RECRUITING

Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel (Phase II)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial tests the safety, side effects, and best dose of monosialotetrahexosylganglioside (GM1) and whether it works in reducing or preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving treatment with paclitaxel. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Exposure to chemotherapy drugs like paclitaxel may cause a side effect called CIPN, which is a condition of weakness, numbness, and pain from nerve damage (usually in the hands and feet). GM1 is a part of the body's natural system that insulates nerves and helps to protect nerves from damage. Giving GM1 may help reduce or prevent CIPN in breast cancer patients receiving treatment with paclitaxel.

Official Title

An Early Phase and Phase II Clinical Trial to Evaluate Ganglioside-Monosialic Acid (GM1) for Preventing Paclitaxel-Associated Neuropathy

Quick Facts

Study Start:2023-11-02
Study Completion:2030-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05751668

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documentation of disease: Histologic diagnosis of metastatic breast cancer in women or men
  2. * Prior treatment- No previous exposure to GM1
  3. * Planned administration of paclitaxel, either given weekly, or weekly 3 weeks on/1 week off, to patients with metastatic cancer at a dose of 80 mg/m\^2
  4. * No planned treatment with concurrent immunotherapy
  5. * Score of 1 (none) and/or 2 (a little) on the six individual European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ)- chemotherapy-induced peripheral neuropathy (CIPN)20 questions that quantify numbness (N), tingling (T), and pain in the fingers/hands and toes/feet (Items #31-36)
  6. * No diagnosis of fibromyalgia
  7. * No history of significant respiratory tract infection and/or infectious diarrhea within 14 days before registration
  8. * No history of stroke or cerebrovascular accident in the past 6 months prior to registration
  9. * No history of diagnosed neurologic or psychiatric disorders, including epilepsy or dementia
  10. * For women of childbearing potential, not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
  11. * Ability to complete questionnaires by themselves or with assistance
  12. * In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English and/or Spanish
  13. * Persons with impaired decision making such that they cannot understand the benefits or risks of trial participation, per the judgement of the consenting clinician, will not be eligible
  14. * Age \>= 18 years
  15. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  16. * Absolute neutrophil count (ANC) \>= 1,000/mm\^3
  17. * Platelet count \>= 100,000/mm\^3
  18. * Creatinine =\< 1.5 x upper limit of normal (ULN)
  19. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
  20. * Total bilirubin =\< 1.5 x ULN
  21. * No planned use of duloxetine
  22. * No planned use of cryotherapy, compression therapy, or cryocompression therapy at study entry
  1. * N/A

Contacts and Locations

Study Contact

Elizabeth Cathcart-Rake, MD
CONTACT
507-768-4411
Cathcart-Rake.Elizabeth@mayo.edu
Aishwarya Vijendran
CONTACT
773-834-9613
aishwaryav@bsd.uchicago.edu

Study Locations (Sites)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Morton Plant Hospital
Clearwater, Florida, 33756
United States
Saint Anthony's Hospital Cancer Care Center
Saint Petersburg, Florida, 33705
United States
Mission Cancer and Blood - Ankeny
Ankeny, Iowa, 50023
United States
Mercy Hospital
Cedar Rapids, Iowa, 52403
United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Mission Cancer and Blood - Des Moines
Des Moines, Iowa, 50309
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017
United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030
United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062
United States
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington, 98684
United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: Alliance for Clinical Trials in Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-02
Study Completion Date2030-05-31

Study Record Updates

Study Start Date2023-11-02
Study Completion Date2030-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Chemotherapy-Induced Peripheral Neuropathy
  • Metastatic Breast Carcinoma