Oxaliplatin-induced peripheral neuropathy. Drug-induced polyneuropathy
Conditions
Interventions
Intervention 1: Intervention group: Treatment with melatonin will be started on the evening of the first chemotherapy dose and continue through 1 month following the last dose of chemotherapy or 6 mon
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Histologically confirmed stage II-IV colorectal cancers, scheduled to receive oxaliplatin-based chemotherapy (XELOX or FOLFOX with 85 or 130 mg/m2 oxaliplatin every 2 or 3 weeks, respectively =18 years of age Eastern Oncology Group (ECOG) Performance Status 0, 1 or 2 The following laboratory values obtained =30 days prior to registration: • PLT =100,000 • WBC =3000 • HgB =10 • Total bilirubin =1.5 x upper normal limit (UNL) • Serum creatinine =1.5 x UNL • AST, ALT = 2.5 x UNL Negative pregnancy test (serum or urine) done = 7 days prior to registration, for women of childbearing potential only Willingness to take part in the study and ability to complete questionnaire by themselves or with assistance and to do study protocol Provide informed written consent, with the right that patients could stop whenever they want
Exclusion criteria
Exclusion criteria: Pregnancy, lactation or unwilling to employ adequate contraception for women of childbearing potential Prior treatment with neurotoxic chemotherapy such as oxaliplatin, cisplatin, taxanes, or vinca alkaloids Pre-existing peripheral neuropathy (motor or sensory) of any grade A family history of a genetic/familial neuropathy Other medical conditions which, in the opinion of the treating physician, would makes the patient unable to participate in the study (because of safety concerns or noncompliance) Inability to swollow Allergy to oxaliplatin, leucovorin, fluorouracil, capecitabine, melatonin or excipients present in formulation of any of them Concurrent consumption of other medications which are effective in preventing or treating neuropathic pain like carbamazepine, phenytoin, valproic acid, lamotrigin, gabapentin, pregabalin, venlafaxine, duloxetine, tricyclic antidepressants (such as amitryptilline), topical lidocaine, topical capsaicin, supplements like L-Carnitine or vitamin B1 and B6 or any other agent specifically being given to prevent or treat neuropathic pain Diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of grade 2 and 3 neuropathy according to National Cancer Institute’s Common Toxicity Criteria for adverse events (NCI-CTCAE V.4) will be compered among the two study groups (case and control), as the main outcome of the study. Timepoint: Prior to the start of study; during the chemotherapy (prior to receiving each cycle); 1 month after receiving the last dose of chemotherapy or 6 months after initiation of melatonin (each one happens earlier). Method of measurement: National Cancer Institute’s Common Toxicity Criteria for adverse events (NCI-CTCAE V.4) scale will be used by the oncologist to evaluate severity of neuropathy in the patients. According to this scale severity of neuropathy will be classified from 1 to 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients quality of life according to EORTC QLQ-30 questionnaire will be compared among two groups. Timepoint: Prior to the start of study; during the chemotherapy (prior to receiving each cycle); 1 month after receiving the last dose of chemotherapy or 6 months after initiation of melatonin (each one happens earlier). Method of measurement: By the persian version of EORTC QLQ-30 questionnaire.;Severity of neuropathy according to patients' declaration. Timepoint: Prior to the start of study; during the chemotherapy (prior to receiving each cycle); 1 month after receiving the last dose of chemotherapy or 6 months after initiation of melatonin (each one happens earlier). Method of measurement: By chemotherapy-induced peripheral neuropathy questionnaire (EORTC CIPN-20) which will be translated to persian language and will be validated prior to study initiation.;Severity of neuropathy according to oxaliplatin- specific scale which is evaluated by the physician. Timepoint: Prior to the start of study; during the chemotherapy (prior to receiving each cycle); 1 month after receiving the last dose of chemotherapy or 6 months after initiation of melatonin (each one happens earlier). Method of measurement: By oxaliplatin- specific scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRaziyeh Kheshti
Shiraz University of Medical Sciences
Outcome results
None listed