change in Radiated Breast Appearance Score
Time frame: Baseline, End of Follow Up (Up to 18 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Cancer, Breast
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mylin Torres, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Simultaneous Integrated Boost Radiotherapy in people with Cancer, Breast and Inflammation, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4) (time frame: Duration of Study (Up to 18 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.