***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    Input: Purpose Oxaliplatin-induced peripheral neurotoxicity ( OPN ) is frequent and potentially severe , but successful treatment of this condition is still an unmet clinical need . We aim ed to determine whether treatment with goshajinkigan ( TJ-107 ) , a traditional Japanese medicine , is better than placebo in preventing OPN in patients with advanced or recurrent colorectal cancer patients treated with st and ard FOLFOX regimens . Methods In this phase 2 , r and omized , double-blind , placebo-controlled study , patients undergoing oxaliplatin-based chemotherapy were r and omized to receive either oral TJ-107 ( 7.5 g ) or matching placebo daily . The severity of OPN  was assessed according to the  Common Toxicity Criteria for Adverse Events at baseline , every 2 weeks until the 8th cycle , and every 4 weeks thereafter until the 26th week . The primary endpoint was the incidence of grade 2 or greater OPN until the 8th cycle of chemotherapy . Results Analyses were done by intention to treat . Eighty-nine patients were r and omly assigned to receive either TJ-107  ( n = 44 ) or placebo  ( n = 45 ) between May 2009 and March 2010 . The incidence of grade 2 or greater OPN until the 8th cycle was 39 and 51 % in the TJ-107 and placebo groups , respectively ( relative risk ( RR ) , 0.76 ; 95 % CI , 0.47–1.21 ) . The incidence of grade 3 OPN was 7 % ( TJ-107 ) vs. 13 % ( placebo ) ( 0.51 , 0.14–1.92 ) . No concerns regarding toxicity emerged with TJ-107 treatment . Conclusions TJ-107 appears to have an acceptable safety margin and a promising effect in delaying the onset of grade 2 or greater OPN without impairing FOLFOX efficacy IMPORTANCE There are no known effective treatments for painful chemotherapy-induced peripheral neuropathy . OBJECTIVE To determine the effect of duloxetine , 60 mg daily , on average pain severity . DESIGN , SETTING , AND PATIENTS R and omized , double-blind , placebo-controlled crossover trial at 8 National Cancer Institute (NCI)-funded cooperative research networks that enrolled 231 patients who were 25 years or older being treated at community and academic setting s between April 2008 and March 2011 . Study follow-up was completed July 2012 . Stratified by chemotherapeutic drug and comorbid pain risk , patients were r and omized to receive either duloxetine followed by placebo or placebo followed by duloxetine .  Eligibility required that patients have grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events and at least 4 on a scale of 0 to 10 , representing average chemotherapy-induced pain , after paclitaxel , other taxane , or oxaliplatin treatment . INTERVENTIONS The initial treatment consisted of taking 1 capsule daily of either 30 mg of duloxetine or placebo for the first week and 2 capsules of either 30 mg of duloxetine or placebo daily for 4 additional weeks . MAIN OUTCOME MEASURES The primary hypothesis was that duloxetine would be more effective than placebo in decreasing chemotherapy-induced peripheral neuropathic pain . Pain severity was assessed using the Brief Pain Inventory-Short Form " average pain " item with 0 representing no pain and 10 representing as bad as can be imagined . RESULTS Individuals receiving duloxetine as their initial 5-week treatment reported a mean decrease in average pain of 1.06 ( 95 % CI , 0.72 - 1.40 ) vs 0.34 ( 95 % CI , 0.01 - 0.66 ) among those who received placebo ( P = .003 ; effect size , 0.513 ) . The observed mean difference in the average pain score between duloxetine and placebo was 0.73 ( 95 % CI , 0.26 - 1.20 ) . Fifty-nine percent of those initially receiving duloxetine vs 38 % of those initially receiving placebo reported decreased pain of any amount . CONCLUSION AND RELEVANCE Among patients with painful chemotherapy-induced peripheral neuropathy , the use of duloxetine compared with placebo for 5 weeks result ed in a greater reduction in pain . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00489411 Background Peripheral sensory neurotoxicity is a frequent adverse effect of oxaliplatin therapy . Calcium and magnesium ( Ca/Mg ) infusions are frequently used as preventatives , but a recent phase III trial failed to show that they prevent neurotoxicity . We therefore conducted a multicenter r and omized phase III trial to compare fluorouracil , leucovorin , and oxaliplatin ( mFOLFOX6 ) with and without Goshajinkigan ( GJG ) , a traditional Japanese herbal medicine ( Kampo ) , to determine GJG ’s potential for reducing peripheral neuropathy in patients with colorectal cancer . Methods Patients with colon cancer who were undergoing adjuvant therapy with infusional mFOLFOX6  were r and omly assigned to GJG ( 7.5 mg three times daily ) or placebo in a double-blind manner . The primary endpoint was the time to grade 2 or greater neuropathy , which was determined at any point during or after oxaliplatin-based therapy using version 3 of the National Cancer Institute Common Terminology Criteria for Adverse Events ( NCI CTCAE ) . Findings An interim analysis was performed when 142 of the planned 310 patients had been enrolled and the safety assessment committee recommended that the study be discontinued . One hundred eighty-two patients were evaluable for response . They included 89 patients in the GJG group and 93 patients in the placebo group . The incidence of grade 2 or greater neurotoxicity was 50.6 % in the GJG group and 31.2 % in the placebo group . A Cox proportional hazards analysis indicated that the use of GJG was significantly associated with the incidence of neuropathy ( hazard ratio , 1.908 ; p = 0.007 ) . Conclusion Goshajinkigan did not prevent oxaliplatin-associated peripheral neuropathy in this clinical trial . The clinical study was therefore terminated IMPORTANCE Chemotherapy-induced peripheral neuropathy ( CIPN ) is a common adverse effect of neurotoxic chemotherapy result ing in pain , sensory loss , and decreased quality of life . Few studies have prospect ively examined the relationship between sensory neuropathy symptoms , falls , and fall-related injuries for patients receiving neurotoxic chemotherapy .  