Chinese Medicine External Treatment Of Chemotherapy Limbs Pain Of The Randomized, Double-blind, Controlled, Multicenter Clinical Study

There are two review articles about chemotherapy induced peripheral neuropathy. The first one reviewed the pre-clinical and clinical research about incidence characteristics and assessment of chemotherapy induced peripheral neuropathy, the second one is about the prevention and treatment for chemotherapy induced peripheral neuropathy. They mainly conclude clinical features, mechanisms, risk factors and predictors, assessment of patients, and the development of management in Traditional Chinese Medicine and Western Medicine. Analysis by synthesis, many different anticancer agents may cause chemotherapy induced peripheral neuropathy, such as platinum salts, taxanes, vinca alkaloids, bortezomib, thalidomide and analogs. Chemotherapy induced peripheral neurotoxicity is a common, potentially severe and dose-limiting adverse effect of cancer treatment. Chemotherapy induced peripheral neurotoxicity can profoundly affect the quality of life, often compelling clinicians to lower the chemotherapy regimen, consequently limiting therapeutic efficacy. The characteristics of chemotherapy induced peripheral neuropathy (type and seriousness) are related to dose intensity, cumulative dose and anticancer drug. Numerous associated factors promote the onset of neuropathy. The toxic mechanisms are not fully understood but are known to vary between anticancer drugs, affecting either dorsal root ganglia or the peripheral nerves of the peripheral nervous system. Several studies have approached the clinically relevant issue of identification of risk factors and/or predictors of the onset, course or long-term persistence of chemotherapy induced peripheral neuropathy, however, the results have been conflicting and, overall, inconclusive. Possible risk factors or predictors for a more severe chemotherapy induced peripheral neuropathy course include age, sex, comorbidities, changes in the levels of circulating growth factors, pre-existing peripheral neuropathy, and previous treatment with potentially neurotoxic antineoplastic drugs. Assessment of patients mainly use the clinical scales, the occurrence and severity of chemotherapy induced peripheral neuropathy is assessed by means of common toxicity criteria scales developed by the US national Cancer institute, which is most widely used. Semiquantitative assessment, neurophysiological investigation, neuroimaging, pathological evaluation and composite scales, are also can be used to evaluate the status of CIPN.The second part is a clinical study. Objective:The Randomized trial was designed to evaluate the efficacy and safety of the external use of Wenjing Tongluo Huoxue treatment, versus placebo for peripheral neurotoxicity (CIPN) and hand-foot syndrome (HFS) caused by chemotherapy. Methods:Eligible patients (pts) with CIPN/HFS grade≥l (NCI-CTCAE, v3.0) after oxaliplatin/capecitabine therapy. Pts were randomly assigned2:1to receive external compound Chinese herbal extract (Arm1) versus placebo (Arm2). Pts soaked their hands and feet in Chinese herbal extract or placebo lotion for20minutes, twice daily for7days. Results:204pts from3centers were enrolled. Arms were well balanced. In Arm1/Arm2, total response rate for pain was88.06%/42.65%, the mean score of pain measurement ((NRS scale of0-10) before and after treatment were5.51±1.99and2.20±2.20in Arm1,5.57±1.82and4.50±1.44in Arm2. Total response rate for CIPN/HFS Grade was81.34%/26.47%. The average time from therapy beginning to pain relieve in Arm1was4.15±0.23days. Conclusions:The external use of Wenjing Tongluo Huoxue treatment can treat CIPN/HFS, which is especially effective for relieving pain, can improve QoL of pts, easy useand safe.