Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial

University of California Irvine (UCI)

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer; Sarcoma; Gastric Cancer; Gynecologic Cancer; Genitourinary Cancer; Lung Cancer; Ovarian Cancer; Head and Neck Cancer; Liver Cancer; Colorectal Cancer

Treatments: Drug: Riluzole; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06580002

UCI 24-05 (Other Identifier)

4994

Details and patient eligibility

About

This is a phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining the impact of riluzole therapy on circulating brain derived neuropathic factor (BDNF) levels of cancer survivors with cancer related cognitive impairment.

Enrollment: 51 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and male patients diagnosed with one of the following:

  1. Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions
  2. Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years
  3. Non-breast cancer patients exposed to other anticancer therapies within the past 3 years

• Washout from investigational interventions is up to the discretion of the Investigator. Concurrent participation in another intervention is allowable if judged by the Principal Investigator that this would not be scientifically or medically incompatible with this study.

• ≥18 years of age

• Perceived by patient or investigator that cognitive function has worsened since cancer diagnosis and/or beginning of cancer treatment

• Able to provide informed consent.

• Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires.

• Patients must agree to complete and be able to complete the questionnaires and computerized assessments used to measure functional outcomes.

Note: Patients who have visual impairment or have degenerative conditions (e.g. Parkinsons's disease, etc.) can participate if they cannot complete computerized assessments, as long as they can still complete the questionnaires with assistance.

Exclusion criteria

• Presence of brain metastasis

• Unwilling to undergo neuropsychological assessments necessary for the study.

• Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy.

  a. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.

• History of suspected hypersensitivity to riluzole or to any of its excipients.

• Patients taking or planned to take medications/substances with potential drug-drug interactions: pixantrone, current smoker (defined as having smoked within the last month), abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole.

• Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN)

• Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

51 participants in 2 patient groups, including a placebo group

Riluzole

Experimental group

Description:

Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for 8 weeks

Treatment:

Drug: Riluzole

Placebo

Placebo Comparator group

Description:

Study participants randomized to this arm will take a placebo, that matches the appearance of 50 mg capsule of riluzole, twice daily (every 12 hours) for 8 weeks

Treatment:

Drug: Placebo