OBJECTIVE To determine the association between the symptoms of CIPN and the risk of falls for patients receiving neurotoxic chemotherapy .  DESIGN , SETTING , AND PARTICIPANTS In this secondary analysis of a prospect i ve study , 116 patients with breast , ovarian , or lung cancer who were beginning neurotoxic chemotherapy with a taxane or platinum agent were recruited from oncology clinics . These patients would call a novel automated telephone system daily for 1 full course of chemotherapy . The telephone system ( SymptomCare@Home ) used a series of relevant CIPN questions to track symptoms on a 0 to 10 ordinal scale and contained a question naire about falls . Those reporting a numbness and tingling severity score of 3 or greater for at least 10 days were considered to have significant CIPN symptoms and were compared with those patients who did not . Data analysis was performed in November 2015 . EXPOSURE Chemotherapy with a neurotoxic taxane or platinum agent . MAIN OUTCOMES AND MEASURES Patient-reported falls or near falls and fall-related injuries . The hypothesis was generated after data collection but prior to data analysis . RESULTS Of the 116 patients who started neurotoxic chemotherapy ( mean [ SD ] age was 55.5 [ 11.9 ] years , and 109 [ 94.0 % ] were female ) , 32 met the predetermined criteria for CIPN symptoms . The mean duration of follow-up was 62 days , with 51 telephone calls completed per participant . Seventy-four falls or near falls were reported . The participants with CIPN symptoms were nearly 3 times more likely to report a fall or near fall than the participants without CIPN symptoms ( hazard ratio , 2.67 [ 95 % CI , 1.62 - 4.41 ] ; P < .001 ) . The participants with CIPN symptoms were more likely than the participants without CIPN symptoms to obtain medical care for falls ( 8 of 32 participants with CIPN symptoms [ 25.0 % ] vs 6 of 84 participants without CIPN symptoms [ 7.1 % ] ; P = .01 ) . CONCLUSIONS AND RELEVANCE These findings suggest that the sensory symptoms of CIPN are an indicator of an increased risk of falling and an increased use of health care re sources . This study demonstrates the utility of a novel telephone-based system to track neuropathy symptoms . Careful monitoring and coaching of patients receiving neurotoxic chemotherapy  for new sensory symptoms may facilitate more effective fall prevention strategies Goshajinkigan , a herbal medicine , has long been used in Japan to alleviate the subjective symptoms of diabetic neuropathy ; however , its effects have not been confirmed objective ly . We evaluated its effects on subjective symptoms and on vibration sensation in patients with diabetic neuropathy . The oral administration of 7.5 g/day of Goshajinkigan for 3 months ( treatment period ) relieved subjective symptoms of numbness in 9 of 13 patients . When the drug was discontinued for 2 months as a washout period , the subjective symptom worsened in 7 of 13 patients . Chi-square analysis revealed significant effects of Goshajiniagan on subjective symptoms ( P < 0.001 for numbness and P < 0.05 for cold sensation ) . Vibration sensation was evaluated by measuring vibratory threshold using an SMV-5 vibrometer . There were significant changes in vibratory thresholds by paired t-test ( P < 0.05 ) both in the upper and the lower extremities during the treatment and washout periods . Chi-square analysis also revealed a significant effect of Goshajinkigan on vibratory threshold ( P < 0.01 ) . There was no significant change in glycosylated hemoglobin as a whole during the study . These observations confirm that Goshajinkigan relieves subjective symptoms and demonstrate that it improves vibration sensation in patients with diabetic neuropathy BACKGROUND Goshajinkigan ( GJG ) is used for the treatment of several neurological symptoms . We investigated the efficacy of GJG and mecobalamin ( B12 ) against neurotoxicity associated with docetaxel ( DOC ) in breast cancer patients . MATERIAL S AND METHODS Sixty breast cancer patients were treated with DOC . Thirty-three patients ( GJG group ) received oral administration of 7.5 g/day GJG and 27 patients ( B12 group ) received oral administration of 1500 μg/day B12 .  Neuropathy was evaluated according to DEB-NTC ( Neurotoxicity Criteria of Debiopharm ) , Common Terminology Criteria for Adverse Events ( NCI-CTC ) ver . 3.0 , and a visual analogue scale ( VAS ) . This study employed a r and omized open design . RESULTS The incidence of neuropathy was 39.3 % in the GJG group , and 88.9 % in the B12 group ( p<0.01 ) . In the GJG group , grade 1 DEB-NTC was observed in 2 cases , grade 2 in 5 cases and grade 3 in 5 cases . Grade 1 NCI-CTC was observed in 7 cases , grade 2 in 6 cases , and VAS was 2.7 ± 2.2 . In the B12 group , grade s 1 , 2 and 3 DEB-NTC were observed in one case , 12 cases and 12 cases , respectively ; and grade s 1 , 2 and 3 NCI-CTC were observed in 11 cases , 12 cases and one case , and VAS was 4.9 ± 2.4 . CONCLUSIONS Concomitant administration of GJG is useful in preventing neuropathy in breast cancer patients treated with a DOC regimen 
    Output:
    
Conclusions Goshajinkigan tended to prevent persistence but not severity of CIPN .