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.

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.