Gastric cancer and colorectal cancer
Conditions
Interventions
Highland/Plain Acupuncture Group:Acupuncture will be administered in combination with oxaliplatin-based chemotherapy and standard of care treatment, with each treatment cycle lasting 21 days: On Day 1
treatment will be discontinued upon loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue treatment, or death.
Highland/Plain Control Group:Patients will receive oxaliplatin-based chemotherapy and standard of care treatment, with each treatment cycle lasting 21 days: On Day 1 of each cycle, patients will recei
treatment will be discontinued upon loss of clinical benefit, unacceptable toxicity, patient or physician decision to discontinue treatment, or death.
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Meet the diagnostic criteria; participants recruited by the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine must have resided long-term in a plain area (=10 years, =10 months per year), while those recruited by Qinghai Provincial Hospital of Traditional Chinese Medicine must have resided long-term in a high-altitude area (=10 years, =10 months per year); 2) Have received chemotherapy regimens containing oxaliplatin, with =2 cycles of such treatment, and have no history of chemotherapy regimens containing other platinum-based agents; 3) Have developed Grade 2 peripheral neuropathy prior to enrollment, with peripheral neuropathy caused by other primary or secondary factors excluded; 4) Be between 18 and 75 years of age; gender is not restricted; 5) Have a projected survival period of =6 months; 6) Have an ECOG performance status of =2; 7) Have stable vital signs prior to enrollment, with no significant abnormalities in blood cell analysis, liver and kidney function tests, 12-lead electrocardiogram, and other relevant examinations; 8) Be expected to demonstrate good compliance and be able to cooperate in completing data collection and hematological testing; 9) Have adequate organ and bone marrow function, defined as follows: neutrophils =1,500/µL, hemoglobin =8.0 g/dL, platelets =80,000/µL, serum creatinine < 2.0 mg/dL, bilirubin < 1.5 mg/dL, and alanine aminotransferase (ALT) < 3 times the upper limit of normal (ULN). If obstructive jaundice is present, enrollment is permitted after treatment to resolve jaundice, with liver function criteria appropriately relaxed to bilirubin < 2.5 mg/dL and ALT < 5 times the ULN; 10) Voluntarily participate in this study, demonstrate good compliance, and be willing to sign the informed consent form for this study.
Exclusion criteria
Exclusion criteria: 1) ECOG performance status > 3; (2) Expected survival < 6 months; (3) Other serious diseases or conditions, including deep vein thrombosis of the lower extremities, congestive heart failure (New York Heart Association Class III or IV), unstable angina, etc.; 4) History of prior chemotherapy regimens containing other platinum-based agents; (5) History of use within 1 month prior to enrollment of other medications that may prevent or treat oxaliplatin-related neurotoxicity; (6) Primary or secondary neurological disorders caused by other factors (e.g., medications, diseases, etc.); (7) Patients with a history of allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade of oxaliplatin-induced peripheral neuropathy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease control rate;Peripheral blood tests related to tolerability and safety: complete blood count, liver and kidney function tests, electrolyte levels, and coagulation tests.;Incidence of adverse reactions;Peripheral blood immune-related markers;Peripheral Blood Immune Balance Markers;Quality of life indicators; | — |
Countries
China
Contacts
Public ContactWentao Li
Department of Oncology,First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed