human
***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 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: A double-blind trial was conducted in 138 patients with superficial transitional cell carcinoma of the bladder following transurethral resection to evaluate the prophylaxis of recurrence by an oral Lactobacillus casei preparation ( BLP ) . Patients were stratified into the following 3 subgroups : ( A ) with primary multiple tumors ; ( B ) with recurrent single tumors , and ( C ) with recurrent multiple tumors . In each group , patients were r and omly allocated to receive BLP or placebo . BLP showed a better prophylactic effect in subgroups A and B than placebo , whereas no significant difference was observed in subgroup C. Cox multivariate analysis showed that the outcome with BLP  was significantly better than with placebo ( p = 0.01 ) . Slight and tolerable adverse reactions occurred in 3 patients receiving BLP and in 3 of the placebo-treated patients . Oral administration of BLP was thus safe and effective for preventing recurrence of superficial bladder cancer BACKGROUND & AIMS Radical radiation therapy is commonly used for treatment of pelvic cancer . Up to 80 % of patients receiving radiotherapy will develop acute radiation induced diarrhea . The primary aim of this r and omized double blind controlled trial is to evaluate the effect of the probiotic Bifilact ( ® ) on moderate and severe treatment-induced diarrhea during pelvic radiation . METHODS Patients with pelvic cancers were treated between 2006 and 2010 at L'Hôtel-Dieu de Québec , University Health Center . Some patients had surgery before pelvic radiotherapy and some received chemotherapy .  A total of 246 Patients were r and omized between a placebo and either of two regiments of double strain Bifilact ( ® ) probiotics ( Lactobacillus acidophilus LAC-361 and Bifidobacterium longum BB-536 ) : a st and ard dose twice a day ( 1.3 billion CFU ) or a high dose three times a day ( 10 billion CFU ) . Patients were trained to record their digestive symptoms daily with a st and ardized scale and they met a registered dietician and radiation oncologist every week during treatment . The main analysis compared time to first appearance of grade ≥2 - 3 - 4 diarrhea using Kaplan-Meier curves as measured by proportion of patients without moderate and severe diarrhea . RESULTS 229 patients were analyzed . The difference between the groups for overall grade 2 - 3 - 4 diarrhea was not statistically significant ( p = 0.13 ) . However at 60 days , the proportion of patients without moderate and severe diarrhea in the st and ard dose group ( 35 % ) was more than twice as high as that of the placebo group ( 17 % ) with a hazard ratio of 0.69 ( p = 0.04 ) . In patients who had surgery , the st and ard probiotics dose group had a better proportion of patients without very severe diarrhea than the placebo group , respectively 97 % and 74 % ( p = 0.03 ) . In all groups , the average number of bowel movements per day during treatment was less than 3 soft stools ( p = 0.80 ) and the median abdominal pain less than 1 based on the National Cancer Institute scale ( p = 0.23 ) . CONCLUSION St and ard dose of Bifilact ( ® ) may reduce radiation induced grade 2 - 3 - 4 diarrhea at the end of the treatment of patients with pelvic cancer . In patients operated on before RT , a st and ard dose of probiotics may reduce radiation induced grade 4 diarrhea . Nutritional interventions by a registered dietician seemed to reduce global digestive symptoms . TRIAL REGISTRATION clinical trials.gov . Identifier NCT01839721 PURPOSE Diarrhea is one of the dose limiting toxicity of irinotecan . SN-38 is main irinotecan metabolite responsible for diarrhea development , which is excreted in glucuroni date d form into the intestine . This study aim ed to determine the effectiveness of the probiotics in the prevention of irinotecan induced diarrhea due to reduction of intestinal beta-d-glucuronidase activity . METHODS Between January 2011 and December 2013 , 46 patients with colorectal cancer starting a new line of irinotecan based therapy were included . Patients were r and omized 1:1 