Evaluation of topical morphine for treatment of oral mucositis in cancer patients

2020 ◽  
pp. 204946372097506
Author(s):  
Bettina Nygaard Nielsen ◽  
Susanne Molin Friis ◽  
Kjeld Schmiegelow ◽  
Steen Henneberg ◽  
Janne Rømsing
Keyword(s):  
Adverse Events ◽  
Pain Intensity ◽  
Oral Mucositis ◽  
Analgesic Effect ◽  
Morphine Consumption ◽  
Intensity Difference ◽  
Control Group ◽  
Serious Adverse Events ◽  
Pain Intensity Difference ◽  
Secondary Outcomes

Introduction: Oral mucositis is a painful side effect to chemotherapy. Orally applied opioids may offer analgesia with fewer side effects than systemic opioids. Methods: A randomized trial comparing the analgesic effect of a morphine oromucosal solution (OM) to placebo and a positive control group receiving intravenous (IV) morphine as an add-on treatment to morphine patient-controlled analgesia (PCA) in a mixed population of paediatric and adult haematology patients. All patients in the study were equipped with a morphine PCA pump and the participating patients were instructed to use this pump as an escape. Primary outcome was morphine consumption (mg/kg/hour) on the PCA pump. Secondary outcomes included pain intensity difference at rest and when performing oral hygiene, time to first PCA bolus, nutrition intake and adverse events. Findings: A total of 60 patients (38 children <18 years) were randomized. Thirty patients were allocated to morphine OM/placebo IV (group MO), 15 patients to placebo OM/morphine IV (group MI) and 15 patients to placebo OM/placebo IV (group P). The median morphine consumption in the MO group (22.7 mcg/kg/hour 95% confidence interval (CI) 19.4–29.4 mcg/kg/hour, p = 0.38) was not significantly different from the placebo group (24.6 mcg/kg/hour 95% CI 16.8–34.4 mcg/kg/hour, p = 0.44) or the MI group (13.7 mcg/kg/hour 95% CI 9.7–37.8 mcg/kg/hour). For the secondary outcomes, the analysis of summed pain intensity difference after the first, third and fourth administrations of study medication indicated a reduction in pain for the MI group compared to the P and MO groups. No serious adverse events were reported. Conclusion: The findings indicate that the analgesic effect of peripherally applied morphine is not significantly different from placebo, and parenteral opioids should continue to be the standard of care.

scholarly journals Analgesic effect of oral ibuprofen 400, 600, and 800 mg; paracetamol 500 and 1000 mg; and paracetamol 1000 mg plus 60 mg codeine in acute postoperative pain: a single-dose, randomized, placebo-controlled, and double-blind study

2021 ◽  
Author(s):  
Gaute Lyngstad ◽  
Per Skjelbred ◽  
David M. Swanson ◽  
Lasse A. Skoglund
Keyword(s):  
Single Dose ◽  
Pain Intensity ◽  
Effect Size ◽  
Analgesic Effect ◽  
Intensity Difference ◽  
Double Blind ◽  
Pain Intensity Difference ◽  
Calculated Effect ◽  
Maximum Pain ◽  
Size Estimates

Abstract Purpose Effect size estimates of analgesic drugs can be misleading. Ibuprofen (400 mg, 600 mg, 800 mg), paracetamol (1000 mg, 500 mg), paracetamol 1000 mg/codeine 60 mg, and placebo were investigated to establish the multidimensional pharmacodynamic profiles of each drug on acute pain with calculated effect size estimates. Methods A randomized, double-blind, single-dose, placebo-controlled, parallel-group, single-centre, outpatient, and single-dose study used 350 patients (mean age 25 year, range 18 to 30 years) of homogenous ethnicity after third molar surgery. Primary outcome was sum pain intensity over 6 h. Secondary outcomes were time to analgesic onset, duration of analgesia, time to rescue drug intake, number of patients taking rescue drug, sum pain intensity difference, maximum pain intensity difference, time to maximum pain intensity difference, number needed to treat values, adverse effects, overall drug assessment as patient-reported outcome measure (PROM), and the effect size estimates NNT and NNTp. Results Ibuprofen doses above 400 mg do not significantly increase analgesic effect. Paracetamol has a very flat analgesic dose–response profile. Paracetamol 1000/codeine 60 mg gives similar analgesia as ibuprofen from 400 mg, but has a shorter time to analgesic onset. Active drugs show no significant difference in maximal analgesic effect. Other secondary outcomes support these findings. The frequencies of adverse effects were low, mild to moderate in all active groups. NNT and NTTp values did not coincide well with PROMs. Conclusion Ibuprofen doses above 400 mg for acute pain offer limited analgesic gain. Paracetamol 1000 mg/codeine 60 mg is comparable to ibuprofen doses from 400 mg. Calculated effect size estimates and PROM in our study seem not to relate well as clinical analgesic efficacy estimators. Trial registration NCT00699114.

scholarly journals Efficacy and safety of remdesivir in COVID-19 caused by SARS-CoV-2: a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048416
Author(s):  
Surjit Singh ◽  
Daisy Khera ◽  
Ankita Chugh ◽  
Pushpinder Singh Khera ◽  
Vinay Kumar Chugh
Keyword(s):  
Respiratory Failure ◽  
Adverse Events ◽  
Clinical Improvement ◽  
Meta Analysis ◽  
Control Group ◽  
Mortality Benefit ◽  
Serious Adverse Events ◽  
Registration Number ◽  
Secondary Outcomes ◽  
Quality Evidence

ObjectivesEvaluation of remdesivir, an RNA polymerase inhibitor, for effectiveness in adults with COVID-19.Data sourcesElectronic search for eligible articles of PubMed, Cochrane Central and clinicaltrials.gov was performed on 20 September 2020.Participants and study eligibility criteriaOnly randomised controlled trials (RCTs) evaluating efficacy of remdesivir in COVID-19 were included for meta-analysis.InterventionsRemdesivir was compared with standard of care.Primary and secondary outcomesPrimary outcome was mortality and secondary outcomes were time to clinical improvement and safety outcomes like serious adverse events, respiratory failure.Study appraisal and synthesis methodsData synthesis was done with Cochrane review manager 5 (RevMan) V.5.3. Cochrane risk of bias V.2.0 tool was used for methodological quality assessment. The GRADE pro GDT was applied for overall quality of evidence.Results52 RCTs were screened and 4 studies were included in analysis, with total of 7324 patients. No mortality benefit was observed with remdesivir versus control group (OR=0.92 (95% CI 0.79 to 1.07), p=0.30, moderate quality evidence). Significantly higher rates of clinical improvement (OR=1.52 (95% CI 1.24 to 1.87), p<0.0001, low quality) and faster time to clinical improvement (HR=1.28 (95% CI 1.12 to 1.46), p=0.0002, very low quality) was observed with remdesivir versus control group. Significant decrease was found in the risk of serious adverse events (RR=0.75 (95% CI 0.62 to 0.90), p=0.0003, low quality); however, no difference was found in the risk of respiratory failure (RR=0.85 (95% CI 0.41 to 1.77), p=0.67, very low quality evidence) with remdesivir.ConclusionsAs per the evidence from current review, remdesivir has shown no mortality benefit (moderate quality evidence) in the treatment of COVID-19. From a cost–benefit perspective, it is our personal opinion that it should not be recommended for use, especially in low and lower middle income countries.Trial registration numberPROSPERO registration number: CRD42020189517.

scholarly journals The Complex Balance between Analgesic Efficacy, Change of Dose and Safety Profile Over Time, in Cancer Patients Treated with Opioids: Providing the Clinicians with an Evaluation Tool

2020 ◽  
Vol 9 (2) ◽  
pp. 502
Author(s):  
Oscar Corli ◽  
Luca Porcu ◽  
Claudia Santucci ◽  
Cristina Bosetti
Keyword(s):  
Adverse Events ◽  
Pain Intensity ◽  
Cancer Patients ◽  
Dose Escalation ◽  
Clinical Aspects ◽  
Intensity Difference ◽  
High Dose ◽  
Pain Intensity Difference ◽  
Therapeutic Decisions ◽  
Daily Dose

Background: Scanty data exist on the integration between the analgesic effect of opioids, dose changes, and adverse events in cancer patients. Methods: To provide further information on this issue, we analysed data on 498 advanced-stage cancer patients treated with strong opioids. At baseline and three visits (at days 7, 14, and 21), pain intensity, oral morphine-equivalent daily dose, and the prevalence of major adverse events were measured. The proportion of responders (pain intensity decrease ≥30% from baseline) and non-responders, as well as of patients with low or high dose escalation, was calculated. Results: Pain intensity strongly decreased from baseline (pain intensity difference −4.0 at day 7 and −4.2 at day 21) in responders, while it was quite stable in non-responders (pain intensity difference −0.8 at day 7 and −0.9 at day 21). In low dose escalation patients (82.4% at final visit), daily dose changed from 52.3 to 65.3 mg; in high dose escalation patients (17.6%), it varied from 94.1 to 146.7 mg. Among responders, high dose escalation patients experienced significantly more frequent adverse events compared to low or high dose escalation patients, while no differences were observed in non-responders. Conclusions: The response to opioids results from the combination of three clinical aspects, which are strongly interrelated. These results provide some thoughts to help clinical evaluations and therapeutic decisions regarding opioid use.

scholarly journals Intravenous Lidocaine: Old-School Drug, New Purpose—Reduction of Intractable Pain in Patients with Chemotherapy Induced Peripheral Neuropathy

2017 ◽  
Vol 2017 ◽  
pp. 1-9 ◽  
Author(s):  
Sandra A. S. van den Heuvel ◽  
Selina E. I. van der Wal ◽  
Lotte A. Smedes ◽  
Sandra A. Radema ◽  
Nens van Alfen ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Analgesic Effect ◽  
Intensity Difference ◽  
Control Group ◽  
Intractable Pain ◽  
Pain Intensity Difference ◽  
Sensory Abnormalities ◽  
Long Term Effect ◽  
Pressure Pain Thresholds

Background. Treatment of intractable pain due to chemotherapy induced peripheral neuropathy (CIPN) is a challenge. Intravenous (iv) lidocaine has shown to be a treatment option for neuropathic pain of different etiologies. Methods. Lidocaine (1.5 mg/kg in 10 minutes followed by 1.5 mg/kg/h over 5 hours) was administered in nine patients with CIPN, and analgesic effect was evaluated during infusion and after discharge. The immediate effect of lidocaine on pressure pain thresholds (PPT) and the extent of the stocking and glove distribution of sensory abnormalities (cold and pinprick) were assessed. Results. Lidocaine had a significant direct analgesic effect in 8 out of 9 patients (P=0.01) with a pain intensity difference of >30%. Pain reduction persisted in 5 patients for an average of 23 days. Lidocaine did not influence mean PPT, but there was a tendency that the extent of sensory abnormalities decreased after lidocaine. Conclusion. Iv lidocaine has direct analgesic effect in CIPN with a moderate long-term effect and seems to influence the area of cold and pinprick perception. Additional research is needed, using a control group and larger sample sizes to confirm these results.

Dreierkombination (Thomapyrin®) ist wirksamer bei Kopfschmerzen als Monosubstanzen und Zweierkombination

2005 ◽  
Vol 24 (07) ◽  
pp. 626-639 ◽  
Author(s):  
V. Pfaffenrath ◽  
L. Pageler ◽  
H. Peil ◽  
B. Aicher ◽  
H. C. Diener
Keyword(s):  
Pain Intensity ◽  
Visual Analog Scale ◽  
A Priori ◽  
Intensity Difference ◽  
Visuelle Analogskala ◽  
Analog Scale ◽  
Pain Intensity Difference

ZusammenfassungDie Wirksamkeit, Sicherheit und Verträglichkeit einer Einzelgabe von zwei Tabletten der fixen Dreierkombination mit 250 mg Azetylsalizylsäure (ASS) plus 200 mg Paracetamol plus 50 mg Koffein (Thomapyrin®) gegenüber zwei Tabletten mit 500 mg ASS, oder zwei Tabletten mit 500 mg Paracetamol, oder zwei Tabletten mit 50 mg Koffein beziehungsweise Plazebo wurde in einer klinischen Studie an 1 743 Patienten geprüft, die ihre episodischen Kopfschmerzen vom Spannungstyp oder ihre Migräne mit und ohne Aura üblicherweise erfolgreich mit verschreibungsfreien Analgetika behandeln. Die Dreierkombination war im a priori definierten primären Endpunkt “Zeit bis zu 50% Schmerzreduktion” sowohl der Zweierkombination aus ASS plus Paracetamol (p = 0,0181), als auch den Monoanalgetika ASS (p = 0,0398) und Paracetamol (p = 0,0016), sowie auch der Monotherapie mit Koffein (p < 0,0001) und Plazebo (p < 0,0001) überlegen. Alle Behandlungen außer der Koffein-Monotherapie waren der Plazebobehandlung überlegen (p < 0,0001). Die überlegene Wirksamkeit der Dreierkombination gilt auch für alle sekundären Endpunkte wie beispielsweise der “Verringerung der Kopfschmerzen auf 10 mm VAS (visual analog scale = visuelle Analogskala zur Schmerzmessung), dem gewichteten % SPID (sum of pain intensity difference = aufsummierte Schmerzintensitätsdifferenz gegenüber dem Ausgangsschmerz in Prozent), dem Ausmaß der Beeinträchtigung der alltäglichen Aktivitäten und der globalen Beurteilung der Wirksamkeit durch die Patienten. Alle Behandlungen waren gut verträglich, die Inzidenz von unerwünschten Begleiterscheinungen war gering.

EXPRESS: Altering the rehabilitation environment to improve stroke survivor activity (AREISSA): a Phase II trial.

2021 ◽  
pp. 174749302110069
Author(s):  
Heidi Janssen ◽  
Louise Ada ◽  
Sandy Middleton ◽  
Michael Pollack ◽  
Michael Nilsson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Outcomes ◽  
Environmental Enrichment ◽  
Brain Plasticity ◽  
Social Activity ◽  
Stroke Survivor ◽  
Group Differences ◽  
Control Group ◽  
Serious Adverse Events ◽  
Clinical Trial Registration

Background: Environmental enrichment involves organisation of the environment and provision of equipment to facilitate engagement in physical, cognitive and social activity. In animals with stroke, it promotes brain plasticity and recovery. Aims: To assess the feasibility and safety of a patient-driven model of environmental enrichment incorporating access to communal and individual environmental enrichment. Methods: A non-randomised cluster trial with blinded measurement involving people with stroke (n=193) in 4 rehabilitation units was carried out. Feasibility was operationalised as activity 10 days after admission to rehabilitation and availability of environmental enrichment. Safety was measured as falls and serious adverse events. Benefit was measured as clinical outcomes at 3 months, by an assessor blinded to group. Results: The experimental group (n=91) spent 7% (95% CI -14 to 0) less time inactive, 9% (95% CI 0 to 19) more time physically, and 6% (95% CI 2 to 10) more time socially active than the control group (n=102). Communal environmental enrichment was available 100% of the time, but individual environmental enrichment was rarely within reach (24%) or sight (39%). There were no between-group differences in serious adverse events or falls at discharge or 3 months nor in clinical outcomes at 3 months. Conclusions: This patient-driven model of environmental enrichment was feasible and safe. However, the very modest increase in activity by people with stroke, and the lack of benefit in clinical outcomes 3 months after stroke do not provide justification for an efficacy trial. Clinical Trial Registration: ANZCTR 12613000796785 Words: 245

scholarly journals Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis

2019 ◽  
Vol 54 (18) ◽  
pp. 1073-1080 ◽  
Author(s):  
Andre Niemeijer ◽  
Hans Lund ◽  
Signe Nilssen Stafne ◽  
Thomas Ipsen ◽  
Cathrine Luhaäär Goldschmidt ◽  
...  
Keyword(s):  
Systematic Review ◽  
Relative Risk ◽  
Adverse Events ◽  
Exercise Therapy ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Randomised Controlled

ObjectiveTo evaluate the relative risk (RR) of serious and non-serious adverse events in patients treated with exercise therapy compared with those in a non-exercising control group.DesignSystematic review and meta-analysis.Data sourcesPrimary studies were identified based on The Cochrane Database of Systematic Reviews investigating the effect of exercise therapy.Eligibility criteriaAt least two of the authors independently evaluated all identified reviews and primary studies. Randomised controlled trials were included if they compared any exercise therapy intervention with a non-exercising control. Two authors independently extracted data. The RR of serious and non-serious adverse events was estimated separately.Results180 Cochrane reviews were included and from these, 773 primary studies were identified. Of these, 378 studies (n=38 368 participants) reported serious adverse events and 375 studies (n=38 517 participants) reported non-serious adverse events. We found no increase in risk of serious adverse events (RR=0.96 (95%CI 0.90 to 1.02, I2: 0.0%) due to exercise therapy. There was, however, an increase in non-serious adverse events (RR=1.19 (95%CI 1.09 to 1.30, I2: 0.0%). The number needed to treat for an additional harmful outcome for non-serious adverse events was 6 [95%CI 4 to 11).ConclusionParticipating in an exercise intervention increased the relative risk of non-serious adverse events, but not of serious adverse events. Exercise therapy may therefore be recommended as a relatively safe intervention.PROSPERO registration numberCRD42014014819.

scholarly journals Efficacy of non-opioid analgesics to control postoperative pain: a network meta-analysis

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
John A. Carter ◽  
Libby K. Black ◽  
Dolly Sharma ◽  
Tarun Bhagnani ◽  
Jonathan S. Jahr
Keyword(s):  
Postoperative Pain ◽  
Pain Intensity ◽  
Human Subjects ◽  
Meta Analysis ◽  
Opioid Analgesics ◽  
Abdominal Hysterectomy ◽  
Orthopedic Procedures ◽  
Intensity Difference ◽  
Cumulative Probability ◽  
Pain Intensity Difference

Abstract Background The aim of this network meta-analysis (NMA) was to evaluate the safety and efficacy of intravenous (IV) Meloxicam 30 mg (MIV), an investigational non-steroidal anti-inflammatory drug (NSAID), and certain other IV non-opioid analgesics for moderate-severe acute postoperative pain. Methods We searched PubMed and CENTRAL for Randomized Controlled Trials (RCT) (years 2000–2019, adult human subjects) of IV non-opioid analgesics (IV NSAIDs or IV Acetaminophen) used to treat acute pain after abdominal, hysterectomy, bunionectomy or orthopedic procedures. A Bayesian NMA was conducted in R to rank treatments based on the standardized mean differences in sum of pain intensity difference from baseline up to 24 h postoperatively (sum of pain intensity difference: SPID 24). The probability and the cumulative probability of rank for each treatment were calculated, and the surface under the cumulative ranking curve (SUCRA) was applied to distinguish treatments on the basis of their outcomes such that higher SUCRA values indicate better outcomes. The study protocol was prospectively registered with by PROSPERO (CRD42019117360). Results Out of 2313 screened studies, 27 studies with 36 comparative observations were included, producing a treatment network that included the four non-opioid IV pain medications of interest (MIV, ketorolac, acetaminophen, and ibuprofen). MIV was associated with the largest SPID 24 for all procedure categories and comparators. The SUCRA ranking table indicated that MIV had the highest probability for the most effective treatment for abdominal (89.5%), bunionectomy (100%), and hysterectomy (99.8%). MIV was associated with significantly less MME utilization versus all comparators for abdominal procedures, hysterectomy, and versus acetaminophen in orthopedic procedures. Elsewhere MME utilization outcomes for MIV were largely equivalent or nominally better than other comparators. Odds of ORADEs were significantly higher for all comparators vs MIV for orthopedic (gastrointestinal) and hysterectomy (respiratory). Conclusions MIV 30 mg may provide better pain reduction with similar or better safety compared to other approved IV non-opioid analgesics. Caution is warranted in interpreting these results as all comparisons involving MIV were indirect.

scholarly journals Effect ofKangfuxinSolution on Chemo/Radiotherapy-Induced Mucositis in Nasopharyngeal Carcinoma Patients: A Multicenter, Prospective Randomized Phase III Clinical Study

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Yangkun Luo ◽  
Mei Feng ◽  
Zixuan Fan ◽  
Xiaodong Zhu ◽  
Feng Jin ◽  
...  
Keyword(s):  
Clinical Study ◽  
Nasopharyngeal Carcinoma ◽  
Adverse Events ◽  
Oral Mucositis ◽  
Rating Scale ◽  
Test Group ◽  
Phase Iii ◽  
Control Group ◽  
Oral Pain ◽  
Gastrointestinal Mucositis

Objective. To evaluate the efficacy and safety ofKangfuxinSolution, a pure Chinese herbal medicine, on mucositis induced by chemoradiotherapy in nasopharyngeal carcinoma patients.Methods. A randomized, parallel-group, multicenter clinical study was performed. A total of 240 patients were randomized to receive eitherKangfuxinSolution (test group) or compound borax gargle (control group) during chemoradiotherapy. Oral mucositis, upper gastrointestinal mucositis, and oral pain were evaluated by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and the Verbal Rating Scale (VRS).Results. Of 240 patients enrolled, 215 were eligible for efficacy analysis. Compared with the control group, the incidence and severity of oral mucositis in the test group were significantly reduced (P=0.01). The time to different grade of oral mucositis occurrence (grade 1, 2, or 3) was longer in test group (P<0.01), and the accumulated radiation dose was also higher in test group comparing to the control group (P<0.05). The test group showed lower incidence of oral pain and gastrointestinal mucositis than the control group (P<0.01). No significant adverse events were observed.Conclusion.KangfuxinSolution demonstrated its superiority to compound borax gargle on mucositis induced by chemoradiotherapy. Its safety is acceptable for clinical application.

Acute Enterocolitis Incidence in Patients with Hematological Malignancies Receiving Myelotoxic Therapy Requiring Hematopoietic Stem Cell Support - Palifermin Experience.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5461-5461
Author(s):  
Isabel Sousa ◽  
Catarina Geraldes
Keyword(s):  
Stem Cell ◽  
Hematopoietic Stem Cell Transplantation ◽  
Adverse Events ◽  
Stem Cell Transplantation ◽  
Parenteral Nutrition ◽  
Hematopoietic Stem Cell ◽  
Oral Mucositis ◽  
Hematological Malignancies ◽  
Control Group ◽  
Hematopoietic Stem

Abstract Background: Chemotherapeutic agents can cause severe oral and gastrointestinal mucositis, for which there is currently no treatment. Previous research demonstrates that palifermin - keratinocyte growth factor - is potentially antimucotoxic, reducing the duration and severity of oral mucositis after intense chemotherapy in hematological cancers. The primary aim of this study was to determine palifermin effectiveness in ameliorating chemotherapy-induced diarrhoea and oral mucositis incidence. Palifermin adverse events were also assessed. Methods: Retrospective observational study involving patients with hematological malignancies undergoing autologous hematopoietic stem-cell transplantation after myelotoxic therapy. All the patients received antibiotic, antifungal, and antiviral prophylaxis. Patients being treated with palifermin to decrease the incidence and duration of severe oral mucositis (Palifermin Group) were compared to a control group of patients who did not receive palifermin (Control Group). Palifermin was administered during 3 consecutive days, before and after myelotoxic therapy in a 60 μg/Kg daily intravenous dose. Results: Twenty-four patients were included, 8 in Palifermin Group and 16 in Control Group. Baseline malignancies were Hodgkin and non Hodgkin lymphoma, acute myeloid leukemia, and multiple myeloma. All patients underwent autologous hematopoietic stem-cell transplantation after the following conditioning regimes: BEAM, BuCy, and Mel200 respectively. In Palifermin Group, 62.5% were male, mean age 47.6±13.0 years, mean disease duration of 22.3±10.1 months (N=8). In Control Group 56.3% were male, mean age 45.8±12.1 years (N=16). Mean performance status (Karnofsky Index) was 80±14.1% and 71.3±15.1%, in each group, respectively. No statistically significant differences between Palifermin and Control Groups were found regarding the degree of diarrhoea, although in the Palifermin Group the majority of patients presented a grade 2 (N=3) and in the Control Group a grade 3 (N=6). In the Palifermin Group there was a tendency for a lower incidence of hypoalbuminemia [12.5% (Palifermin Group) vs. 50% (Control Group)], which corresponded to a significant lower difference in the needs for receiving parenteral nutrition (P=0.011). Nevertheless, these findings were not translated in less febrile episodes or less iv antibiotic therapy days. There were no significant differences between the two groups regarding the degree of oral mucositis, the number of days of analgesic opioids use, and the number of hospitalization days, most probably due to the small sample considered. The most common adverse events in the Palifermin Group were reversible erythema and edema of the face and upper trunk that have occurred only in 3 patients. Weight increase was mild and similar in both groups of patients [Median weight increase±SD: 1,0±1,7 Kg (Palifermin Group) vs 2,0±2,5 Kg (Control group)]. Conclusion: Gastrointestinal and oral mucositis are common consequences of cancer therapy with a direct and significant impact on the quality of life and care costs, also affecting patient’s survival. Our exploratory study shows that palifermin treatment is well tolerated, potentially reducing diarrhoea and the incidence of hypoalbuminemia, and significantly reducing the needs for parenteral nutrition. However further studies with an increased number of patients will be necessary to provide more evidence concerning palifermin efficacy in the management of these cancer therapy’s debilitating side-effects.

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