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
- Intact breast (not surgically absent)
- Ability to give Informed Consent
- Diagnosis of breast cancer
- ...
- Intact breast (not surgically absent)
- Ability to give Informed Consent
- Diagnosis of breast cancer
- Ability to understand and comply with the requirements of this study
- 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)
- For sexually active females, patient agrees to use acceptable method of birth control
- Female, age 18 or older
Exclusion Criteria
- Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
- Planned relocation which would make follow-up visits impossible during the course of the study
- 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
- Planned relocation which would make follow-up visits impossible during the course of the study
- Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
- Severe renal failure creatinine > 3.0 within 6 months of study registration
- Women who are pregnant or lactating
- Collagen vascular disease such as Lupus, or scleroderma
- Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
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
- Intact breast (not surgically absent)
- Ability to give Informed Consent
- Diagnosis of breast cancer
- ...
- Intact breast (not surgically absent)
- Ability to give Informed Consent
- Diagnosis of breast cancer
- Ability to understand and comply with the requirements of this study
- 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)
- For sexually active females, patient agrees to use acceptable method of birth control
- Female, age 18 or older
Exclusion Criteria
- Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
- Planned relocation which would make follow-up visits impossible during the course of the study
- 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
- Planned relocation which would make follow-up visits impossible during the course of the study
- Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
- Severe renal failure creatinine > 3.0 within 6 months of study registration
- Women who are pregnant or lactating
- Collagen vascular disease such as Lupus, or scleroderma
- Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
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