Efficacy of exercise therapy during radiotherapy to prevent reduction in mouth opening in patients with head and neck cancer: A randomized controlled trial.

OBJECTIVE: The aim of this study was to compare the efficacy of 2 protocols of exercise therapy to avoid reduction in mouth opening (MO) in patients undergoing radiotherapy for head and neck cancer. STUDY DESIGN: This was a randomized, controlled, double-blind, 3-arm, parallel-group, prevention clinical trial. Ninety patients were randomized into 3 groups to perform exercises during radiotherapy treatment: intervention group 1 (G1); intervention group 2 (G2); and control group (CG). Maximum MO was measured before (T0), immediately after (T1), and at 12 months (T2) after completion of radiotherapy treatment. Generalized estimating equations model complemented by the least significant difference test was applied to group comparisons. RESULTS: There was no significant difference in MO measure between the groups at the 3 assessment time points (P = .264). The difference in MO measure from baseline to 12 months after having completed radiotherapy was -1 mm in CG (95% confidence interval [CI] -4.0 to 2.0); 1.3 mm in G1 (95% CI -1.7 to 4.3); and 0.5 mm in G2 (95% CI -3.4 to 4.4). CONCLUSIONS: It was not possible to conclude that the exercise protocols performed in this study are more effective than the usual guidance to prevent reduction in MO in patients undergoing radiotherapy for head and neck cancer.

Hypofractionated radiotherapy for complicated bone metastases in patients with poor performance status: a phase II international trial.

PURPOSE: To evaluate the efficacy and safety of hypofractionated radiotherapy (16 Gy in 2 fractions, 1 week apart) in patients with complicated bone metastases and poor performance status. METHODS: A prospective single-arm phase II clinical trial was conducted from July 2014 to May 2016. The primary endpoint was pain response as defined in the International Consensus on Palliative Radiotherapy Endpoints. Secondary endpoints included quality of life as measured by quality of life questionnaire (QLQ) PAL-15 and QLQ-BM22 European Organisation for Research and Treatment of Cancer guidelines, pain flare, adverse events, re-irradiation, and skeletal complications. RESULTS: Fifty patients were enrolled. There were 23 men with a median age of 58 years (range 26-86). Of the 50 patients, 38 had an extraosseous soft tissue component, 18 needed postsurgical radiation, 3 had neuropathic pain, and 3 had an impending fracture in a weight-bearing bone. At 2 months, 33 patients were alive (66%). Four (12.5%) had a complete response and 12 (37.5%) had a partial response. A statistically significant improvement was seen in the functional interference (p = 0.01) and psychosocial aspects (p = 0.03) of the BM22. No patient had spinal cord compression. One patient required surgery for pathologic fracture, and another re-irradiation. CONCLUSIONS: Hypofractionated radiotherapy (16 Gy in 2 fractions of 8 Gy 1 week apart) achieved satisfactory pain relief and safety results in patients with complicated bone metastases and poor performance status.

Jaw mobility changes in patients with upper aerodigestive tract cancer undergoing radiation therapy

BACKGROUND: Radiation therapy is a therapeutic modality widely used for treatment of upper aerodigestive tract (UADT) neoplasms. However, its action is not restricted to tumor cells, and it may cause a variety of adverse reactions, including reduced jaw mobility. MATERIAL AND METHODS: A prospective cohort study was conducted to assess changes in jaw mobility in patients with UADT cancer undergoing radiation therapy. RESULTS: Fifty-six patients completed the study. The results showed a significant reduction in mouth opening (p < 0.001), right lateral excursion (p = 0.038) and left lateral excursion (p = 0.035) of the jaw, a significant increase in the presence (p < 0.001) and severity of oral mucositis (p < 0.001), and a significant decrease in performance status (p < 0.001) after radiation therapy. Thirty-six patients (64.3%) exhibited reduction in mouth opening after treatment. The variables significantly associated with mouth opening reduction on bivariate analysis were: modification of diet (p = 0.037), radiation field (p = 0.024), presence of mucositis (p = 0.003), and reduction in performance status (p = 0.007). After adjustment by the multivariate model, the only variables that remained significantly associated with reduction in mouth opening were presence of mucositis (p = 0.018) and reduction in performance status (p = 0.47). CONCLUSIONS: These findings indicate that patients with upper aerodigestive tract cancer experience reduced jaw mobility after radiation therapy, which is strongly correlated with mucositis and reduced functional ability

Jaw mobility changes in patients with upper aerodigestive tract cancer undergoing radiation therapy.

BACKGROUND: Radiation therapy is a therapeutic modality widely used for treatment of upper aerodigestive tract (UADT) neoplasms. However, its action is not restricted to tumor cells, and it may cause a variety of adverse reactions, including reduced jaw mobility. MATERIAL AND METHODS: A prospective cohort study was conducted to assess changes in jaw mobility in patients with UADT cancer undergoing radiation therapy. RESULTS: Fifty-six patients completed the study. The results showed a significant reduction in mouth opening (p<0.001), right lateral excursion (p=0.038) and left lateral excursion (p=0.035) of the jaw, a significant increase in the presence (p<0.001) and severity of oral mucositis (p<0.001), and a significant decrease in performance status (p<0.001) after radiation therapy. Thirty-six patients (64.3%) exhibited reduction in mouth opening after treatment. The variables significantly associated with mouth opening reduction on bivariate analysis were: modification of diet (p=0.037), radiation field (p=0.024), presence of mucositis (p=0.003), and reduction in performance status (p=0.007). After adjustment by the multivariate model, the only variables that remained significantly associated with reduction in mouth opening were presence of mucositis (p=0.018) and reduction in performance status (p=0.47). CONCLUSIONS: These findings indicate that patients with upper aerodigestive tract cancer experience reduced jaw mobility after radiation therapy, which is strongly correlated with mucositis and reduced functional ability.

Evaluation of acute radiation effects on mandibular movements of patients with head and neck cancer.

OBJECTIVES: To evaluate radiotherapy effects (RT) on mandibular movements of patients with head and neck cancer (H&NC) and associate them to the variables: functional capacity, radiation field, disease staging, type of feeding, concomitant chemotherapy and total dose of RT. METHODS: Twenty-six patients with H&NC were followed up at the RT service. Physical examination was performed in 3 follow up time points: before the beginning of RT (T0), between 14th and 17th session of RT (T1) and after the last session of RT (T2). The physical examination consisted of the assessment of the following variables: mouth opening without pain (MO), maximum mouth opening (MMO), right lateral excursion (RLE), left lateral excursion (LLE) and protrusion (PR) of the jaw. The feeding type and the Karnofsky Performance Status Scale (KPS) were evaluated in each follow up time point. Data with regards to the tumor lesion and the RT were collected from the patient's clinical notes. RESULTS: There was a statistical significant reduction in the values of MO (p=0.006), MMO (p=0.001), LLE (p=0.006) and KPS (p=0.001). There was significant a statistical association among the reduction in KPS and decreased measure of MO (r=0.390, p=0.048) and MMO (r=0.435, p=0.026). The mouth and oropharynx radiation fields when combined showed a significant reduction for both the measure of MO (p=0.005) and for MMO (p=0.004). Patients who used nasoenteric tube feeding (NTF) had greater reduction in the measurement of MMO (p=0.031). The remaining variables showed no statistically significant difference. CONCLUSION: Patients with H&NC present reduction of the measures of MO and MMO during the RT, especially if they present reduced functional capacity, have radiation in the mouth and oropharynx fields and used NTF.

Evaluation of acute radiation effects on mandibular movements of patients with head and neck cancer / Avaliação dos efeitos agudos da radioterapia sobre os movimentos mandibulares de pacientes com câncer de cabeça e pescoço

OBJECTIVES: To evaluate radiotherapy effects (RT) on mandibular movements of patients with head and neck cancer (H&NC) and associate them to the variables: functional capacity, radiation field, disease staging, type of feeding, concomitant chemotherapy and total dose of RT. METHODS: Twenty-six patients with H&NC were followed up at the RT service. Physical examination was performed in 3 follow up time points: before the beginning of RT (T0), between 14th and 17th session of RT (T1) and after the last session of RT (T2). The physical examination consisted of the assessment of the following variables: mouth opening without pain (MO), maximum mouth opening (MMO), right lateral excursion (RLE), left lateral excursion (LLE) and protrusion (PR) of the jaw. The feeding type and the Karnofsky Performance Status Scale (KPS) were evaluated in each follow up time point. Data with regards to the tumor lesion and the RT were collected from the patient's clinical notes. RESULTS: There was a statistical significant reduction in the values of MO (p=0.006), MMO (p=0.001), LLE (p=0.006) and KPS (p=0.001). There was significant a statistical association among the reduction in KPS and decreased measure of MO (r=0.390, p=0.048) and MMO (r=0.435, p=0.026). The mouth and oropharynx radiation fields when combined showed a significant reduction for both the measure of MO (p=0.005) and for MMO (p=0.004). Patients who used nasoenteric tube feeding (NTF) had greater reduction in the measurement of MMO (p=0.031). The remaining variables showed no statistically significant difference. CONCLUSION: Patients with H&NC present reduction of the measures of MO and MMO during the RT, especially if they present reduced functional capacity, have radiation in the mouth and oropharynx fields and used NTF.

OBJETIVOS: Avaliar os efeitos da radioterapia (RT) sobre os movimentos mandibulares de pacientes com câncer de cabeça e pescoço (CCeP) e associá-los às variáveis: capacidade funcional, campo de radiação, estadiamento da doença, tipo de alimentação, quimioterapia concomitante e dose total de RT. MÉTODOS: Vinte e seis pacientes com CCeP foram acompanhados em um serviço de RT. O exame físico ocorreu em três momentos: antes do início da RT (M0), entre a 14º e 17º sessão (M1) e após a última sessão de RT (M2) para verificação de variáveis, como: abertura bucal sem dor (AB), abertura bucal máxima (ABm), excursão lateral direita (EXd), excursão lateral esquerda (EXe) e protrusão (PR) da mandíbula. O tipo de alimentação e a Escala de Karnofsky (EK) foram reavaliados em cada momento. Dados a respeito da lesão tumoral e RT foram coletados do prontuário do paciente. RESULTADOS: Houve redução significativa nos valores de AB (p=0,006), ABm (p=0,001), EXe (p=0,006) e EK (p=0,001). Houve associação estatisticamente significativa entre a redução na EK e a diminuição de AB (r=0,390; p=0,048) e de ABm (r=0,435; p=0,026). Os campos de radiação da boca e orofaringe, quando agrupados, apresentaram redução significativa tanto para a medida de AB (p=0,005) quanto para ABm (p=0,004). Os pacientes que utilizaram sonda nasoentérica (SNE) apresentaram maior redução da medida de ABm (p=0,031). As demais variáveis não apresentaram diferença estatisticamente significativa. CONCLUSÃO: Os pacientes com CCeP apresentam redução das medidas de AB e ABm no decorrer da RT, principalmente se apresentarem redução da capacidade funcional, tiverem irradiação para os campos da boca e orofaringe e fizerem uso de SNE.

Improving the capture of adverse event data in clinical trials: the role of the International Atomic Energy Agency.

PURPOSE: To report meetings of the Applied Radiation Biology and Radiotherapy section of the International Atomic Energy Agency (IAEA), organized to discuss issues surrounding, and develop initiatives to improve, the recording of adverse events (AE) in clinical trials. METHODS AND MATERIALS: A first meeting was held in Atlanta, GA (October 2004). A second meeting was held in Denver, CO (October 2005) and focused on AE data capture. The National Cancer Institute Common Terminology Criteria for Adverse Events, version 3 (CTCAE) was suggested during the first meeting as the preferred common platform for the collection and reporting of AE data in its clinical trials. The second meeting identified and reviewed the current weaknesses and variations in the capture of AE data, and proposals to improve the quality and consistency of data capture were discussed. RESULTS: There is heterogeneity in the collection of AE data between both institutions and individual clinicians. The use of multiple scoring systems hampers comparisons of treatment outcomes between centers and trials. There is often insufficient detail on normal tissue treatment effects, which leads to an underestimate of toxicity. Implementation of improved data capture was suggested for one of the ongoing IAEA clinical trials. CONCLUSIONS: There is a need to compare the quality and completeness of data between institutions and the efficacy of structured/directed vs. traditional passive data collection. Data collection using the CTCAE (with or without a questionnaire) will be investigated in an IAEA multinational trial of radiochemotherapy and high-dose-rate brachytherapy in cervical cancer.

Multinational assessment of some operational costs of teletherapy.

BACKGROUND AND PURPOSE: Decisions in planning radiotherapy facilities in countries with limited financial resources require information on economic factors to make provision for sustainability. This study aims at acquiring data on some of these factors involved in delivery of teletherapy in 11 countries of different economic status. PATIENTS AND METHODS: Representatives of three European, one African, three Latin American and four Asian countries, were identified from radiation oncology institutions that operated both cobalt and linac teletherapy machines. Productivity data were prospectively collected for the year 2002. A detailed log was recorded for each machine over an arbitrary two-week period. Data on quality assurance (QA), maintenance, the capital costs of each machine, and the source replacement costs for the cobalt units were also recorded. RESULTS: Both linear accelerators and cobalt machines treat more than 10,000 fractions per year per machine with 2.5 and 2.3 fields per fraction, respectively. The capital costs of the machines vary considerably, with a factor of more than 10 for linear accelerators. Cobalt sources show a huge variation in price. The median costs of QA and maintenance of a linac was US$ 41,000 compared to US$ 6000 for cobalt machines. This results for the economic factors considered in median costs per fraction of US$ 11.02 for linear accelerators and US$ 4.87 for cobalt machines. These figures do not include the costs for physicians. CONCLUSIONS: The variation of the costs per fraction is more due to the result of differences in machine usage and costs of equipment than of national economic status. A treatment fraction on a linac with functionality comparable to cobalt, costs 50% more than cobalt therapy. This project shows that it is possible to collect data on economic factors prospectively as well as retrospectively.

Auto-enxerto tumoral irradiado nas reconstruções dos tumores ósseos / Irradiated tumoral autograft in bone tumor reconstructions: preliminary evalaution in three cases

Os autores relatam sua avaliação preliminar em três casos de sarcomas ósseos em que usaram a irradiação como método de aniquilação das células tumorais e normais do fragmento ósseo ressecado. Tais excisões obedeceram aos critérios oncológicos, de margem de ressecção, preestabelecidos. As peças foram irradiadas com 300Gy depois de retiradas as partes moles e o tecido medular. Os segmentos tratados foram reimplantados no mesmo ato operatório. Dois casos tiveram a fíbula vascularizada colocada no interior do auto-enxerto e fixação com placa única especial. O resultado, com 20 meses de seguimento, foi muito satisfatório, concordante com a literatura mundial. Apesar do método ser ainda pouco utilizado e reconhecido pela maioria da comunidade médica, apresenta vantagens observáveis sobre os métodos alternativos existentes.

Tumores germinativos do testiculo: experiencia de 12 anos / Germ cell tumors of the testis: 12 years's experience

Os tumores de testiculo representam uma forma rara de neoplasia no sexo masculino. No periodo de 12 anos, foram atendidos 234 individuos portadores de tumor germinativo do testiculo, e destes, 173 foram seguidos no periodo pos-operatorio. Do total analisado, 137 eram seminomas que responderam satisfatoriamente ao tratamento e com sobrevida de 96 por cento em 3 anos, e 38 tumores nao-seminomatosos, cuja taxa de sobrevida foi de 84 por cento , no mesmo periodo. Dois pacientes apresentaram tumores em ambos os testiculos, de forma assincronica. O acompanhamento pos-operatorio medio foi de 36 meses

Tumor de Wilms em adulto: relato de um caso / Wilms' Tumor in adult: report of a case

O tumor de Wilms ou Nefroblastoma é a neoplasia renal mais comum em crianças. Embora a incidência precisa dessa lesäo em adultos seja dificil de se avaliar, sabe-se que a sua ocorrência näo é freqüente e que poucos casos tem sido descritos na literatura. O presente artigo relata um caso de tumor de Wilms em uma mulher de 30 anos. É feita uma revisäo de literatura e alguns comentários säo feitos sobre o problema