to probiotics ( PRO ) or placebo ( PLA ) . Probiotic formula Colon Dophilus ™ , was administered at a dose of 10 × 10(9)CFU of bacteria tid , orally for 12 weeks of chemotherapy . The study was prematurely terminated due to slow accrual , when 46 of 220 planned patients were accrued . RESULTS Twenty-three patients were r and omized to PRO and 23 patients to PLA . Administration of probiotics compared to placebo led to a reduction in the incidence of severe diarrhea of grade 3 or 4 ( 0 % for PRO vs. 17.4 % for PLA , p=0.11 ) , as well as reduction of the overall incidence of diarrhea ( 39.1 % for PRO vs. 60.9 % for PLA , p=0.24 ) and incidence of enterocolitis ( 0 % for PRO vs. 8.7 % for PLA ) . Patients on PRO  used less antidiarrheal drugs compared to PLA . There was no infection caused by probiotic strains recorded . CONCLUSIONS Administration of probiotics in patients with colorectal cancer treated with irinotecan-based chemotherapy is safe and could lead to a reduction in the incidence and severity of gastrointestinal toxicity BACKGROUND ARCHER 1042 , a r and omized phase II trial , explored the impact of prophylactic treatment on select dermatologic adverse events of interest ( SDAEI ) , diarrhea , and mucositis associated with dacomitinib , an oral irreversible pan-human epidermal growth factor receptor ( HER ) inhibitor , in development for advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS Patients with advanced NSCLC treated with dacomitinib were enrolled in two cohorts . Cohort I patients were r and omized 1:1 to receive oral doxycycline or placebo ( 4 weeks ) . Cohort II patients  received oral VSL#3 probiotic plus topical alclometasone . Primary end points for Cohorts I and II were incidence of all grade and grade ≥2 SDAEI in the first 8 weeks of treatment and quality of life ( QoL ) assessed by the Skindex-16 survey . Additional primary end points for Cohort II were incidence of all grade and grade ≥2 diarrhea and mucositis in the first 8 weeks of treatment ; QoL regarding diarrhea and mucositis incidence was assessed by the modified-Oral Mucositis Daily Question naire . RESULTS Cohort I r and omized 114 evaluable patients : 56 in the doxycycline arm , 58 in the placebo arm . Cohort II enrolled 59 evaluable patients .  Doxycycline significantly reduced the incidence of grade ≥2 SDAEI by 50 % ( P = 0.016 ) compared with placebo . The incidence of all grade SDAEI was lower with doxycycline than with placebo but did not reach statistical significance . Doxycycline was associated with less deterioration in QoL compared with placebo . Alclometasone was associated with less deterioration in QoL  compared with placebo but did not statistically significantly reduce the incidence of all grade or grade ≥2 SDAEI . VSL#3 did not reduce the incidence of all grade or grade ≥2 diarrhea and did not impact mucositis scores . CONCLUSIONS Doxycycline was effective as a prophylactic treatment for dacomitinib-induced grade ≥2 SDAEI . Both doxycycline and alclometasone reduced the negative impact in patient-reported dermatologic AEs . The probiotic was not effective for preventing diarrhea or mucositis Chemotherapy-induced diarrhea ( cid ) is a common side effect of cancer treatment and can cause significant morbidity and mortality . Diarrhea is frequently severe enough to require a dose reduction of , a delay in , or a discontinuation of chemotherapy . Diarrhea-associated mortality has been reported to be as high as 3.5 % in clinical trials of irinotecan and bolus 5-fluorouracil in colorectal cancer . The frequency of cid and its impact on patient management are frequently under-recognized in clinical practice . A Canadian working group , consisting of medical oncologists and an oncology pharmacist , was formed in 2001 to review the optimal approach to managing cid and to identify and implement new areas of research . The recommendations that follow are the result of the group ’s work . Acute medical management of cid includes loperamide or diphenoxylate as first-line agents . Subcutaneous octreotide is recommended for intractable grade 2 diarrhea and may be considered for grade 1 cid that does not resolve with