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The effect of comprehensive oral care program on oral health and quality of life in patients undergoing radiotherapy for head and neck cancer: A quasi-experimental case-control study.
Lee, HJ, Han, DH, Kim, JH, Wu, HG
Medicine. 2021;(16):e25540
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Abstract
OBJECTIVES The purpose of this study is to investigate the effect of the comprehensive oral care program on oral health status and symptoms in head and neck cancer (HNC) patients undergoing radiotherapy. METHODS This was a quasi-experimental study using a non-equivalent control group in non-synchronized design. All participants including control and experimental group were asked for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire H&N35 (EORTC QLQ-H&N35) and given an oral health education 4 times at baseline, immediate postradiotherapy, 3 months after radiotherapy, and 6 months after radiotherapy. In each visit except for final, the experimental group was given fluoride varnish application and fluoride mouth rinsing solution for daily use. Oral health examination for dental caries, plaque score (PS), bleeding on probing (BOP), and salivary flow rate was performed in baseline and 6 months after radiotherapy. Statistical analyses were done by paired t-tests and mixed ANCOVA repeated-measures analysis. RESULTS From November 1, 2013 to October 31, 2015, a total 61 patients undergoing radiotherapy for HNC cancer were enrolled (30 in control and 31 in experimental groups). Decrease in salivary flow rate was comparable between 2 groups. Dental caries increased in control group (P = .006); PS and BOP were decreased in experimental group (P < .001 and .004, respectively). Experimental group showed lower swallowing, speech problems, and less sexuality scores in EORTC QLQ-H&N35 than control group. CONCLUSION We found improvement in oral health and the quality of life in HNC patients with comprehensive oral care intervention by dental professionals. Communicating and cooperating between the healthcare and dental professionals is needed to raise the quality of health care services for HNC patients receiving radiotherapy.
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Randomized, double-blind, placebo-controlled phase II trial of nanocurcumin in prostate cancer patients undergoing radiotherapy.
Saadipoor, A, Razzaghdoust, A, Simforoosh, N, Mahdavi, A, Bakhshandeh, M, Moghadam, M, Abdollahi, H, Mofid, B
Phytotherapy research : PTR. 2019;(2):370-378
Abstract
Clinical potential of curcumin in radiotherapy (RT) setting is outstanding and of high interest. The main purpose of this randomized controlled trial (RCT) was to assess the beneficial role of nanocurcumin to prevent and/or mitigate radiation-induced proctitis in prostate cancer patients undergoing RT. In this parallel-group study, 64 eligible patients with prostate cancer were randomized to receive either oral nanocurcumin (120 mg/day) or placebo 3 days before and during the RT course. Acute toxicities including proctitis and cystitis were assessed weekly during the treatment and once thereafter using CTCAE v.4.03 grading criteria. Baseline-adjusted hematologic nadirs were also analyzed and compared between the two groups. The patients undergoing definitive RT were followed to evaluate the tumor response. Nanocurcumin was well tolerated. Radiation-induced proctitis was noted in 18/31 (58.1%) of the placebo-treated patients versus 15/33 (45.5%) of nanocurcumin-treated patients (p = 0.313). No significant difference was also found between the two groups with regard to radiation-induced cystitis, duration of radiation toxicities, hematologic nadirs, and tumor response. In conclusion, this RCT was underpowered to indicate the efficacy of nanocurcumin in this clinical setting but could provide a considerable new translational insight to bridge the gap between the laboratory and clinical practice.
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11C-methionine-PET for differentiating recurrent brain tumor from radiation necrosis: radiomics approach with random forest classifier.
Hotta, M, Minamimoto, R, Miwa, K
Scientific reports. 2019;(1):15666
Abstract
Differentiating recurrent brain tumor from radiation necrosis is often difficult. This study aims to investigate the efficacy of 11C-methionine (MET)-PET radiomics for distinguishing recurrent brain tumor from radiation necrosis, as compared with conventional tumor-to-normal cortex (T/N) ratio evaluation. We enrolled 41 patients with metastatic brain tumor or glioma treated using radiation therapy who underwent MET-PET. The area with a standardized uptake value > 1.3 times that of the normal brain cortex was contoured. Forty-two PET features were extracted and used in a random forest classifier and the diagnostic performance was evaluated using a 10-fold cross-validation scheme. Gini index was measured to identify relevant PET parameters for classification. The reference standard was surgical histopathological analysis or more than 6 months of follow-up with MRI. Forty-four lesions were used for the analysis. Thirty-three and 11 lesions were confirmed as recurrent brain tumor and radiation necrosis, respectively. Radiomics and T/N ratio evaluation showed sensitivities of 90.1% and 60.6%, and specificities of 93.9% and 72.7% with areas under the curve of 0.98 and 0.73, respectively. Gray level co-occurrence matrix dissimilarity was the most pertinent feature for diagnosis. MET-PET radiomics yielded excellent outcome for differentiating recurrent brain tumor from radiation necrosis, which outperformed T/N ratio evaluation.
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Safety and Efficacy of Mesenchymal Stem Cells for Radiation-Induced Xerostomia: A Randomized, Placebo-Controlled Phase 1/2 Trial (MESRIX).
Grønhøj, C, Jensen, DH, Vester-Glowinski, P, Jensen, SB, Bardow, A, Oliveri, RS, Fog, LM, Specht, L, Thomsen, C, Darkner, S, et al
International journal of radiation oncology, biology, physics. 2018;(3):581-592
Abstract
BACKGROUND Salivary gland hypofunction and xerostomia are major complications to head and neck radiotherapy. This trial assessed the safety and efficacy of adipose tissue-derived mesenchymal stem cell (ASC) therapy for radiation-induced xerostomia. PATIENT AND METHODS This randomized, placebo-controlled phase 1/2 trial included 30 patients, randomized in a 1:1 ratio to receive ultrasound-guided transplantation of ASCs or placebo to the submandibular glands. Patients had previously received radiotherapy for a T1-2, N0-2A, human papillomavirus-positive, oropharyngeal squamous cell carcinoma. The primary outcome was the change in unstimulated whole salivary flow rate, measured before and after the intervention. All assessments were performed one month prior (baseline) and one and four months following ASC or placebo administration. RESULTS No adverse events were detected. Unstimulated whole salivary flow rates significantly increased in the ASC-arm at one (33%; P = .048) and four months (50%; P = .003), but not in the placebo-arm (P = .6 and P = .8), compared to baseline. The ASC-arm symptom scores significantly decreased on the xerostomia and VAS questionnaires, in the domains of thirst (-22%, P = .035) and difficulties in eating solid foods (-2%, P = .008) after four months compared to baseline. The ASC-arm showed significantly improved salivary gland functions of inorganic element secretion and absorption, at baseline and four months, compared to the placebo-arm. Core-needle biopsies showed increases in serous gland tissue and decreases in adipose and connective tissues in the ASC-arm compared to the placebo-arm (P = .04 and P = .02, respectively). MRIs showed no significant differences between groups in gland size or intensity (P < .05). CONCLUSIONS ASC therapy for radiation-induced hypofunction and xerostomia was safe and significantly improved salivary gland functions and patient-reported outcomes. These results should encourage further exploratory and confirmatory trials.
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Effects of a dietary intervention on gastrointestinal symptoms after prostate cancer radiotherapy: long-term results from a randomized controlled trial.
Pettersson, A, Nygren, P, Persson, C, Berglund, A, Turesson, I, Johansson, B
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. 2014;(2):240-7
Abstract
BACKGROUND AND PURPOSE To evaluate the long-term effects of dietary intervention on gastrointestinal symptoms after highly dose-escalated radiotherapy for localized prostate cancer, using boost with protons or high-dose-rate brachytherapy. MATERIALS AND METHODS Patients were randomized to an intervention group (n=64) advised to reduce insoluble dietary fiber and lactose intake, or to a standard care group (n=66) advised to continue their usual diet. Gastrointestinal symptoms, other domains of health-related quality of life (HRQOL), and dietary intake were evaluated for ⩽24months post-radiotherapy with the European Organization for Research and Treatment of Cancer quality-of-life questionnaires QLQ-C30 and QLQ-PR25, Gastrointestinal Side Effects Questionnaire, and Food Frequency Questionnaire. The effect of the intervention on gastrointestinal symptoms was evaluated using generalized estimating equations. RESULTS Dietary intervention had no obvious effect on long-term gastrointestinal symptoms or HRQOL. The intervention group markedly reduced their dietary fiber and lactose intake during radiotherapy, but adherence tended to decline over time. The vast majority of long-term gastrointestinal symptoms were reported as 'a little', with a noticeable difference from pre-treatment only for unintentional stool leakage, limitations on daily activities, and mucus discharge. CONCLUSION Long-term gastrointestinal symptoms were predominantly mild, and dietary intervention was not superior to a usual diet in preventing these symptoms.
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Adaptive/nonadaptive proton radiation planning and outcomes in a phase II trial for locally advanced non-small cell lung cancer.
Koay, EJ, Lege, D, Mohan, R, Komaki, R, Cox, JD, Chang, JY
International journal of radiation oncology, biology, physics. 2012;(5):1093-100
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Abstract
PURPOSE To analyze dosimetric variables and outcomes after adaptive replanning of radiation therapy during concurrent high-dose protons and chemotherapy for locally advanced non-small cell lung cancer (NSCLC). METHODS AND MATERIALS Nine of 44 patients with stage III NSCLC in a prospective phase II trial of concurrent paclitaxel/carboplatin with proton radiation [74 Gy(RBE) in 37 fractions] had modifications to their original treatment plans after re-evaluation revealed changes that would compromise coverage of the target volume or violate dose constraints; plans for the other 35 patients were not changed. We compared patients with adaptive plans with those with nonadaptive plans in terms of dosimetry and outcomes. RESULTS At a median follow-up of 21.2 months (median overall survival, 29.6 months), no differences were found in local, regional, or distant failure or overall survival between groups. Adaptive planning was used more often for large tumors that shrank to a greater extent (median, 107.1 cm(3) adaptive and 86.4 cm(3) nonadaptive; median changes in volume, 25.3% adaptive and 1.2% nonadaptive; P<.01). The median number of fractions delivered using adaptive planning was 13 (range, 4-22). Adaptive planning generally improved sparing of the esophagus (median absolute decrease in V(70), 1.8%; range, 0%-22.9%) and spinal cord (median absolute change in maximum dose, 3.7 Gy; range, 0-13.8 Gy). Without adaptive replanning, target coverage would have been compromised in 2 cases (57% and 82% coverage without adaptation vs 100% for both with adaptation); neither patient experienced local failure. Radiation-related grade 3 toxicity rates were similar between groups. CONCLUSIONS Adaptive planning can reduce normal tissue doses and prevent target misses, particularly for patients with large tumors that shrink substantially during therapy. Adaptive plans seem to have acceptable toxicity and achieve similar local, regional, and distant control and overall survival, even in patients with larger tumors, vs nonadaptive plans.
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Long-term results of an RTOG Phase II trial (00-19) of external-beam radiation therapy combined with permanent source brachytherapy for intermediate-risk clinically localized adenocarcinoma of the prostate.
Lawton, CA, Yan, Y, Lee, WR, Gillin, M, Firat, S, Baikadi, M, Crook, J, Kuettel, M, Morton, G, Sandler, H
International journal of radiation oncology, biology, physics. 2012;(5):e795-801
Abstract
PURPOSE External-beam radiation therapy combined with low-doserate permanent brachytherapy are commonly used to treat men with localized prostate cancer. This Phase II trial was performed to document late gastrointestinal or genitourinary toxicity as well as biochemical control for this treatment in a multi-institutional cooperative group setting. This report defines the long-term results of this trial. METHODS AND MATERIALS All eligible patients received external-beam radiation (45 Gy in 25 fractions) followed 2-6 weeks later by a permanent iodine 125 implant of 108 Gy. Late toxicity was defined by the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme. Biochemical control was defined by the American Society for Therapeutic Radiology and Oncology (ASTRO) Consensus definition and the ASTRO Phoenix definition. RESULTS One hundred thirty-eight patients were enrolled from 20 institutions, and 131 were eligible. Median follow-up (living patients) was 8.2 years (range, 2.7-9.3 years). The 8-year estimate of late grade >3 genitourinary and/or gastrointestinal toxicity was 15%. The most common grade >3 toxicities were urinary frequency, dysuria, and proctitis. There were two grade 4 toxicities, both bladder necrosis, and no grade 5 toxicities. In addition, 42% of patients complained of grade 3 impotence (no erections) at 8 years. The 8-year estimate of biochemical failure was 18% and 21% by the Phoenix and ASTRO consensus definitions, respectively. CONCLUSION Biochemical control for this treatment seems durable with 8 years of follow-up and is similar to high-dose external beam radiation alone or brachytherapy alone. Late toxicity in this multi-institutional trial is higher than reports from similar cohorts of patients treated with high-dose external-beam radiation alone or permanent low-doserate brachytherapy alone, perhaps suggesting further attention to strategies that limit doses to normal structures or to unimodal radiotherapy techniques.
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A prospective investigation of swallowing, nutrition, and patient-rated functional impact following altered fractionation radiotherapy with concomitant boost for oropharyngeal cancer.
Cartmill, B, Cornwell, P, Ward, E, Davidson, W, Porceddu, S
Dysphagia. 2012;(1):32-45
Abstract
Altered fractionation radiotherapy for head and neck cancer has been associated with improved locoregional control, overall survival, and heightened toxicity compared with conventional treatment. Swallowing, nutrition, and patient-perceived function for altered fractionation radiotherapy with concomitant boost (AFRT-CB) for T1-T3 oropharyngeal squamous cell carcinoma (SCC) have not been previously reported. Fourteen consecutive patients treated with AFRT-CB for oropharyngeal SCC were recruited from November 2006 to August 2009 in a tertiary hospital in Brisbane, Australia. Swallowing, nutrition, and patient-perceived functional impact assessments were conducted pretreatment, at 4-6 weeks post-treatment, and at 6 months post-treatment. Deterioration from pretreatment to 4-6 weeks post-treatment in swallowing, nutrition, and functional impact was evident, likely due to the heightened toxicity associated with AFRT-CB. There was significant improvement at 6 months post-treatment in functional swallowing, nutritional status, patient-perceived swallowing, and overall function, consistent with recovery from acute toxicity. However, weight and patient perception of physical function and side effects remained significantly worse than pretreatment scores. The ongoing deficits related to weight and patient-perceived outcomes at 6 months revealed that this treatment has a long-term impact on function possibly related to the chronic effects of AFRT-CB.
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Acute and late toxicity after dose escalation to 82 GyE using conformal proton radiation for localized prostate cancer: initial report of American College of Radiology Phase II study 03-12.
Coen, JJ, Bae, K, Zietman, AL, Patel, B, Shipley, WU, Slater, JD, Rossi, CJ
International journal of radiation oncology, biology, physics. 2011;(4):1005-9
Abstract
PURPOSE Several randomized trials have shown a benefit of dose escalation to 78 to 79 Gy for men treated with external radiation for localized prostate cancer. Single-institution data suggest a benefit with even higher doses. American College of Radiology 03-12 is a Phase II trial testing the safety and efficacy of 82 GyE (Gray equivalent) delivered with conformal proton radiation. METHODS AND MATERIALS From 2003-2006, 85 men with localized prostate cancer were accrued to American College of Radiology 03-12. Eighty-four were eligible for analysis. They were treated with conformal proton radiation alone to a total dose of 82 GyE. The study was designed to test whether the rate of 18-month Grade 3+ late toxicity was greater than 10%. RESULTS The median follow-up was 31.6 months. Regarding treatment-related acute toxicity, there were 39 Grade 1 cases (46%), 19 Grade 2 cases (23%) and 2 Grade 3 cases (2%). Regarding genitourinary/gastrointestinal toxicity, there were 42 Grade 1 cases (50%), 12 Grade 2 cases (14%) and 1 Grade 3 case (1%). Regarding late toxicity, there were 28 Grade 1 cases (33%), 22 Grade 2 cases (26%), 6 Grade 3 cases (7%), and 1 Grade 4 case (1%). The late genitourinary/gastrointestinal rates were the same. The estimated rate of Grade 3+ late toxicity at 18 months was 6.08%. CONCLUSIONS Although not free of late toxicity, 82 GyE at 2 GyE per fraction delivered with conformal proton radiation did not exceed the late morbidity target tested in this trial. There was sufficient morbidity, however, that this may be the maximal dose that can be delivered safely with this technique and fractionation.
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Longitudinal analysis of genitourinary and bowel symptoms in prostate cancer patients following brachytherapy.
Eckman, MH, Ying, J, Hertzfeld, K, Kumar, N, Barrett, W
American journal of clinical oncology. 2010;(1):1-10
Abstract
OBJECTIVES Multiple options with similar cure rates exist for men with localized adenocarcinoma of the prostate. Therefore, treatment-related morbidity is a major consideration for treatment selection. We present a descriptive, longitudinal analysis of genitourinary and bowel symptoms following treatment in a brachytherapy registry at the University of Cincinnati. METHODS Between 1995 and 2007, 394 consecutive patients with newly diagnosed early stage prostate cancer underwent radioactive (125)I seed implantation. Patients were followed for an average of 5.0 +/- 3.1 years. Follow-up data regarding genitourinary and bowel symptoms and clinical/biochemical evidence of cancer recurrence were collected during posttreatment visits. RESULTS Forty percent of men developed urinary obstructive symptoms, generally within the first 3 to 6 months following brachytherapy. These symptoms resolved in a large proportion of men. Impaired potency occurred in 15% of men by 6 months and in more than 40% of men by 60 months. Bowel symptoms were less common and had a slower onset. CONCLUSION Symptoms following brachytherapy each have their own temporal pattern for development and resolution. These patterns are well explained by the underlying pathophysiology of therapeutic radiation injury and healing. Men and their partners can use this information to guide and inform treatment decisions.