potential to reduce inflammation, modulate epigenetic changes and affect biological processes involved in the pathogenesis of symptoms. The objective of this study was to determine if pretreatment dietary patterns are associated with the presence of symptoms 1-year after diagnosis. Methods: This was a longitudinal study of 295 newly diagnosed HNC patients. All patients completed a food frequency questionnaire and epidemiologic health survey. Self-reported symptoms were assessed pre-treatment and 1-year after diagnosis using a Likert scale ranging from "1: not at all bothered" by symptom to "5: extremely bothered". Symptom scores were dichotomized as "not at all" vs. "slight-extremely". Principal component analysis was used to derive pre-treatment dietary patterns. Multivariable logistic regression models examined the association of derived dietary patterns (fit by quartiles) and seven symptoms (trismus, xerostomia, dysphagia of liquids, dysphagia of solids, difficulty chewing, taste and mucositis). An overall symptom summary score was calculated (range 8-39) and dichotomized as <17 vs. !17. This cutoff was chosen by examining the distribution of scores and categorizing into two distinct subgroups naturally present in the data. Results: Two dietary patterns emerged: Prudent (high intakes of vegetables, fruit, fish, poultry, and whole grains) and Western (high intakes of red and processed meats, refined grains, potatoes, and French fries). After adjusting for age, baseline symptoms, tumor site, cancer stage, smoking, calories and HPV status, significant inverse associations were observed between pre-treatment Prudent pattern score and dysphagia of liquids (P ¼ 0.01), dysphagia of solids (P ¼ 0.02) and difficulty chewing (P ¼ 0.02) at 1 year post-diagnosis. A statistically significant inverse association was observed between the overall symptom summary score and the Prudent pattern (P < 0.001). No significant associations were observed between the Western pattern and symptoms. Conclusion: Consumption of a pre-treatment Prudent diet may help reduce the risk of symptoms such as dysphagia and difficulty chewing 1-year after diagnosis in HNC survivors.
Background: Observational studies suggest that physical activity following a diagnosis of breast cancer may be associated with a lower risk of recurrence and death. Some studies also suggest possible effect modification by disease stage, body mass index, and receptor status. To date, however, there are no randomized trials examining the effects of exercise on disease outcomes in any cancer patient group. Here, we report an exploratory follow-up of disease outcomes from the Supervised Trial of Aerobic versus Resistance Training (START). Patients and Methods: The START Trial was a Canadian multicenter trial that randomized 242 breast cancer patients starting adjuvant chemotherapy to either usual care (n = 82) or supervised aerobic (n = 78) or resistance (n = 82) exercise for the duration of their chemotherapy. The primary efficacy endpoint for this exploratory analysis was disease-free survival (DFS). Secondary endpoints were overall survival (OS), distant disease-free survival (DDFS), and recurrence-free interval (RFI). The two exercise arms were combined for the analysis (n = 160) and selected subgroups were explored. Results: After a median follow-up of 89 months (IQR 81 to 96), there were 25/160 (15.6%) DFS events in the exercise groups and 18/82 (22.0%) in the control group (log-rank p = 0.21). Eight-year DFS was 82.7% for the exercise groups compared with 75.6% for the control group (Hazard ratio [HR] = 0.68, 95% CI = 0.37-1.24). There were 13/160 (8.1%) deaths in the exercise groups and 11/82 (13.4%) in the control group (log-rank p = 0.21). Eight-year OS was 91.2% in the exercise groups compared with 82.7% in the control group (HR = 0.60, 95% CI = 0.27 to 1.33. There were 20/160 (12.5%) DDFS events in the exercise groups and 16/82 (19.5%) in the control group (log-rank p = 0.15). Eight-year DDFS was 86.7% in the exercise groups compared with 78.3% in the control group (HR = 0.62, 95% CI = 0.32 to 1.19). Finally, there were 20/160 (12.5%) RFI events in the exercise groups and 17/82 (20.7%) in the control group (Gray's p = 0.095). Eight-year cumulative incidence of RFI was 12.6% in the exercise groups compared with 21.6% in the control group (HR = 0.58, 95% CI = 0.30 to 1.11). Subgroup analyses for DFS and RFI suggested stronger effects for women who were overweight/obese, had stage II/III cancer, receptor positive tumors, HER2 positive tumors, received taxane-based chemotherapies, and received at least 85% of their intended chemotherapy dose-intensity. The most notable subgroup effect was for patients who received optimal chemotherapy dosing with a borderline significant effect for DFS (HR = 0.50, 95% CI = 0.25 to 1.01) and a significant effect for RFI (HR = 0.38, 95% CI = 0.18 to 0.81). Conclusions: In this exploratory follow-up of the START Trial, there was a suggestion that exercise during adjuvant chemotherapy may improve several efficacy endpoints although none achieved statistical significance. Nevertheless, the magnitude of the effects appear to be meaningful with absolute 8-year survival differences between 7% and 9% and relative rate reductions between 30% and 40%. The START Trial provides the first randomized data to suggest that adding exercise to standard chemotherapy for breast cancer may improve outcomes. A definitive phase III trial is warranted. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-08-01.
Background: Aerobic and resistance exercise, either separately or in combination, have been shown to improve physical functioning and manage some symptoms in breast cancer patients receiving chemotherapy. Few exercise trials, however, have compared different doses or types of exercise in breast cancer patients to identify the optimal exercise prescription. Here, we report the primary results of the Combined Aerobic and Resistance Exercise (CARE) Trial which compared two different doses and types of exercise for improving physical functioning and symptom management in breast cancer patients receiving chemotherapy. Methods: A multicenter trial in Canada randomized 301 breast cancer patients between 2008 and 2011 to thrice weekly, supervised exercise during chemotherapy consisting of either a standard dose of 25-30 minutes of aerobic exercise (STAN; n = 96), a higher dose of 50-60 minutes of aerobic exercise (HIGH; n = 101), or a combined dose of 50-60 minutes of aerobic and resistance exercise (COMB; n = 104). The primary endpoint was patient-reported physical functioning assessed by the Medical Outcomes Survey-Short Form (SF)-36. Secondary endpoints were other physical functioning scales, symptoms, physical fitness, and chemotherapy completion. Results: Between April 2008 and September 2011, we randomized 301 of 728 (41%) eligible patients. STAN, HIGH and COMB completed 88% (43/49), 82% (40/49), and 78% (39/50) of their prescribed aerobic exercise sessions. We obtained patient-reported outcome data from questionnaires on 99% of patients at each point during and after chemotherapy. Adjusted linear mixed-model analyses showed that neither HIGH (+0.8; 95% CI [-0.8 to 2.4]; p = 0.30) nor COMB (+0.5; 95% CI [-1.1 to 2.1]; p = 0.52) were statistically superior to STAN for the primary outcome. For important secondary outcomes, HIGH was superior to STAN for the SF-36 physical component summary (p = 0.041), SF-36 bodily pain (p = 0.015), and endocrine symptoms (p = 0.019). COMB was superior to STAN for endocrine symptoms (p = 0.009) and superior to STAN (p<.001) and HIGH (p<.001) for muscular strength. HIGH was superior to COMB for the SF-36 bodily pain (p = 0.035) and aerobic fitness (p = 0.030). No differences resulted for body composition or chemotherapy completion. Relative dose intensity was 93.9% in STAN compared to 92.7% in COMB and 91.6% in HIGH (p = 0.34). No serious adverse events were related to exercise. Conclusions: A higher dose of aerobic or combined exercise compared to a standard dose of aerobic exercise did not improve patient-reported physical functioning as assessed by the SF-36 physical functioning subscale. The CARE Trial did demonstrate that higher doses of aerobic or combined exercise of up to 50-60 minutes/session are safe and feasible and do not interfere with chemotherapy completion or exacerbate any symptoms. Moreover, a higher dose of aerobic exercise was shown to provide modest improvements in aerobic fitness, patient-reported physical functioning, bodily pain, fatigue, and endocrine symptoms whereas combined exercise improved muscular fitness and endocrine symptoms. Cancer care professionals can safely recommend higher doses of exercise during breast cancer chemotherapy in appropriately supervised settings. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr PD2-6.
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