high-dose loperamide . Hospitalization is recommended for patients with grade s 3 and 4 cid ; in-hospital care includes rehydration , antibiotic therapy , and octreotide . A chemotherapy dose reduction is generally advised for patients who have experienced grade 3 or 4 diarrhea in a previous chemotherapy cycle . If a dose reduction is not desired , prophylaxis with intramuscular long-acting release octreotide may be considered . The foregoing recommendations are based on expert opinion and require validation in prospect i ve clinical trials BACKGROUND & AIMS Bowel mucosal injury associated with 5-fluorouracil ( 5-FU ) treatment might result in secondary lactose intolerance . The frequency and clinical significance of 5-FU-related hypolactasia are unknown . METHODS One hundred fifty patients r and omly assigned to receive 1 of 2 adjuvant 5-FU-based chemotherapy regimens , the Mayo regimen or the simplified de Gramont regimen  , were studied for lactose tolerance by using an oral  lactose  absorption test , a symptom question naire , treatment-related toxicity , and Subjective Global Assessment of Nutritional Status question naire before , during , and 2 and 6 months after  chemotherapy for colorectal cancer . RESULTS The frequency of hypolactasia increased from 24 % before treatment to 35 % during treatment ( P < 0.0001 ) . Therapy-related hypolactasia was reversible on discontinuation of chemotherapy . Symptoms compatible with lactose intolerance occurred in 94 % of patients with an abnormal lactose absorption test result during chemotherapy . The frequency of hypolactasia increased during chemotherapy in both treatment groups , but was detected more commonly in those for whom therapy included continuous 5-FU infusions ( the de Gramont regimen ; 45 % vs. 25 % ; P = 0.006 ) . The presence of hypolactasia during chemotherapy was associated with flatulence , diarrhea , and poor nutritional status . CONCLUSIONS Reversible chemotherapy-related hypolactasia and lactose intolerance are not infrequent in patients treated with 5-FU-based adjuvant chemotherapy for colorectal cancer . Avoidance of lactose during chemotherapy may improve treatment tolerability in these patients Background Radiation-induced diarrhea is frequently observed during pelvic radiotherapy . This study was performed to determine the ability of a probiotic containing live lactobacillus acidophilus plus bifidobacterium bifidum to reduce the incidence of radiation-induced diarrhea in locally advanced cervical cancer patients . Methods Patients who were undergoing pelvic radiotherapy concurrent with weekly cisplatin  were r and omly assigned to a study drug or placebo , in a double-blind study . Diarrhea was grade d weekly according the Common Toxicity Criteria ( CTC ) system . Stool consistency and white and red blood cell count in stool were also assessed . The primary endpoint was to reduce the incidence of diarrhea , defined by a CTC grade 2 or more , and the need for anti-diarrheal medication . Results A total of 63 patients were enrolled .  Grade 2 -3 diarrhea was observed in 45 % of the placebo group ( n = 31 ) and 9 % of the study drug group ( n = 32 ) ( p = 0.002 ) . Anti-diarrheal medication use was significantly reduced in the placebo group ( p = 0.03 ) . The patients in the study drug group had a significantly improved stool consistency ( p < 0.001 ) . Conclusions Live lactobacillus acidophilus plus bifidobacterium bifidum reduced the incidence of radiation-induced diarrhea and the need for anti-diarrheal medication and had a significant benefits on stool consistency The clinical efficacy of LC9018 , a biological response modifier prepared from heat‐killed Lactobacillus casei YIT9018 , used in combination with radiation was studied in a r and omized controlled trial on 61 patients with carcinoma of the uterine cervix of Stage IIB or III . The combination therapy with LC9018 demonstrated a significant effect on tumor reduction , compared with radiation therapy alone , at the cumulative doses of 15‐Gy and 30‐Gy external irradiation ( P < 0.05 ) . Histologic study confirmed that LC9018 also enhanced the therapeutic effect of the irradiation . 
    Output:
    
agent
***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 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: A double-blind trial was conducted in 138 patients with superficial transitional cell carcinoma of the bladder following transurethral resection to evaluate the prophylaxis of recurrence by an oral Lactobacillus casei preparation ( BLP ) . Patients were stratified into the following 3 subgroups : ( A ) with primary multiple tumors ; ( B ) with recurrent single tumors , and ( C ) with recurrent multiple tumors . In each group , patients were r and omly allocated to receive BLP or placebo . BLP showed a better prophylactic effect in subgroups A and B than placebo , whereas no significant difference was observed in subgroup C. Cox multivariate analysis showed that the outcome with BLP  was significantly better than with placebo ( p = 0.01 ) . Slight and tolerable adverse reactions occurred in 3 patients receiving BLP and in 3 of the placebo-treated patients . Oral administration of BLP was thus safe and effective for preventing recurrence of superficial bladder cancer BACKGROUND & AIMS Radical radiation therapy is commonly used for treatment of pelvic cancer . Up to 80 % of patients receiving radiotherapy will develop acute radiation induced diarrhea . The primary aim of this r and omized double blind controlled trial is to evaluate the effect of the probiotic Bifilact ( ® ) on moderate and severe treatment-induced diarrhea during pelvic radiation . METHODS Patients with pelvic cancers were treated between 2006 and 2010 at L'Hôtel-Dieu de Québec , University Health Center . Some patients had surgery before pelvic radiotherapy and some received chemotherapy .  A total of 246 Patients were r and omized between a placebo and either of two regiments of double strain Bifilact ( ® ) probiotics ( Lactobacillus acidophilus LAC-361 and Bifidobacterium longum BB-536 ) : a st and ard dose twice a day ( 1.3 billion CFU ) or a high dose three times a day ( 10 billion CFU ) . Patients were trained to record their digestive symptoms daily with a st and ardized scale and they met a registered dietician and radiation oncologist every week during treatment . The main analysis compared time to first appearance of grade ≥2 - 3 - 4 diarrhea using Kaplan-Meier curves as measured by proportion of patients without moderate and severe diarrhea . RESULTS 229 patients were analyzed . The difference between the groups for overall grade 2 - 3 - 4 diarrhea was not statistically significant ( p = 0.13 ) . However at 60 days , the proportion of patients without moderate and severe diarrhea in the st and ard dose group ( 35 % ) was more than twice as high as that of the placebo group ( 17 % ) with a hazard ratio of 0.69 ( p = 0.04 ) . In patients who had surgery , the st and ard probiotics dose group had a better proportion of patients without very severe diarrhea than the placebo group , respectively 97 % and 74 % ( p = 0.03 ) . In all groups , the average number of bowel movements per day during treatment was less than 3 soft stools ( p = 0.80 ) and the median abdominal pain less than 1 based on the National Cancer Institute scale ( p = 0.23 ) . CONCLUSION St and ard dose of Bifilact ( ® ) may reduce radiation induced grade 2 - 3 - 4 diarrhea at the end of the treatment of patients with pelvic cancer . In patients operated on before RT , a st and ard dose of probiotics may reduce radiation induced grade 4 diarrhea . Nutritional interventions by a registered dietician seemed to reduce global digestive symptoms . TRIAL REGISTRATION clinical trials.gov . Identifier NCT01839721 PURPOSE Diarrhea is one of the dose limiting toxicity of irinotecan . SN-38 is main irinotecan metabolite responsible for diarrhea development , which is excreted in glucuroni date d form into the intestine . This study aim ed to determine the effectiveness of the probiotics in the prevention of irinotecan induced diarrhea due to reduction of intestinal beta-d-glucuronidase activity . METHODS Between January 2011 and December 2013 , 46 patients with colorectal cancer starting a new line of irinotecan based therapy were included . Patients were r and omized 1:1 to probiotics ( PRO ) or placebo ( PLA ) . Probiotic formula Colon Dophilus ™ , was administered at a dose of 10 × 10(9)CFU of bacteria tid , orally for 12 weeks of chemotherapy . The study was prematurely terminated due to slow accrual , when 46 of 220 planned patients were accrued . RESULTS Twenty-three patients were r and omized to PRO and 23 patients to PLA . Administration of probiotics compared to placebo led to a reduction in the incidence of severe diarrhea of grade 3 or 4 ( 0 % for PRO vs. 17.4 % for PLA , p=0.11 ) , as well as reduction of the overall incidence of diarrhea ( 39.1 % for PRO vs. 60.9 % for PLA , p=0.24 ) and incidence of enterocolitis ( 0 % for PRO vs. 8.7 % for PLA ) . Patients on PRO  used less antidiarrheal drugs compared to PLA . There was no infection caused by probiotic strains recorded . CONCLUSIONS Administration of probiotics in patients with colorectal cancer treated with irinotecan-based chemotherapy is safe and could lead to a reduction in the incidence and severity of gastrointestinal toxicity BACKGROUND ARCHER 1042 , a r and omized phase II trial , explored the impact of prophylactic treatment on select dermatologic adverse events of interest ( SDAEI ) , diarrhea , and mucositis associated with dacomitinib , an oral irreversible pan-human epidermal growth factor receptor ( HER ) inhibitor , in development for advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS Patients with advanced NSCLC treated with dacomitinib were enrolled in two cohorts . Cohort I patients were r and omized 1:1 to receive oral doxycycline or placebo ( 4 weeks ) . Cohort II patients  received oral VSL#3 probiotic plus topical alclometasone . Primary end points for Cohorts I and II were incidence of all grade and grade ≥2 SDAEI in the first 8 weeks of treatment and quality of life ( QoL ) assessed by the Skindex-16 survey . Additional primary end points for Cohort II were incidence of all grade and grade ≥2 diarrhea and mucositis in the first 8 weeks of treatment ; QoL regarding diarrhea and mucositis incidence was assessed by the modified-Oral Mucositis Daily Question naire . RESULTS Cohort I r and omized 114 evaluable patients : 56 in the doxycycline arm , 58 in the placebo arm . Cohort II enrolled 59 evaluable patients .  Doxycycline significantly reduced the incidence of grade ≥2 SDAEI by 50 % ( P = 0.016 ) compared with placebo . The incidence of all grade SDAEI was lower with doxycycline than with placebo but did not reach statistical significance . Doxycycline was associated with less deterioration in QoL compared with placebo . Alclometasone was associated with less deterioration in QoL  compared with placebo but did not statistically significantly reduce the incidence of all grade or grade ≥2 SDAEI . VSL#3 did not reduce the incidence of all grade or grade ≥2 diarrhea and did not impact mucositis scores . CONCLUSIONS Doxycycline was effective as a prophylactic treatment for dacomitinib-induced grade ≥2 SDAEI . Both doxycycline and alclometasone reduced the negative impact in patient-reported dermatologic AEs . The probiotic was not effective for preventing diarrhea or mucositis Chemotherapy-induced diarrhea ( cid ) is a common side effect of cancer treatment and can cause significant morbidity and mortality . Diarrhea is frequently severe enough to require a dose reduction of , a delay in , or a discontinuation of chemotherapy . Diarrhea-associated mortality has been reported to be as high as 3.5 % in clinical trials of irinotecan and bolus 5-fluorouracil in colorectal cancer . The frequency of cid and its impact on patient management are frequently under-recognized in clinical practice . A Canadian working group , consisting of medical oncologists and an oncology pharmacist , was formed in 2001 to review the optimal approach to managing cid and to identify and implement new areas of research . The recommendations that follow are the result of the group ’s work . Acute medical management of cid includes loperamide or diphenoxylate as first-line agents . Subcutaneous octreotide is recommended for intractable grade 2 diarrhea and may be considered for grade 1 cid that does not resolve with