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Hypofractionated Radiotherapy in Breast Cancer

Not Applicable
Completed
Conditions
Inflammation
Cancer, Breast
Interventions
Radiation: Hypofractionated Simultaneous Integrated Boost Radiotherapy
Registration Number
NCT03167359
Lead Sponsor
Emory University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
74
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
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Exclusion Criteria
  • Males will be excluded
  • Women who are pregnant or nursing a child may not take part in this study
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Participants with Stage 0-III breast cancerHypofractionated 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.
Primary Outcome Measures
NameTimeMethod
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 BaselineDuration 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 PlexopathyDuration 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 Outcome Measures
NameTimeMethod
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.

Change in Perceived Stress Scale (PSS) ScoreBaseline, 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 an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) ScoreBaseline, 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 Interleukin 1 Receptor Agonist (IL-1ra) LevelsBaseline, Post Intervention (Up to 18 Months)

Blood will be analyzed for IL-1ra levels and correlated to the development of cutaneous toxicity.

Change in C - Reactive Protein (CRP) LevelsBaseline, Post Intervention (Up to 18 Months)

Blood will be analyzed for CRP levels and correlated to the development of cutaneous toxicity.

Change in Pittsburgh Sleep Quality Index (PSQI) ScoreBaseline, 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 Breast Appearance Satisfaction ScoreBaseline, 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 Soluble TNF Receptor 2 (sTNFR2) LevelsBaseline, 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 LevelsBaseline, 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) ScoreBaseline, 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 Breast Pain LevelBaseline, 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 Tumor Necrosis Factor (TNF) - Alpha LevelsBaseline, 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 Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form ScoreBaseline, 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 Short Form-36 (SF-36) Health Survey ScoreBaseline, 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) ScoreBaseline, 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 ScoreBaseline, 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 Radiated Breast Appearance ScoreBaseline, 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.

Trial Locations

Locations (1)

Emory University

🇺🇸

Atlanta, Georgia, United States

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