Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer

Phase 1

Withdrawn

• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Chemotherapy-Induced Peripheral Neuropathy; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8
• Interventions: Drug: Lorcaserin; Drug: Lorcaserin Hydrochloride; Other: Questionnaire Administration

• Registration Number: NCT04205071
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate preliminary efficacy of lorcaserin to improve balance decrements in patients with chronic chemotherapy-induced peripheral neuropathy (CIPN).

SECONDARY OBJECTIVES:

I. To evaluate patient reported outcomes (PROs) after a one time dose of lorcaserin in patients with chronic CIPN.

OUTLINE:

Patients receive lorcaserin orally (PO) on day 1.

After completion of study treatment, patients are followed for 4 weeks.

Study Timeline

• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Study Start: 2020-11-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (lorcaserin)	Lorcaserin	Patients receive lorcaserin PO on day 1. The starting dose of lorcaserin will be 10 mg.
Treatment (lorcaserin)	Lorcaserin Hydrochloride	Patients receive lorcaserin PO on day 1. The starting dose of lorcaserin will be 10 mg.
Treatment (lorcaserin)	Questionnaire Administration	Patients receive lorcaserin PO on day 1. The starting dose of lorcaserin will be 10 mg.

Primary Outcome Measures

Name	Time	Method
Measure the improvement in balance for patients with chronic CIPN	Up to 4 weeks	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 Outcome Measures

Name	Time	Method
Improvement in patient-reported chemotherapy-induced peripheral neuropathy symptoms	Baseline up to 4 weeks	Evaluate using Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is an additional PRO. It is a validated instrument that has been used to evaluate pain symptoms and functional capacity in our target population.45