Clinical trial NCT01878695: Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer
Official title: Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stage 0/1 Breast Cancer
Post Biopsy
Pre-surgery
Keywords: Integrative Medicine
Breast Cancer
Stage 0
Stage 1
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: NAC is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement and also is available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. In the exercise physiology literature, both oral and injectable NAC have been shown to reduce fatigue and improve recovery from exertion which has interesting implications for exploring cancer-related fatigue.

In terms of cancer cell biology, reactive oxygen species (ROS) may play an important role in the development and progression of breast cancer


Eligibility criteria: 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

* 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

General

* 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

Medications/Treatments

* 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 (\[UTI\])

General

* 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 enrollment

Primary outcomes:
measure: Efficacy
timeFrame: 2-4 weeks
Secondary outcomes:
measure: Safety
timeFrame: 2-4 weeks
measure: 2. To access the changes in HIF-1 alpha and p65 subunit of NFB in tumor stroma in pre and post therapy breast tissue treated with NAC
timeFrame: 2-4 weeks
measure: To evaluate potential effects of NAC on quality of life and fatigue
timeFrame: 2-4 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Myrna Brind Center for Integrative Medicine
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Daniel Monti, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: