HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 30
Inclusion Criteria
- Ability to give Informed Consent
- Female, age 18 or older
- Diagnosis of breast cancer
- ...
- Ability to give Informed Consent
- Female, age 18 or older
- Diagnosis of breast cancer
- For sexually active females, patient agrees to use acceptable method of birth control
- Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions)
- Ability to understand and comply with the requirements of this study
- Intact breast (not surgically absent)
Exclusion Criteria
- Severe renal failure creatinine > 3.0 within 6 months of study registration
- Women who are pregnant or lactating
- Planned relocation which would make follow-up visits impossible during the course of the study
- ...
- Severe renal failure creatinine > 3.0 within 6 months of study registration
- Women who are pregnant or lactating
- Planned relocation which would make follow-up visits impossible during the course of the study
- Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
- Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
- Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
- Collagen vascular disease such as Lupus, or scleroderma
Summary
- Conditions
- Breast Cancer
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Only females
Description
Patients will be allocated to the treatment using a randomized permuted block. There will be no stratification. Patients will be randomized to receive the investigational product to be applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo product will be used on...
Patients will be allocated to the treatment using a randomized permuted block. There will be no stratification. Patients will be randomized to receive the investigational product to be applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo product will be used on the other side. Patients and clinical investigators will be blinded to the treatment assignments.
Inclusion Criteria
- Ability to give Informed Consent
- Female, age 18 or older
- Diagnosis of breast cancer
- ...
- Ability to give Informed Consent
- Female, age 18 or older
- Diagnosis of breast cancer
- For sexually active females, patient agrees to use acceptable method of birth control
- Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions)
- Ability to understand and comply with the requirements of this study
- Intact breast (not surgically absent)
Exclusion Criteria
- Severe renal failure creatinine > 3.0 within 6 months of study registration
- Women who are pregnant or lactating
- Planned relocation which would make follow-up visits impossible during the course of the study
- ...
- Severe renal failure creatinine > 3.0 within 6 months of study registration
- Women who are pregnant or lactating
- Planned relocation which would make follow-up visits impossible during the course of the study
- Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
- Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
- Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
- Collagen vascular disease such as Lupus, or scleroderma
Tracking Information
- NCT #
- NCT02165605
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Asal Rahimi, MD University of Texas Southwestern Medical Center
- Asal Rahimi, MD University of Texas Southwestern Medical Center