Clinical trial NCT03167359: Hypofractionated Radiotherapy in Breast Cancer
Official title: A Pilot Study of Hypofractionated Simultaneous Integrated Boost Radiotherapy in Stage 0, I and III Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Breast
Inflammation
Keywords: Psychiatry
Radiation Therapy
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 74
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)
timeFrame: Duration of Study (Up to 18 months)
measure: Number of Participants With 20% or Greater Increase in Arm Lymphedema Compared to Baseline
timeFrame: Duration of Study (Up to 18 months)
measure: Number of Participants With Grade 3 Brachial Plexopathy
timeFrame: Duration of Study (Up to 18 months)
Secondary outcomes:
measure: Change in Cutaneous Toxicity Rate Assessed by Ultrasound Tissue Characterizations (UTC)
timeFrame: Baseline, end of Follow Up (Up to 18 months) (up to 18 months)
measure: Change in Tumor Necrosis Factor (TNF) - Alpha Levels
timeFrame: Baseline, Post Intervention (Up to 18 Months)
measure: Change in Soluble TNF Receptor 2 (sTNFR2) Levels
timeFrame: Baseline, Post Intervention (Up to 18 Months)
measure: Change in Interleukin (IL)-6 Levels
timeFrame: Baseline, Post Intervention (Up to 18 Months)
measure: Change in Interleukin 1 Receptor Agonist (IL-1ra) Levels
timeFrame: Baseline, Post Intervention (Up to 18 Months)
measure: Change in C - Reactive Protein (CRP) Levels
timeFrame: Baseline, Post Intervention (Up to 18 Months)
measure: Change in Multidimensional Fatigue Inventory (MFI) Score
timeFrame: Baseline, end of Follow Up (Up to 18 months)
measure: Change in Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: Baseline, End of Follow Up (Up to 18 months)
measure: Change in Perceived Stress Scale (PSS) Score
timeFrame: Baseline, End of Follow Up (Up to 18 months)
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score
timeFrame: Baseline, End of Follow Up (Up to 18 months)
measure: Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) Score
timeFrame: Baseline, End of Follow Up (Up to 18 months)
measure: Change in Short Form-36 (SF-36) Health Survey Score
timeFrame: Baseline, End of Follow Up (Up to 18 months)
measure: Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score
timeFrame: Baseline, End of Follow Up (Up to 18 months)
measure: Change in Lent Soma Scale Patient Questionnaire Score
timeFrame: Baseline, End of Follow Up (Up to 18 months)
measure: Change in Breast Pain Level
timeFrame: Baseline, End of Follow Up (Up to 18 months)
measure: Change in Breast Appearance Satisfaction Score
timeFrame: Baseline, End of Follow Up (Up to 18 months)
measure: Change in Radiated Breast Appearance Score
timeFrame: Baseline, End of Follow Up (Up to 18 months)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Mylin Torres, MD
role: PRINCIPAL_INVESTIGATOR
References: