***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: BACKGROUND The aim of this study was to evaluate the effectiveness of granulocyte-macrophage colony-stimulating factor ( GM-CSF ) mouthwashes in the prevention of severe mucositis induced by high doses of chemotherapy . PATIENTS AND METHODS Ninety consecutive patients affected by solid tumors and undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue were r and omized to receive placebo versus GM-CSF mouthwash 150 micro g/day . Patients were stratified on the basis of the conditioning treatment and the consequent different risk of severe oral mucositis . Treatment was administered from the day after the end of chemotherapy until the resolution of stomatitis and /or neutrophil recovery . RESULTS The statistical analyses were intention-to-treat and involved all patients who entered the study . The severity of stomatitis was evaluated daily by the physicians according to National Cancer Institute Common Toxicity Criteria . Both study and control groups were compared with respect to the frequency [ 30 % versus 36 % , chi(2 ) exact test , not significant ( NS ) ] and mean duration ( 4.8 + /- 4.7 versus 4.4 + /- 2.7 days , t-test , NS ) of severe stomatitis ( grade > or = 3 ) . Oral pain was evaluated daily by patients themselves by means of a 10 cm analog visual scale : the mean ( + /- st and ard error of the mean ) maximum mucositis scores were 4.8 + /- 3.5 versus 4.2 + /- 3.5 cm ( t-test , NS ) . Furthermore , 15/46 patients in the study group ( 33 % ) and 19/44 patients in the control group experienced pain requiring opioids ( chi(2 ) exact test , NS ) . CONCLUSION We did not find any evidence to indicate that prophylaxis with GM-CSF mouthwash can help to reduce the severity of mucositis in the setting of the patients we studied PURPOSE To compare granulocyte-macrophage colony-stimulating factor ( GM-CSF ) mouthwashes with sucralfate mouthwashes in the prevention of radiation-induced mucositis . METHODS AND MATERIAL S Forty patients with radically operated head- and -neck cancer were r and omly allocated to use either GM-CSF ( n = 21 ) or sucralfate ( n = 19 ) mouthwashes during postoperative radiotherapy ( RT ) . All patients received conventionally fractionated RT to a total dose of 50 - 60 Gy in 2-Gy daily fractions during 5 - 6 weeks to the primary site and regional lymphatics . A minimum of 50 % of the oral cavity and oropharyngeal mucosa was included in the clinical target volume . GM-CSF mouthwashes consisted of 37.5 microg GM-CSF and sucralfate mouthwashes of 1.0 g of sucralfate distilled in water . Both washes were used 4 times daily , beginning after the first week of RT and continued to the end of the RT course . Symptoms related to radiation mucositis and body weight , serum prealbumin level , and blood cell counts were monitored weekly . RESULTS Oral mucositis tended to be less severe in the GM-CSF group ( p = 0.072 ) . Complete ( n = 1 ) or partial ( n = 4 ) healing of mucositis occurred during the RT course in 5 patients ( 24 % ) in the GM-CSF group and in none of the patients in the sucralfate group ( p = 0.049 ) . Patients who received GM-CSF had less mucosal pain ( p = 0.058 ) and were less often prescribed opioids for pain ( p = 0.042 ) . Three patients in the sucralfate group needed hospitalization for mucositis during RT compared with none in the GM-CSF group . Four patients ( 21 % ) in the sucralfate group and none in the GM-CSF group required an interruption in the RT course ( p = 0.042 ) . No significant differences in weight , prealbumin level , or blood cell count were found between the groups , and both mouthwashes were well tolerated . CONCLUSION GM-CSF mouthwashes may be moderately more effective than sucralfate mouthwashes in preventing radiation-induced mucositis and mucositis-related pain , and their use may lead to less frequent RT course interruptions from mucositis . The present findings need to be confirmed before adopting GM-CSF mouthwashes in routine clinical use BACKGROUND Mucositis is one of the most frequent and severe side-effect of chemotherapy in childhood-cancer patients for which there is no prophylaxis available . The efficacy and feasibility of a TGF-beta(2)-enriched feeding for preventing oral and gastro-intestinal-mucositis in childhood-cancer patients were studied . PROCEDURE The study was design ed as a two-period cross-over , r and omized , double-blinded , placebo , controlled trial . Patients who had a high risk for developing mucositis and who would receive two comparable cycles of chemotherapy were eligible for the study . During one cycle of chemotherapy , TGF-beta(2)-enriched feeding was administered ; during the other , a " placebo " ( not enriched ) feeding was used . WHO toxicity scales of diarrhea , oral mucositis , fever , anal lesions and nausea/vomiting were scored daily . In addition , the incidence of occurrence of blood cultures , antibiotic therapy , and interventions or diagnostics related to mucositis were measured . RESULTS The feasibility of the study was good : 83 % of the patients completed two cycles and 86 % of the study -feeding was effectively consumed . Administration of TGF-beta(2 ) was safe as serum TGF-beta(2 ) did not increase , and renal and liver function were not affected during TGF-beta(2 ) consumption compared to normal feeding . Differences in toxicity , scored during the whole observation period and the number of days with WHO 3/4 toxicity , were not significantly different between cycles with TGF-beta(2 ) enriched and normal feeding . CONCLUSIONS TGF-beta(2 ) administration via feeding is well tolerated and safe . Although this study might have had limitations to show potential benefit of TGF-beta(2 ) , it does not provide evidence that TGF-beta(2 ) decreases the incidence or degree of mucositis induced by combination chemotherapy in childhood-cancer patients Conditioning therapy in connection with haematopoietic SCT ( HSCT ) induces a disruption of the intestinal barrier function facilitating the permeation of bacteria and endotoxin through the bowel wall with subsequent increased risk of septicaemia and a worsening of GVHD in the allogeneic setting . Palifermin ( recombinant human keratinocyte growth factor ) reduces the severity of oral mucositis with HSCT . The present trial investigates its effect on intestinal barrier function .  Seventeen lymphoma patients undergoing autologous HSCT received palifermin .  Intestinal permeability was assessed before the conditioning therapy and on days + 4 and + 14 . Clinical oral and gastrointestinal toxicity was prospect ively assessed in parallel . A comparison was made with matched historical study patients ( n=21 ) . Patients treated with palifermin had a significantly better preserved intestinal barrier function ( P=0.01 on day + 4 ) and were in less need of total parenteral nutrition ( P=0.005 ) as compared with controls . No significant reduction of clinical gastrointestinal or oral toxicity was observed . The intestinal barrier function , normally disrupted by the conditioning therapy , is preserved by palifermin . Whether intestinal barrier preservation protects from invasive infections , and in the allogeneic setting diminishes GVHD severity , remains to be investigated in r and omized controlled trials Oral mucositis is a frequent side effect of myeloablative chemo- and radiotherapy preceding stem cell transplantation . It causes pain , poor food intake , and is a port of entry for infection . We studied whether GM-CSF applied topically in the oral cavity can prevent or ameliorate this mucositis . In 36 consecutive patients undergoing a stem cell transplantation , we performed a double-blind placebo-controlled study of 300 µg GM-CSF in a 2 % methylcellulose gel daily versus a 2 % methylcellulose gel alone . Both were locally applied in the oral cavity . The primary end-point was mucositis as measured by the WHO toxicity scale for mucositis , oral assessment scale , and a subjective pain scale , all scored daily . The secondary end-points were need to give parenteral nutrition and morphine , incidence of fever and infections , and duration of neutropenia and hospitalization . No differences were found in the median subjective pain scores , WHO scores , and oral assessment scores between the placebo and the GM-CSF groups . In both groups , nine patients required morphine for pain control . Ten patients in the placebo group and 11 in the GM-CSF group received parenteral nutrition . Documented infections , use of broad-spectrum antibiotics , and number of days with fever were similar in the placebo and the GM-CSF groups . The duration of neutropenia below 0.5 × 109/l ( median 14.5 days in the placebo group versus 17 days in the GM-CSF group ) and the duration of hospitalization ( 28.5 versus 29 days ) was also not significantly different . We found no beneficial effect of 300 µg GM-CSF dissolved in a 2 % methylcellulose gel applied locally for chemo- and radiotherapy-induced mucositis in patients undergoing a stem cell transplantation PURPOSE Oral mucositis ( OM ) is one of the most debilitating and common side effects in patients treated with high-dose chemotherapy supported by haematopoietic stem cell transplantation ( HSCT ) . We tested the effectiveness of palifermin to avoid oral mucosal injury induced by the conditioning regimen . PATIENTS AND METHODS Twenty patients with haematological malignancies were treated with palifermin for prevention of OM during HSCT procedures . Nine patients received allogeneic haematopoietic stem cells , and in 11 autologous HSCT was performed . The control group was composed of patients who had been treated with HSCT previously , before the palifermin era . The source of graft was peripheral blood . RESULTS Among patients treated with palifermin no grade 2 - 4 OM was observed . No patient had to receive opioid analgesics or total parenteral nutrition . 30 % of the patients developed grade 1 OM of 4 - 5 days ' duration . In the control group OM was observed in all cases , with 50 % of the patients developing grade 3 - 4 OM . Median duration of OM was 10 and 12 days for auto- and allogeneic patients , respectively . In comparison with the control group , treatment with palifermin was associated with significant reduction of grade 2 - 4 OM , shorter duration of OM , less analgesics intake , and reduced number of days with antibiotic treatment . Additionally , allogeneic patients treated with palifermin had shorter time to platelet engraftment . CONCLUSION Palifermin reduces incidence , severity and duration of OM , and decreases the number of days with analgesics and antibiotics . For allogeneic patients it can shorten the time to platelet engraftment , but this observation needs further studies ATL-104 is a potent mitogen for epithelial cells of the gastrointestinal tract . In animal models , ATL-104 aids regeneration of the gastrointestinal tract after treatment with chemotherapeutic agents . The effect of ATL-104 on mucositis in patients requiring high-dose melphalan or BEAM before peripheral blood SCT ( PBSCT ) was investigated in a r and omized , placebo-controlled , double-blind , two-part study . Patients were r and omized to ATL-104  ( 50 , 100 or 150 mg ) or placebo once daily for 3 days before chemotherapy and 3 days after PBSCT . Part one of the study was a dose-escalation design ; part two was a parallel group design using all three ATL-104 doses . Patients were followed up for 28 days post-treatment . Severity of signs and symptoms were assessed and used to calculate scores for st and ard toxicity rating scales ( WHO , Western Consortium for Cancer Nursing Research ( WCCNR ) ) . Sixty-three patients were treated . Treatment with ATL-104 substantially reduced the median duration of severe oral mucositis ( WHO grade 3 or 4 ) compared with placebo ( median duration : ATL-104 groups 2 or 3 days , placebo 10.5 days ) . The effect of ATL-104 on the incidence of severe oral mucositis was inconclusive . Similar results were obtained using the WCCNR Scale . Adverse events ( AEs ) were predominantly mild or moderate in intensity . Gastrointestinal AE were most common Goals of workThe objective of this study was to evaluate the safety and tolerability of velafermin in patients at risk of developing severe oral mucositis ( OM ) from chemotherapy . Material s and methods This study was a single-center , open-label , single-dose escalation , phase I trial in patients undergoing high-dose chemotherapy ( HDCT ) and autologous peripheral blood stem cell transplant ( PBSCT ) . 
    Output:
    
Conclusions Of the cytokine and growth factor agents studied for oral mucositis , the evidence only supports use  of palifermin  in the specific population listed above .