***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: PURPOSE To investigate the impact of xerostomia on overall quality of life ( QoL ) outcome and related dimensions among head and neck cancer patients treated with primary radiotherapy .  METHODS AND MATERIAL S A total of 288 patients with Stage I-IV disease without distant metastases were included .  Late xerostomia according to the Radiation Therapy Oncology Group ( RTOG-xerostomia ) and QoL ( European Organization for Research and Treatment of Cancer QLC-C30 ) were assessed at baseline and every 6th month from 6 months to 24 months after radiotherapy . RESULTS A significant association was found between RTOG-xerostomia and overall QoL outcome ( effect size [ ES ] 0.07 , p < 0.001 ) . A significant relationship with global QoL , all functioning scales , and fatigue and insomnia was observed . A significant interaction term was present between RTOG-xerostomia and gender and between RTOG-xerostomia and age . In terms of gender , RTOG-xerostomia had a larger impact on overall QoL outcome in women ( ES 0.13 for women vs. 0.07 for men ) . Furthermore , in women ES on individual scales were larger , and a marked worsening was observed with increasing RTOG-xerostomia . No different ES according to age was seen ( ES 0.10 for 18 - 65 years vs. 0.08 for > 65 years ) . An analysis of the impact of RTOG-xerostomia on overall QoL outcome over time showed an increase from 0.09 at 6 months to 0.22 at 24 months . With elapsing time , a worsening was found for these individual scales with increasing RTOG-xerostomia . CONCLUSIONS The results of this prospect i ve study are the first to show a significant impact of radiation-induced xerostomia on QoL. Although the incidence of Grade > or = 2 RTOG-xerostomia decreases with time , its impact on QoL increases . This finding emphasizes the importance of prevention of xerostomia PURPOSE To evaluate chronic xerostomia and tumor control 18 and 24 months after initial treatment with amifostine in a r and omized controlled trial of patients with head- and -neck cancer ; at 12 months after radiotherapy ( RT ) , amifostine had been shown to reduce xerostomia without changing tumor control . METHODS AND MATERIAL S Adults with head- and -neck cancer who underwent once-daily RT for 5 - 7 weeks ( total dose , 50 - 70 Gy ) received either  open-label amifostine ( 200 mg/m2 i.v . ) 15 - 30 min before each fraction of radiation ( n = 150 ) or RT alone ( control ; n = 153 ) . RESULTS Amifostine administration was associated with a reduced incidence of Grade > or = 2 xerostomia over 2 years of follow-up ( p = 0.002 ) , an increase in the proportion of patients with meaningful ( > 0.1 g ) unstimulated saliva production at 24 months ( p = 0.011 ) , and reduced mouth dryness scores on a patient benefit question naire at 24 months ( p < 0.001 ) . Locoregional control rate , progression-free survival , and overall survival were not significantly different between the amifostine group and the control group . CONCLUSIONS Amifostine administration during head- and -neck RT reduces the severity and duration of xerostomia 2 years after treatment and does not seem to compromise locoregional control rates , progression-free survival , or overall survival Background . Salivary gl and hypofunction commonly develops during radiation therapy to the head and neck region . This study evaluated whether the sialogogue pilocarpine given during radiation therapy may reduce the severity of xerostomia and salivary dysfunction PURPOSE To assess long-term xerostomia in patients receiving parotid-sparing radiation therapy ( RT ) for head- and -neck cancer , and to find the patient and therapy-related factors that affect its severity . PATIENTS AND METHODS From March 1994 through January 2000 , 84 patients received comprehensive bilateral neck RT using conformal and multisegmental intensity-modulated RT ( IMRT )  aim ing to spare the major salivary gl and s. Before RT and periodically through 2 years after the completion of RT , salivary flow rates from each of the major salivary gl and s were selectively measured . At the same time intervals , each patient completed an 8-item self-reported xerostomia-specific question naire ( XQ ) . To gain a relative measure of the effect of RT on the minor salivary gl and s , whose output could not be measured , the surfaces of the oral cavity ( extending to include the surface of the base of tongue ) were outlined in the planning CT scans . The mean doses to the new organ ( " oral cavity " ) were recorded . Forty-eight patients receiving unilateral neck RT  were similarly studied and served as a benchmark for comparison . Factors predicting the XQ scores were analyzed using a r and om-effects model . RESULTS The XQ was found to be reliable and valid in measuring patient-reported xerostomia . The spared salivary gl and s which had received moderate doses in the bilateral RT group recovered to their baseline salivary flow rates during the second year after RT , and the spared gl and s in the unilateral RT group , which had received very low doses , demonstrated increased salivary production beyond their pre-RT levels . The increase in the salivary flow rates during the second year after RT paralleled an improvement in xerostomia in both patient groups . The improvement in xerostomia was faster in the unilateral compared with the bilateral RT group , but the difference narrowed at 2 years . The major salivary gl and flow rates had only a weak correlation with the xerostomia scores . Factors found to be independently associated with the xerostomia scores were the pre-RT baseline scores , the time since RT , and the mean doses to the major salivary gl and s ( notably to the subm and ibular gl and s ) and to the oral cavity . CONCLUSION An improvement over time in xerostomia , occurring in t and em with rising salivary production from the spared major salivary gl and s , suggests a long-term clinical benefit from their sparing . The oral cavity mean dose , representing RT effect on the minor salivary gl and s , was found to be a significant , independent predictor of xerostomia . Thus , in addition to the major salivary gl and s , sparing the uninvolved oral cavity should be considered as a planning objective to further reduce xerostomia BACKGROUND This prospect i ve r and omized study was undertaken to assess the effectiveness of oral pilocarpine chloratum ( Salagen ) during and after radiotherapy . PATIENTS AND METHODS Between October 1999 and December 2003 , 66 patients received 60 Gy of irradiation to their head and neck cancer . Half of the patients received 5 mg oral pilocarpine 3 times a day from the beginning of radiotherapy over a period of 12 weeks . The control group received similar doses of pilocarpine only in the second 6 weeks following irradiation . Patient saliva secretion was recorded , and a visual analog scale measuring overall and daily xerostomia , difficulty in sleeping , speaking , eating and wearing dentures was employed . RESULTS Pilocarpine , given concomitantly with radiotherapy , statistically improved the salivary flow and induced better patient comfort by the end of radiotherapy . Patient comfort and symptoms related to xerostomia greatly decreased compared to patients receiving pilocarpine after irradiation in the second 6-week period of therapy . The patients ' quality of life , saliva production and symptoms related to xerostomia showed significant progress by the end of the 12 weeks . CONCLUSION The results suggest that stimulated salivary gl and s suffer less decrease in saliva production during radiotherapy . The stimulated saliva flow reduced the side-effects of irradiation PURPOSE To investigate the effect of concomitant administration of pilocarpine during radiotherapy for head- and -neck squamous cell carcinoma ( HNSCC ) on postradiotherapy xerostomia . METHODS AND MATERIAL S A prospect i ve , double blind , placebo-controlled r and omized trial including 170 patients with HNSCC was executed to study the protective effect of pilocarpine on radiotherapy-induced parotid gl and dysfunction . The primary objective endpoint was parotid flow rate complication probability ( PFCP ) scored 6 weeks , 6 months , and 12 months after radiotherapy . Secondary endpoints included Late Effects of Normal Tissue/Somatic Objective Management Analytic scale ( LENT SOMA ) and patient-rated xerostomia scores . For all parotid gl and s , dose-volume histograms were assessed because the dose distribution in the parotid gl and s is considered the most important prognostic factor with regard to radiation-induced salivary dysfunction . RESULTS Although no significant differences in PFCP were found for the two treatments arms , a significant ( p = 0.03 ) reduced loss of parotid flow 1 year after radiotherapy was observed in those patients who received pilocarpine and a mean parotid dose above 40 Gy . The LENT SOMA and patient-rated xerostomia scores showed similar trends toward less dryness-related complaints for the pilocarpine group . CONCLUSIONS Concomitant administration of pilocarpine during radiotherapy did not improve the PFCP or LENT SOMA and patient-rated xerostomia scores . In a subgroup of patients with a mean dose above 40 Gy , pilocarpine administration result ed in sparing of parotid gl and function . Therefore , pilocarpine could be provided to patients in whom sufficient sparing of the parotid is not achievable PURPOSE To test the hypothesis that the use of oral pilocarpine during and after radiotherapy ( RT ) for head- and -neck cancer would reduce the symptoms of post-RT xerostomia . METHODS AND MATERIAL S One hundred thirty patients were r and omized in a double-blind method to receive either pilocarpine ( 5-mg tablets ) or placebo three times daily starting on Day 1 of RT and continuing for 1 month after treatment . The eligibility criteria included a planned dose of > 50 Gy as radical or postoperative RT for head- and -neck cancer , with at least 50 % of both parotid gl and s included in the treatment fields . The primary outcome measure was the severity of xerostomia as assessed by a patient-completed linear analog scale 3 months after RT . Secondary outcome measures included quality of life during therapy ( as assessed by the McMaster University Head- and -Neck Question naire ) and severity of mucositis during RT ( as assessed using Radiation Therapy Oncology Group scales ) . RESULTS No difference was observed between the pilocarpine-treated patients and the placebo group in the severity of xerostomia score as assessed by linear analog scale at baseline and 1 , 3 , and 6 months after treatment ( repeated measures analysis , p = 0.92 ) . No difference was apparent in the severity of mucositis during RT ; 56.3 % of patients receiving pilocarpine had Grade III/IV mucositis compared with 50.8 % treated with placebo . No difference in quality of life was noted between the treatment groups during or after RT . The question naire score at 3 months after RT was 5.0 ( SD 1.0 ) . in the pilocarpine group and 4.9 ( SD 0.9 ) in the placebo group . CONCLUSION We were unable to detect a beneficial effect of pilocarpine on RT-induced xerostomia when administered during RT for head- and -neck cancer Radiation therapy is an important curative modality in the treatment of patients with head and neck cancer . However , radiation-induced changes in the oral cavity , such as xerostomia and mucositis , are among the most debilitating treatment sequelae experienced by patients undergoing radiation therapy  , and attempts at ameliorating these side effects have been poor at best . Pilocarpine has been approved for post-radiation xerostomia , and the effect of its use during radiation therapy on salivary flow , xerostomia , mucositis , and quality of life ( QOL ) was assessed in a phase III study conducted by the Radiation Therapy Oncology Group ( RTOG 97 - 09 ) . In total , 245 evaluable patients were r and omized to pilocarpine or placebo . Selected patients were required to have > or = 50 % of the volume of the major salivary gl and s receive > or = 50Gy ; to agree to provide stimulated and unstimulated sample s of saliva ( measured in g ) before treatment , at the end of treatment , and 3 and 6 months after completion of radiation therapy ; and to complete the University of Washington Head and Neck Symptom Scale . Following the completion of radiation therapy , the average unstimulated salivary flow was statistically greater in the pilocarpine group , whereas no difference was noted following parotid stimulation . There was no effect on the amelioration of mucositis . The results of the QOL scales did not reveal any significant difference between the pilocarpine and placebo groups with regard to xerostomia and mucositis . The significant difference in unstimulated salivary flow supports the concomitant use of oral pilocarpine to decrease radiation-associated xerostomia . However , the absent correlation between improved salivary flow and QOL scores is of some concern ( though not a new finding ) and may be related to the existence of comorbidities and the lack of effect on 
    Output:
    
Concomitant administration of pilocarpine during radiation could increase the unstimulated salivary flow rate in a period of 3 to 6 months after treatment , and also reduce the clinician-rated xerostomia grade .
Patient-reported xerostomia was not significantly impacted by pilocarpine in the initial 3 months but was superior at 6 months .
No significant difference of stimulated salivary flow rate could be confirmed between the 2 arms .
Adverse effects of pilocarpine were mild and tolerable .
CONCLUSIONS The concomitant administration of pilocarpine during radiation increases unstimulated salivary flow rate and reduces clinician-rated xerostomia grade after radiation .
It also relieves patients ' xerostomia at 6 months and possibly at 12 months .
However , pilocarpine has no effect on stimulated salivary flow rate