Clinical trial · Interventional
Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer
Pilot Trial of Acute Effect of Lorcaserin to Reduce Patient-Reported Symptoms of Taxane- and Oxaliplatin-Induced Peripheral Neuropathy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI decision
Summary
Brief summary (as posted)
This phase I trial studies how well lorcaserin works in treating chemotherapy-induced peripheral neuropathy in patients with stage I-IV gastrointestinal or breast cancer. Chemotherapy-induced peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. This condition can occur in patients who have received taxane chemotherapy drugs, or the chemotherapy drug oxaliplatin. Lorcaserin may improve chemotherapy-induced peripheral neuropathy by reducing pain, preventing or relieving joint symptoms, and improving balance.
Conditions
Conditions (24)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIB Breast Cancer AJCC v8 | — | UNRESOLVED |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lorcaserin | Drug | — | UNRESOLVED |
| Lorcaserin Hydrochloride | Drug | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (lorcaserin)
- description
- Patients receive lorcaserin PO on day 1. The starting dose of lorcaserin will be 10 mg.
- interventionNames
- Drug: Lorcaserin
- Drug: Lorcaserin Hydrochloride
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Measure the improvement in balance for patients with chronic CIPN
- timeFrame
- Up to 4 weeks
- description
- Will be evaluated using a measure of postural control: root-mean-squared amplitude of center of pressure (COP) excursion for the medial-lateral axis of the body .
Secondary outcomes (1)
- measure
- Improvement in patient-reported chemotherapy-induced peripheral neuropathy symptoms
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with known diagnosis of gastrointestinal (GI) cancer or breast cancer stages I-IV * Prior exposure to paclitaxel or oxaliplatin within last 24 months * Have symptomatic CIPN confirmed by self-report, as demonstrated by PRO measure, CIPN-20 * If a female subject is with child bearing potential, she must have a negative pregnancy test at screening * Female subjects of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 3 months after completion of study treatment administration. Adequate contraception includes methods such as oral contraceptives, double barrier method (condom plus spermicide or diaphragm), or abstaining from sexual intercourse * Be willing and able to understand and sign the written informed consent document Exclusion Criteria: * Is beyond 24 months out from completion of oxaliplatin or paclitaxel * Is asymptomatic for CIPN * Is currently pregnant or breast feeding as there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lorcaserin * Has any other medical or psychiatric condition that in the opinion of the investigator would make the study therapy unsafe for the patient
References
Publications (0)
Data not yet available