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Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer

Phase 1
18 Years
Open (Enrolling)
Stage 0/1 Breast Cancer, Post Biopsy, Pre-surgery

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Trial Information

Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer

Inclusion Criteria:

- Demographic • Females ≥18 years of age

Disease related

- Stage 0/I breast cancer by biopsy (patients may be consented and screened with
suspected breast cancer, but no treatment will occur until cancer is confirmed by
their biopsy).

- Awaiting surgery which will consist of either lumpectomy or mastectomy.

- ECOG performance status 0-1


- Laboratory values that would not prevent the patient from receiving treatment as
determined by the PI or study oncologist

- Serum creatinine ≤2.0 mg/dL

- Serum bilirubin ≤2.0 X ULN

- Serum HgB ≥8.0 mg/dL


- Competent to comprehend, sign, and date an IRB-approved informed consent form

- Female subjects of childbearing potential have a negative pregnancy test

Exclusion Criteria:

- Disease Related

- History or known presence of metastases

- History of another primary cancer, except:

- Curatively treated cervical carcinoma in situ, or

- Curatively resected non-melanomatous skin cancer, or

- Other primary solid tumor curatively treated with no known active disease present and
no treatment administered for ≤ 3 years prior to enrollment

- Other concurrent anticancer chemotherapy within 4 weeks as determined by the PI

- Any co-morbid disease that would increase risk of toxicity as determined by PI


- Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate,
cyclosporine, corticosteroids)

- Recent infection requiring a course of systemic anti-infectives that was completed ≤
14 days prior to enrollment (exception can be made at the judgment of the PI for oral
treatment of an uncomplicated urinary tract infection ([UTI])


- History of any medical or psychiatric condition or addictive disorder, or laboratory
abnormality that, in the opinion of the PI, may increase the risks associated with
study participation or study drug administration or may interfere with the conduct of
the study or interpretation of study requirements

- History of bronchospasm or severe asthma as determined by the PI

- Subject unwilling or unable to comply with study requirements

- Known positive test(s) for human immunodeficiency virus infection, hepatitis C
virus, chronic active hepatitis B infection

- Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

To assess the feasibility of evaluating the effect of n-acetylcysteine on tumor cell metabolism by assessing the changes in expression of caveolin -1 and MCT4 in cancer associated fibroblasts in pre and post therapy breast tissue treated with NAC.

Outcome Time Frame:

2-4 weeks

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

July 2012

Completion Date:

Related Keywords:

  • Stage 0/1 Breast Cancer
  • Post Biopsy
  • Pre-surgery
  • Integrative Medicine
  • Breast Cancer
  • Stage 0
  • Stage 1
  • Breast Neoplasms



Jefferson Myrna Brind Center for Integrative Medicine Philadelphia, Pennsylvania  19107