A randomized controlled trial of acupuncture for oxaliplatin-induced peripheral neuropathy at different altitudes based on immune balance

Authors
Category Primary study
Registry of TrialsInternational Traditional Medicine Clinical Trial Registry
Year 2026
INTERVENTION: 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 of each cycle, participants will receive intravenous infusion of the oxaliplatin‐based chemotherapy regimen and standard of care treatment, along with acupuncture treatment administered every other day, three times per week; 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 receive an intravenous infusion of the oxaliplatin‐based chemotherapy regimen and standard of care treatment, along with sham acupuncture administered every other day, three times per week; treatment will be discontinued upon loss of clinical benefit, unacceptable toxicity, patient or physician decision to discontinue treatment, or death.; CONDITION: Gastric cancer and colorectal cancer PRIMARY OUTCOME: Grade of oxaliplatin‐induced peripheral neuropathy; SECONDARY OUTCOME: 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; 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 ana
Epistemonikos ID: 7ae2ebca544702fae54496c5d40cfcfe461e8cc9
First added on: May 09, 2026