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Randomized, Double-blind, Split-body, Placebo-controlled Phase Ib Study of Lipoxysan (Liposomal Recombinant Human Cu/Zn-Superoxide Dismutase) for the Prevention of Radiation-induced Dermatitis in Patients With Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Radiation Induced Dermatitis

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Trial Information

Randomized, Double-blind, Split-body, Placebo-controlled Phase Ib Study of Lipoxysan (Liposomal Recombinant Human Cu/Zn-Superoxide Dismutase) for the Prevention of Radiation-induced Dermatitis in Patients With Breast Cancer


Inclusion Criteria:



- Women ≥ 18 years of age, with breast cancer, treated by breast conserving surgery and
scheduled to receive adjuvant radiotherapy to the breast alone

- Bra cup size ≤D

- Karnofsky performance status of ≥ 80%

- Women of childbearing potential must have a negative pregnancy test before study
entry and must agree to use a medically acceptable method of birth control throughout
the study period

- Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

- Bilateral breast cancer

- Inflammatory breast cancer

- Lymphangiosis carcinomatosa

- Medically significant dermatologic conditions affecting the irradiated area

- Planned use of other agents with the aim of preventing and/or treating radiation
dermatitis

- Concomitant medications which might exacerbate radiation dermatitis

- History of previous radiation therapy of the breast

- Pregnancy or breastfeeding

- Having received any other investigational agent within 4 weeks before enrolment

- Uncontrolled intercurrent illness including, but not limited to psychiatric
illness/social situations that would limit compliance with study requirements

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

To evaluate safety and tolerability of APN201

Outcome Description:

Adverse events, vital signs and laboratory assessments (hematology, serum chemistry) are used for safety evaluations.

Outcome Time Frame:

From baseline until 1 day following the final radiotherapy fraction, assessed for a maximum of 28 radiotherapy fractions.

Safety Issue:

Yes

Authority:

Austria: Agency for Health and Food Safety

Study ID:

APN201-1-01

NCT ID:

NCT01513278

Start Date:

January 2012

Completion Date:

August 2012

Related Keywords:

  • Radiation Induced Dermatitis
  • Breast Neoplasms
  • Dermatitis
  • Radiodermatitis

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