high-dose loperamide . Hospitalization is recommended for patients with grade s 3 and 4 cid ; in-hospital care includes rehydration , antibiotic therapy , and octreotide . A chemotherapy dose reduction is generally advised for patients who have experienced grade 3 or 4 diarrhea in a previous chemotherapy cycle . If a dose reduction is not desired , prophylaxis with intramuscular long-acting release octreotide may be considered . The foregoing recommendations are based on expert opinion and require validation in prospect i ve clinical trials BACKGROUND & AIMS Bowel mucosal injury associated with 5-fluorouracil ( 5-FU ) treatment might result in secondary lactose intolerance . The frequency and clinical significance of 5-FU-related hypolactasia are unknown . METHODS One hundred fifty patients r and omly assigned to receive 1 of 2 adjuvant 5-FU-based chemotherapy regimens , the Mayo regimen or the simplified de Gramont regimen  , were studied for lactose tolerance by using an oral  lactose  absorption test , a symptom question naire , treatment-related toxicity , and Subjective Global Assessment of Nutritional Status question naire before , during , and 2 and 6 months after  chemotherapy for colorectal cancer . RESULTS The frequency of hypolactasia increased from 24 % before treatment to 35 % during treatment ( P < 0.0001 ) . Therapy-related hypolactasia was reversible on discontinuation of chemotherapy . Symptoms compatible with lactose intolerance occurred in 94 % of patients with an abnormal lactose absorption test result during chemotherapy . The frequency of hypolactasia increased during chemotherapy in both treatment groups , but was detected more commonly in those for whom therapy included continuous 5-FU infusions ( the de Gramont regimen ; 45 % vs. 25 % ; P = 0.006 ) . The presence of hypolactasia during chemotherapy was associated with flatulence , diarrhea , and poor nutritional status . CONCLUSIONS Reversible chemotherapy-related hypolactasia and lactose intolerance are not infrequent in patients treated with 5-FU-based adjuvant chemotherapy for colorectal cancer . Avoidance of lactose during chemotherapy may improve treatment tolerability in these patients Background Radiation-induced diarrhea is frequently observed during pelvic radiotherapy . This study was performed to determine the ability of a probiotic containing live lactobacillus acidophilus plus bifidobacterium bifidum to reduce the incidence of radiation-induced diarrhea in locally advanced cervical cancer patients . Methods Patients who were undergoing pelvic radiotherapy concurrent with weekly cisplatin  were r and omly assigned to a study drug or placebo , in a double-blind study . Diarrhea was grade d weekly according the Common Toxicity Criteria ( CTC ) system . Stool consistency and white and red blood cell count in stool were also assessed . The primary endpoint was to reduce the incidence of diarrhea , defined by a CTC grade 2 or more , and the need for anti-diarrheal medication . Results A total of 63 patients were enrolled .  Grade 2 -3 diarrhea was observed in 45 % of the placebo group ( n = 31 ) and 9 % of the study drug group ( n = 32 ) ( p = 0.002 ) . Anti-diarrheal medication use was significantly reduced in the placebo group ( p = 0.03 ) . The patients in the study drug group had a significantly improved stool consistency ( p < 0.001 ) . Conclusions Live lactobacillus acidophilus plus bifidobacterium bifidum reduced the incidence of radiation-induced diarrhea and the need for anti-diarrheal medication and had a significant benefits on stool consistency The clinical efficacy of LC9018 , a biological response modifier prepared from heat‐killed Lactobacillus casei YIT9018 , used in combination with radiation was studied in a r and omized controlled trial on 61 patients with carcinoma of the uterine cervix of Stage IIB or III . The combination therapy with LC9018 demonstrated a significant effect on tumor reduction , compared with radiation therapy alone , at the cumulative doses of 15‐Gy and 30‐Gy external irradiation ( P < 0.05 ) . Histologic study confirmed that LC9018 also enhanced the therapeutic effect of the irradiation . 
    Output:
    