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

Chemotherapy-Induced Peripheral Neuropathy Clinical Trial

Official title:

Pilot Trial of Acute Effect of Lorcaserin to Reduce Patient-Reported Symptoms of Taxane- and Oxaliplatin-Induced Peripheral Neuropathy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04205071
• Other study ID #: OSU-19085
• Secondary ID: NCI-2019-03368P3
• Status: Withdrawn
• Phase: Phase 1
• Start date: November 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage IA Breast Cancer AJCC v8
• Anatomic Stage IB Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage IIA Breast Cancer AJCC v8
• Anatomic Stage IIB Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IIIA Breast Cancer AJCC v8
• Anatomic Stage IIIB Breast Cancer AJCC v8
• Anatomic Stage IIIC Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Breast Neoplasms
• Chemotherapy-Induced Peripheral Neuropathy
• Digestive System Carcinoma
• Peripheral Nervous System Diseases
• Prognostic Stage I Breast Cancer AJCC v8
• Prognostic Stage IA Breast Cancer AJCC v8
• Prognostic Stage IB Breast Cancer AJCC v8
• 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
• Prognostic Stage IIIC Breast Cancer AJCC v8
• Prognostic Stage IV Breast Cancer AJCC v8

Intervention

Drug:
• Lorcaserin
Given PO
• Lorcaserin Hydrochloride
Given PO

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nerve conduction test (NCT) result analysis	The study will compare baseline variables of patients with abnormal NCT results to those with normal NCT results. Will present descriptive statistics and perform t-tests comparing the two groups with respect to demographics (age, BMI), RMSml, and patient-reported outcomes (CIPN 20, BPI-SF).	Baseline up to 4 weeks
Primary	Measure the improvement in balance for patients with chronic CIPN	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 .	Up to 4 weeks
Secondary	Improvement in patient-reported chemotherapy-induced peripheral neuropathy symptoms	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	Baseline up to 4 weeks

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