Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn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Status Withdrawn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
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05528263 - Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial) N/A
Completed NCT03272919 - Chemotherapy Induced Peripheral Neuropathy (CIPN) N/A
Not yet recruiting NCT06430814 - Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
Not yet recruiting NCT05840562 - Capsaicin 179 mg Patch Versus Oral Duloxetine in Patients With Chemotherapy-induced Peripheral Neuropathy Phase 3
Completed NCT02553863 - The Effectiveness and Cost-effectiveness of Acupuncture in Managing Chemotherapy-induced Peripheral Neuropathy N/A
Recruiting NCT04786977 - Physiologic Measure of VIPN
Completed NCT03655587 - Impact of an Orthotic Intervention in Children With Peripheral Neuropathy N/A
Completed NCT03687970 - A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN) N/A
Terminated NCT04770402 - Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients N/A
Completed NCT03254394 - Lidocaine for Oxaliplatin-induced Neuropathy Phase 1/Phase 2
Completed NCT04367480 - Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy N/A
Recruiting NCT04237194 - A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy
Completed NCT04843410 - Effect of Exercise in the Management of Peripheral Neuropathy N/A
Terminated NCT03782402 - Cannabinoids for Taxane Induced Peripheral Neuropathy Phase 2
Not yet recruiting NCT06389721 - Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
Recruiting NCT05121558 - The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy) Phase 3
Withdrawn NCT04492436 - A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo Phase 2
Not yet recruiting NCT03112057 - Visualize Nociceptor Changes in Neuropathic Human N/A
Completed NCT04262778 - Diagnostic of Chemotherapy Induced Neuropathy in Children
Recruiting NCT06324344 - Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN) N/A

External Links