Recruitment

Recruitment Status
Completed
Estimated Enrollment
30

Inclusion Criteria

Female, age 18 or older
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
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
Ability to give Informed Consent
Ability to understand and comply with the requirements of this study
Intact breast (not surgically absent)
Diagnosis of breast cancer

Exclusion Criteria

Collagen vascular disease such as Lupus, or scleroderma
Women who are pregnant or lactating
Planned relocation which would make follow-up visits impossible during the course of the study
...
Collagen vascular disease such as Lupus, or scleroderma
Women who are pregnant or lactating
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
Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
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

Female, age 18 or older
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
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
Ability to give Informed Consent
Ability to understand and comply with the requirements of this study
Intact breast (not surgically absent)
Diagnosis of breast cancer

Exclusion Criteria

Collagen vascular disease such as Lupus, or scleroderma
Women who are pregnant or lactating
Planned relocation which would make follow-up visits impossible during the course of the study
...
Collagen vascular disease such as Lupus, or scleroderma
Women who are pregnant or lactating
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
Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
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