Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hypofractionated Radiotherapy in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03167359
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Mylin Torres, MD, Emory University

Tracking Information
First Submitted Date  ICMJE May 24, 2017
First Posted Date  ICMJE May 30, 2017
Last Update Posted Date July 3, 2018
Study Start Date  ICMJE December 2010
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • Cutaneous Toxicity Rate [ 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.
  • Arm Lymphedema Rate [ Time Frame: Duration of Study (Up to 18 months) ]
    The rate of 20% or greater increase in arm lymphedema (compared to baseline arm measurements) will be assessed among breast cancer patients receiving regional nodal irradiation.
  • Grade 3 Brachial Plexopathy Rate [ Time Frame: Duration of Study (Up to 18 months) ]
    The rate of Grade 3 brachial plexopathy will be assessed among breast cancer patients receiving regional nodal irradiation by RTOG and LENT/SOMA scales
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03167359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2017)
  • Cutaneous Toxicity Rate assessed by Ultrasound Tissue Characterizations (UTC) [ Time Frame: Duration of Study (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.
  • Tumor Necrosis Factor (TNF) - Alpha Levels [ Time Frame: 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.
  • Soluble TNF Receptor 2 (sTNFR2) Levels [ Time Frame: 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.
  • Interleukin (IL)-6 Levels [ Time Frame: Baseline, Post Intervention (Up to 18 Months) ]
    Blood will be analyzed for interleukin (IL)-6 levels and correlated to the development of cutaneous toxicity.
  • Interleukin 1 Receptor Agonist (IL-1ra) Levels [ Time Frame: Baseline, Post Intervention (Up to 18 Months) ]
    Blood will be analyzed for IL-1ra levels and correlated to the development of cutaneous toxicity.
  • C - reactive protein (CRP) Levels [ Time Frame: Baseline, Post Intervention (Up to 18 Months) ]
    Blood will be analyzed for CRP levels and correlated to the development of cutaneous toxicity.
  • Change in Multidimensional Fatigue Inventory (MFI) Score [ Time Frame: 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.
  • Change in Pittsburgh Sleep Quality Index (PSQI) Score [ Time Frame: 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.
  • Change in Perceived Stress Scale (PSS) Score [ Time Frame: 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.
  • Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score [ Time Frame: 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 an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) score [ Time Frame: 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 Short Form-36 (SF-36) Health Survey Score [ Time Frame: 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 [ Time Frame: 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. A score of 24 or more indicates active and substantial exercise benefits. A score of 23 units or less indicates insufficiently active and less substantial exercise benefits.
  • Change in Lent Soma Scale Patient Questionnaire Score [ Time Frame: 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.
  • Change in Breast Pain Level [ Time Frame: 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.
  • Change in Breast Appearance Satisfaction Score [ Time Frame: 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.
  • Difference in Radiated Breast Appearance Score [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypofractionated Radiotherapy in Breast Cancer
Official Title  ICMJE A Pilot Study of Hypofractionated Simultaneous Integrated Boost Radiotherapy in Stage 0, I and III Breast Cancer Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer, Breast
  • Inflammation
Intervention  ICMJE Radiation: 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.
Study Arms  ICMJE Experimental: 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.
Intervention: Radiation: Hypofractionated Simultaneous Integrated Boost Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2017)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mylin Torres, MD 404-778-3473 matorre@emory.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03167359
Other Study ID Numbers  ICMJE IRB00047240
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mylin Torres, MD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mylin Torres, MD Emory University
PRS Account Emory University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP