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

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ClinicalTrials.gov Identifier: NCT01878695
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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


Condition or disease Intervention/treatment Phase
Stage 0/1 Breast Cancer Post Biopsy Pre-surgery Drug: IV/oral n-acetylcysteine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer
Actual Study Start Date : July 26, 2012
Actual Primary Completion Date : May 14, 2015
Actual Study Completion Date : May 14, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IV and oral n-acetylcysteine

50-150mg/kg of n-acetylcysteine intravenously once a week for at least two weeks.

600mg n-acetylcysteine orally twice daily except on day of infusion

Drug: IV/oral n-acetylcysteine



Primary Outcome Measures :
  1. Efficacy [ Time Frame: 2-4 weeks ]
    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.


Secondary Outcome Measures :
  1. Safety [ Time Frame: 2-4 weeks ]
    To confirm the safety of combined oral and IV NAC in patients with breast cancer. This will be evaluated by the number of participants with adeverse events and Grade 3/4 toxicities according to CTCAE v3.0

  2. 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 [ Time Frame: 2-4 weeks ]
    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

  3. To evaluate potential effects of NAC on quality of life and fatigue [ Time Frame: 2-4 weeks ]
    To evaluate potential effects of NAC on quality of life and fatigue using the FACT-G, Brief Fatigue Inventory, and PROMIS quality assessment instruments.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878695


Locations
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United States, Pennsylvania
Jefferson Myrna Brind Center for Integrative Medicine
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Daniel Monti, MD, MBA Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01878695     History of Changes
Other Study ID Numbers: 12D.396
First Posted: June 17, 2013    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
Integrative Medicine
Breast Cancer
Stage 0
Stage 1

Additional relevant MeSH terms:
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Acetylcysteine
N-monoacetylcystine
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antioxidants
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes