Chemotherapy-induced Peripheral Neuropathy
Conditions
Interventions
control group:Tianchan Capsules placebo orally administered 3 capsules per dose 3 times daily. And FOLFOX or XELOX or SOX chemotherapy regimens.
treatment group:Tianchan Capsules orally administered 3 capsules per dose 3 times daily. And FOLFOX or XELOX or SOX chemotherapy regimens.
Sponsors
Jiangsu Cancer Hospital (Jiangsu Institute of Cancer Research)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age =18 years and =75 years with an expected survival period =3 months; no gender restrictions. 2.Diagnosed with esophageal cancer gastric cancer or colorectal cancer requiring continuation of oxaliplatin-based chemotherapy for =3 cycles. 3.After one or more cycles of oxaliplatin-based chemotherapy the patient has been rated as Grade 2 or higher according to the NCI-CTCAE neurotoxicity criteria and diagnosed with oxaliplatin-induced peripheral neuropathy by an oncologist or neurologist. 4.The patient has undergone radical surgical resection within 12 weeks prior to enrollment. 5.Postoperative carcinoembryonic antigen (CEA) level =1.5× the upper limit of normal (ULN; for current smokers CEA =2.0×ULN is allowed). 6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 7.Adequate organ function: ?Hemoglobin =100 g/L absolute neutrophil count (ANC) =1.5×10?/L platelets =100×10?/L. ?Creatinine clearance >50 mL/min. ?Total bilirubin =1.5×ULN (except in cases of known Gilbert syndrome). ?Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3×ULN (if liver metastases are present AST/ALT =5×ULN). 8.Willing and able to complete examinations and study questionnaires at each data collection point. 9.Mentally clear without psychiatric disorders or cognitive impairment capable of understanding and completing questionnaires and voluntarily signs the informed consent form for participation in this clinical trial.
Exclusion criteria
Exclusion criteria: 1.Presence of neuropathy due to any cause or a family history of neuropathy. 2.Neurodegenerative diseases (e.g. Parkinsons disease Alzheimers disease Huntingtons disease) or neuromuscular disorders (e.g. multiple sclerosis amyotrophic lateral sclerosis poliomyelitis hereditary neuromuscular diseases). 3.Other severe systemic diseases immunoregulatory disorders metabolic diseases (e.g. diabetes hyperthyroidism or hypothyroidism) or severe systemic infectious diseases (e.g. viral or bacterial infections). 4.History of other malignancies within 3 years prior to enrollment except for malignancies cured by local therapy (e.g. basal or squamous cell skin cancer superficial bladder cancer cervical or breast carcinoma in situ). 5.Presence of unhealed surgical wounds. 6.Dihydropyrimidine dehydrogenase (DPD) deficiency. 7.Severe psychiatric disorders (e.g. major depressive disorder psychosis) alcoholism and/or substance abuse. 8.Known hypersensitivity to any component of the investigational product. 9.Women who are pregnant breastfeeding planning pregnancy within 6 months or unwilling to use reliable non-pharmacological contraception from signing the informed consent until the end of follow-up. 10.Participation in another clinical trial within the past month. 11.Use of other interventions for oxaliplatin-induced peripheral neuropathy within 2 weeks prior to the first dose. 12.Any other condition deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (EORTC QLQ-CIPN20) score at the end of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in NCI-CTCAE neurotoxicity grading at the end of treatmen;Change from baseline in the Neuropathic Pain Symptom Inventory (NPSI) score at the end of treatment;Proportion of patients assessed as Grade 1–4 peripheral neurotoxicity and changes in severity according to the oxaliplatin-specific Levi sensory neurotoxicity grading scale at the end of treatment;Cumulative dose of oxaliplatin at the end of follow-up;Objective response rate (ORR) progression-free survival (PFS) and overall survival (OS) of patients.; | — |
Countries
China
Contacts
Public ContactChen Yan
Jiangsu Cancer Hospital (Jiangsu Institute of Cancer Research)
Outcome results
None listed