Recruiting

Observational Study

Sponsor:

Disarm Therapeutics

Code:

NCT03997981

Conditions

Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a prospective natural history study of CIPN in approximately 200 participants receiving taxanes (paclitaxel, docetaxel) for breast cancer, bortezomib for multiple myeloma, oxaliplatin-based regimens for colorectal cancer, or vincristine for lymphoma.. Demographic data, medical history, electronic PROs, ClinROs blood biomarkers including NF-L, PGx DNA analyses and Bedside-QST will be assessed at Baseline. The Observation Period will initiate with the first dose of chemotherapy and conclude with the last dose of chemotherapy. During the Observation Period, participants will be evaluated for the development of CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will be measured at various timepoints corresponding with treatment regimen schedules throughout the observation period. The Post Chemotherapy Follow-up Period will begin with the first visit after the last dose of chemotherapy and conclude 6 months after the last dose of chemotherapy. During the Post Chemotherapy Follow-up Period, participants will be evaluated for CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will also be measured at the beginning and at the end of the Post-Chemotherapy Follow-up Period. PROs will be assessed electronically on a monthly basis.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study ID

NCT03997981

Start date

Jul 3, 2019

Status verified date

Feb, 2024

Completion date

Apr 9, 2024

Anticipated

Primary completion date

Mar 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

All of the following criteria must be met in order to be enrolled in the study:

  • Age ≥18 years
  • Life expectancy ≥6 months
  • Participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade 0 CIPN (exception, patients with multiple myeloma treated with bortezomib, CTCAE Grade <=1)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Breast cancer only:

  • Breast cancer beginning treatment with paclitaxel or docetaxel with curative intent (i.e., not metastatic disease beyond regional lymph nodes)
  • Planned minimum of 6 cycles of chemotherapy
  • Lymphoma only:

  • Incident lymphoma initiating treatment with vincristine
  • Planned minimum of 4 cycles of chemotherapy
  • Oxaliplatin-based regimens, Stage III colorectal cancer: Total of 6 months (planned minimum of 12 cycles). May consider Stage IV with minimal metastatic confirmed with Sponsor prior to enrollment
  • Bortezomib use in untreated multiple myeloma: Total of 4 months (planned minimum of 9 cycles)
  • Written informed consent given
  • Enrollment must be completed prior to receiving the first dose of chemotherapy

Exclusion Criteria:

Patients meeting ANY of the following criteria are not eligible for participation:

  • Evidence of central nervous system metastases
  • Evidence of clinically significant peripheral neuropathy (CTCAE >2) as defined by patient report of frequent numbness or tingling in the hands or feet
  • Any uncontrolled serious illness or medical condition that would impact the conduct of the current study
  • Previous exposure to neurotoxic chemotherapy drugs
  • Pre-existing neurodegenerative disease (Parkinson's, Alzheimer's, Huntington's, etc.), neuromuscular disorder (multiple sclerosis, ALS, polio, hereditary neuromuscular disease) or history of stoke or history of traumatic brain injury
  • General anesthesia less than one month prior to the first dose of neurotoxic chemotherapy

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Breast cancer patients with weekly/biweekly paclitaxel regimen

Breast cancer patients receiving docetaxel regimen

Lymphoma patients receiving vincristine regimen

Multiple myeloma patients receiving bortezomib regimen

Colorectal cancer patients receiving oxaliplatin-based regimens

Primary outcome measure

  • Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy [ Time Frame: Through study completion, 2 years ]

Central Contacts and Locations

Central contacts

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559ClinicalTrials.gov@lilly.com

Locations

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201-1544

Contacts

410-706-7250

Principal Investigator:

Susan Dorsey, Ph.D, RN, FAAN

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109-0400

Contacts

734-936-1267

Principal Investigator:

Ellen Smith, PhD, APRN, AOCN, FAAN

University of Pensylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

215-615-3820

Principal Investigator:

Chafic Karam

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

802-847-4589

Principal Investigator:

Noah Kolb, MD

VCU Medical Center

Recruiting

Richmond, Virginia, United States, 23298

Principal Investigator:

Gordon Smith, MD

More Information

Sponsor

Disarm Therapeutics

Last update posted

Mar 1, 2024

Last verified

Feb, 2024

Keywords

  • CIPN

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Disarm Therapeutics on 2024-03-01.