Lorcaserin in Treating Chemotherapy-Induced Peripheral Ne... | NCT04205071

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

NCT04205071

Sponsor

Ohio State University Comprehensive Cancer Center

Status

Withdrawn

Last Update Posted

Jan 19, 2021Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

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
Chemotherapy-Induced Peripheral Neuropathy
Digestive System Carcinoma
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

Interventions

Lorcaserin
Lorcaserin Hydrochloride
Questionnaire Administration

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2019-03368	Registry Identifier	CTRP (Clinical Trial Reporting Program)
P30CA016058	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI decision

Expanded Access Info

Start Date

Nov 1, 2020Estimated

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Aug 5, 2019

First Submission Date that Met QC Criteria

Dec 17, 2019

First Posted Date

Dec 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2021

Last Update Posted Date

Jan 19, 2021Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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
Chemotherapy-Induced Peripheral Neuropathy
Digestive System Carcinoma
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

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment (lorcaserin)	Experimental	Patients receive lorcaserin PO on day 1. The starting dose of lorcaserin will be 10 mg.	Drug: Lorcaserin Drug: Lorcaserin Hydrochloride Other: Questionnaire Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lorcaserin	Drug	Given PO	Treatment (lorcaserin)
Lorcaserin Hydrochloride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided