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Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy (SPiRiT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04567251
Recruitment Status : Not yet recruiting
First Posted : September 28, 2020
Last Update Posted : July 23, 2021
Sponsor:
Collaborators:
Allergan
Varian Medical Systems
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE September 23, 2020
First Posted Date  ICMJE September 28, 2020
Last Update Posted Date July 23, 2021
Estimated Study Start Date  ICMJE August 2021
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2020)
  • Effect of Namzaric® on cognition among cancer survivors who received brain irradiation [ Time Frame: Baseline, 15 weeks ]
    Mean change between baseline and 15 weeks in the Brief Cognitive Assessment (BAC) composite cognitive score within each treatment group
  • Feasibility of using a digital symptom tracking application on HRQoL and cognition in cancer survivors who received brain irradiation [ Time Frame: Baseline, 15 weeks ]
    A percentage of patients returning for their 15 week clinic appointment who initiate a PROMIS questionnaire via the mobile application at weeks 9 and 14
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy
Official Title  ICMJE Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy: Focus on Health-Related Quality of Life and Cognition
Brief Summary The primary objectives of this randomized, placebo-controlled, double-blind study are to 1) assess whether or not Namzaric® improves cognitive function in cancer survivors who received prior brain irradiation as part of their standard of care therapy and 2) assess the feasibility of using a digital symptom tracking application focused on Health Related Quality of Life (HRQoL) and cognition in cancer survivors who received brain irradiation. Exploratory objectives include assessing longitudinally the effect of Namzaric® on Patient Reported Outcomes (PROs) as reported in the clinic, including measures of health-related quality of life, cognition, and financial toxicity and evaluating the safety and tolerability of administering Namzaric® to cancer survivors who have received prior irradiation.
Detailed Description Patients who may participate in the study are cancer survivors who received cranial irradiation for conditions including, but not limited to: primary brain tumors, brain metastases, patients with lung cancer receiving prophylactic brain irradiation, and long-term survivors of pediatric cancers. Up to 102 patients will be randomized 1:1 so half the patients receive Namzaric® and half receive placebo. Patients on both arms will be taking Namzaric® or placebo for 17 weeks, including dose-escalation and tapering. Patients will use a symptom monitoring app, Noona® Healthcare Mobile PRO Application, to identify real-time select HRQoL and cognitive symptoms during Namzaric® vs placebo therapy. Patients will be instructed to log symptoms as often as relevant using their own personal devices, as well as be prompted to fill out the Patient-Reported Outcomes Measurement Information System Global Health Screen (PROMIS Global Health-10) during treatment (weeks 9 and 14). There will be no patient follow-up after completing or discontinuing the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Metastases, Adult
  • Primary Brain Tumor
  • Lung Cancer
Intervention  ICMJE
  • Drug: Namzaric®

    Namzaric® will be given for 17 weeks using the following dosing schedule:

    7 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week, 14 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week, 21 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week, 28 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 12 weeks, 14 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week, 7 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week.

  • Drug: Placebo
    Placebo drug, which will look identical to commercial Namzaric®, will be given for 17 weeks including a 3 week dose-escalation, 12 week maintenance period, and 2 week taper.
Study Arms  ICMJE
  • Experimental: Namzaric® arm
    Arm 1 will take daily Namzaric® for 17 weeks, including 3 weeks of dose-escalation, 12 weeks at a stable dose, and a 2 week taper.
    Intervention: Drug: Namzaric®
  • Placebo Comparator: Placebo arm
    Arm 2 will take daily placebo for 17 weeks, including 3 weeks of dose-escalation, 12 weeks at a stable dose, and a 2 week taper.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2020)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Cancer survivors who received cranial irradiation including, but not limited to, primary brain tumor, brain metastases, lung cancer receiving prophylactic brain irradiation, long-term survivors of pediatric cancers
  2. Completed a course of fractionated partial brain irradiation or whole brain irradiation of at least 30 (Gray) Gy more than 6 months prior to enrollment
  3. Age ≥ 18 years at the time of entry into the study
  4. Karnofsky performance score (KPS) ≥ 70 or Eastern Cooperative Oncology Group (ECOG) grade ≤ 2.
  5. No imaging evidence of disease progression within 4 months of enrollment
  6. Life expectancy > 6 months
  7. Access to a smartphone, tablet, or computer with capability to utilize the mobile symptom-tracking application

Exclusion Criteria:

  1. Active psychiatric illness
  2. Clinically significant renal disease or insufficiency at the time of screening
  3. History of severe liver disease or laboratory values for liver function tests > 2.5 times the upper limit of normal at screening
  4. Use of cognition-enhancing medications at the time of screening. If patients have used cognition-enhancing medications in the past, a wash-out period can be considered for screening of 8 weeks at the discretion of the PI.
  5. Allergy to Namzaric or any of the components of Namzaric.
  6. Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katherine Peters, MD, PhD 919-684-5301 dukebrain1@duke.edu
Contact: Sarah Woodring 919-684-5301 dukebrain1@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04567251
Other Study ID Numbers  ICMJE Pro00102684
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Allergan
  • Varian Medical Systems
Investigators  ICMJE
Principal Investigator: Katherine Peters, MD, PhD Duke University
PRS Account Duke University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP