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Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT

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ClinicalTrials.gov Identifier: NCT04520139
Recruitment Status : Not yet recruiting
First Posted : August 20, 2020
Last Update Posted : February 23, 2021
Sponsor:
Collaborator:
Jarrow Formulas Inc
Information provided by (Responsible Party):
Daniela A. Bota, University of California, Irvine

Brief Summary:
This is a phase I, dose-escalation and phase II dose-expansion clinical trial determining the maximum tolerated dose (MTD) and safety and tolerability of adding N-Acetyl-Cysteine (NAC) to ovarian cancer patients who are receiving a platinum-based therapy (PBT). This study will investigate whether NAC will mitigate chemotherapy-related cognitive impairment (CRCI).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Cognitive Impairment Drug: N-Acetyl-Cysteine Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

Phase 1 will be a dose-escalating design.

Phase 2 will be a randomized, double-blinded, placebo-controlled study design

Masking: Double (Participant, Investigator)
Masking Description:

Phase 1 will be open label.

Phase 2 will be be double-blinded.

Primary Purpose: Treatment
Official Title: Phase I Dose-Escalating and Phase II Dose-Expansion Study of N-Acetyl-Cysteine (NAC) Administration to Ovarian Cancer Patients Receiving Platinum-Based Therapy (PBT) for the Mitigation of Chemotherapy-Related Cognitive Impairment (CRCI)
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : April 2025


Arm Intervention/treatment
Experimental: Phase 1 Dose Escalation
Patients will receive NAC beginning at Cohort 1. If, at a given dose, none of the 3 patients shows a dose-limiting toxicity during the first cycle of PBT, then the dose is escalated 1 step for subsequent subjects. If, at a given dose, only 1 of 3 shows a dose-limiting toxicity, then up to 3 additional participants will be enrolled at that dose.If, at a given dose, the first 2, or any 2 of 3 subjects show a dose-limiting toxicity, then the dose will be de-escalated 1 step for future participants. At a dose where enrollment is expanded to between 4 and 6, if only 1 of 6 subjects shows a dose-limiting toxicity, then the dose will be escalated 1 step for future participants. However, if 2 or more of 4, 5, or 6participants show a dose-limiting toxicity, then the dose will be reduced one step for future participants. The maximum tolerated dose is defined as the highest dose not requiring deescalation. This is the dose to be used for the NAC arm of Phase II study.
Drug: N-Acetyl-Cysteine
Given PO
Other Names:
  • NAC Sustain
  • NAC

Experimental: Phase 2 Dose Expansion
Patients will be randomized to receive NAC at the maximum tolerated dose or placebo.
Drug: N-Acetyl-Cysteine
Given PO
Other Names:
  • NAC Sustain
  • NAC

Other: Placebo
Given PO




Primary Outcome Measures :
  1. Maximum Tolerated Dose of N-Acetyl-Cysteine in Ovarian Cancer Patients Receiving Platinum-Based Therapy [ Time Frame: From the start date of treatment until 6 months after removal of treatment due to toxicity, termination of study or withdrawal of treatment, whichever came first. ]
    Determination of the maximum tolerated dose (MTD) will be utilized to evaluate the safety and tolerability of adding N-Acetyl-Cysteine (NAC) in ovarian cancer patients who are also receiving platinum-based therapy (PBT), using a Phase I, dose-escalating design.

  2. Recommended Phase 2 Dose for NAC administered with PBT [ Time Frame: From the start date of treatment until 6 months after removal of treatment due to toxicity, termination of study or withdrawal of treatment, whichever came first. ]
    Determination of the recommended Phase 2 dose (RP2D) will be utilized to evaluate the safety and tolerability of adding NAC to PBT.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study targets post-menopausal women with a histologically confirmed diagnosis of stage III-IV eipithelial ovarian cancer, fallopian tube, or primary peritoneal cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Post-menopausal females (as defined by lack of menstruation for 12 months or status post oophorectomy)

  • Histologic or pathologic diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Eastern Cooperative Oncology Group (ECOG) ≤2
  • Life expectancy > 1 year
  • Status post cytoreductive surgery for ovarian cancer or with planned cytoreductive surgery if treated with neoadjuvant chemotherapy
  • Prescribed a minimum of six cycles of platinum-based chemotherapy
  • Adequate organ function as defined below:

    1. Hemoglobin > 9 g/dL
    2. Leukocytes >1,500/mcl
    3. Absolute Neutrophil Count > 1,000/mcL
    4. Platelets > 125,00/mcL
    5. total bilirubin Within normal institutional limits
    6. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x institutional upper limit of normal
    7. Serum creatinine < 1.5 mg/dL.

Exclusion Criteria:

  • Prior history of any cancer (other than non-melanoma skin cancer)
  • Chemotherapy, radiation therapy, or erythropoietin treatment within the last 6 months
  • Prior severe head injury
  • Has a history of dementia or other neurodegenerative disorders
  • Has an uncontrolled, treatment-resistant depression or other severe psychiatric illnesses
  • Presence of known brain metastases
  • Has an active infection requiring treatment
  • Known immunosuppressive disease
  • Has active systemic autoimmune diseases such as lupus
  • Receipt of systemic immunosuppressive therapy
  • Known human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
  • Pregnant of breastfeeding.

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): NCT04520139


Contacts
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Contact: Chao Family Comprehensive Cancer Center University of California, Irvine 1-877-827-7883 ucstudy@uci.edu
Contact: University of California Irvine Medical

Sponsors and Collaborators
University of California, Irvine
Jarrow Formulas Inc
Investigators
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Principal Investigator: Daniela Bota, MD, PhD Chao Family Comprehensive Cancer Center
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Responsible Party: Daniela A. Bota, Associate Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT04520139    
Other Study ID Numbers: UCI 18-120 [HS# 2020-5846]
2020-5846 ( Other Identifier: University of California, Irvine )
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniela A. Bota, University of California, Irvine:
Chemotherapy-Related Cognitive Impairments
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Cognitive Dysfunction
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes