N/A
N=74
Hypofractionated Radiotherapy in Breast Cancer
Cancer, Breast · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT03167359 ↗Enrolled (actual)
74
Serious AEs
4.1%
Results posted
May 2021
Primary outcome: Primary: Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4) — 60; 11; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypofractionated Simultaneous Integrated Boost Radiotherapy (Radiation)
- Age
- Pediatric, Adult
- Sex
- Female
- Sponsor
- Emory University
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4) |
60; 11; 0; 0; 0 | — |
| PRIMARY Number of Participants With 20% or Greater Increase in Arm Lymphedema Compared to Baseline |
— | — |
| PRIMARY Number of Participants With Grade 3 Brachial Plexopathy |
— | — |
| SECONDARY Change in Cutaneous Toxicity Rate Assessed by Ultrasound Tissue Characterizations (UTC) |
-0.91 | — |
| SECONDARY Change in Tumor Necrosis Factor (TNF) - Alpha Levels |
— | — |
| SECONDARY Change in Soluble TNF Receptor 2 (sTNFR2) Levels |
— | — |
| SECONDARY Change in Interleukin (IL)-6 Levels |
— | — |
| SECONDARY Change in Interleukin 1 Receptor Agonist (IL-1ra) Levels |
— | — |
| SECONDARY Change in C - Reactive Protein (CRP) Levels |
— | — |
| SECONDARY Change in Multidimensional Fatigue Inventory (MFI) Score |
-6.33 | — |
| SECONDARY Change in Pittsburgh Sleep Quality Index (PSQI) Score |
-0.75 | — |
| SECONDARY Change in Perceived Stress Scale (PSS) Score |
-2.92 | — |
| SECONDARY Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score |
-2.57 | — |
| SECONDARY Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) Score |
-3.21 | — |
| SECONDARY Change in Short Form-36 (SF-36) Health Survey Score |
11.07 | — |
| SECONDARY Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score |
5.21 | — |
| SECONDARY Change in Lent Soma Scale Patient Questionnaire Score |
-1.12 | — |
| SECONDARY Change in Breast Pain Level |
0.26 | — |
| SECONDARY Change in Breast Appearance Satisfaction Score |
.30 | — |
| SECONDARY Change in Radiated Breast Appearance Score |
-0.81 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03167359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.