Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ohio State University Comprehensive Cancer Center
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer
