bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase III evaluation of American ginseng (panax quinquefolius) to improve cancer-related fatigue: NCCTG trial N07C2.
Authors: Barton Debra L. , Liu Heshan , Dakhil Shaker R. , Linquist Breanna M. , Sloan Jeff A. , Nichols Craig R. , McGinn Travis W. , Balcueva Ernie P. , Seeger Grant R. , Loprinzi Charles L. 
Published: March 2020

9001 Background: Ginseng is popularly used as a treatment for fatigue, one of the most common and disabling symptoms in people diagnosed with cancer. It is termed an “adaptogen”, thought to help the body combat negative effects of stress. This trial was to evaluate 2,000 mg American Ginseng versus placebo for cancer-related fatigue (CRF). Methods: Patients with cancer undergoing or having completed curative intent treatment and experiencing fatigue, rated at least 4 on a numeric analogue fatigue scale (1-10) for ≥1 month, were eligible. Exclusion criteria included CNS lymphoma, brain malignancies, or prior use of ginseng or chronic systemic steroids. Other etiologies for fatigue, such as pain and sleep, were also excluded. Patients were randomized to receive, in a double blind manner, 2,000 mg/d of American Ginseng or placebo in BID dosing for 8 weeks. The primary endpoint was change from baseline in the general subscale of the Multidimensional Fatigue Symptom Inventory (MFSI) at 4 weeks. Other MFSI subscales and the fatigue-inertia subscale of the Profile of Mood States (POMS) were also analyzed. Data were transformed to a 0-100 scale. Results: 364 patients were enrolled from 10/2008 to 07/2011. Data at 4 and 8 weeks are provided for several fatigue endpoints in the table below; higher numbers are better. Mental, emotional and vigor subscales of the MFSI were not significantly different between arms. There were no statistically significant differences in any grade of toxicity or self reported side effects between ginseng and placebo. Conclusions: This trial provides data to support that American Ginseng reduces general and physical CRF over 8 weeks without side effects. The treatment did not provide significant reductions in fatigue at 4 weeks and did not impact mental, emotional, and vigor dimensions of fatigue. [Table: see text]
Long-term protective effects of the angiotensin receptor blocker telmisartan on epirubicin-induced inflammation, oxidative stress, and myocardial dysfunction.
Authors: Mantovani Giovanni , Dessi' Mariele , Piras Alessandra , Madeddu Clelia , Orgiano Laura , Cadeddu Christian , Antoni Giorgia , Mercuro Giuseppe 
Published: March 2020

9006 Background: Chronic inflammation, oxidative stress and renin-angiotensin system (RAS) play a significant role in chemotherapy-induced cardiotoxicity (CTX). Telmisartan (TEL), an antagonist of the angiotensin II type-1 receptor, reduces anthracycline (ANT)-induced CTX. Methods: A phase II placebo (PLA)-controlled randomized trial was carried out to assess the role of TEL in the prevention of cardiac subclinical damage induced by epirubicin (EPI). Forty-nine patients (mean age ± SD, 53.0±8 years), cardiovascular disease-free with cancer at different sites and eligible for EPI-based treatment, were randomized to one of two arms: TEL n=25; PLA n=24. A conventional echocardiography equipped with Tissue Doppler imaging, strain and strain rate (SR) was performed, and serum levels of proinflammatory cytokines, IL-6 and TNF-α, and oxidative stress parameters, reactive oxygen species (ROS) and glutathione peroxidase were assessed. All assessments were carried out at baseline, after every 100 mg/m2 EPI dose and at 6, 12 and 18-month follow-up (FU). Results: A significant reduction in the SR peak in both arms was observed at t2 (cumulative dose of 200 mg/m2 EPI) in comparison to t0. Conversely, at t3, t4 (300, 400 mg/m2 EPI), 6, 12 and 18-month FU, the SR increased reaching the normal range only in TEL arm, while in PLA arm SR remained significantly lower as compared to t0. The differences between SR changes in PLA and TEL arms were significant from 300 mg/m2 EPI (t3) up to 18 month-FU. IL-6 increased significantly in PLA arm at t2 compared to t0, but remained unchanged in the TEL arm. ROS levels also increased significantly at t2 vs. baseline in PLA arm, while remained unchanged in TEL arm. The mean change in ROS and IL-6 at t2 was significantly different between the two arms. At 3, 6, 12 and 18 month-FU, ROS and IL-6 decreased in comparison to t2 in PLA arm, while remained low in TEL arm. Conclusions: Our results suggest that TEL is able to reverse acute EPI-induced myocardial dysfunction and maintain a normal systolic function up to 18 month-FU. These effects are likely due to two different mechanisms, RAS blockade and prevention of chronic inflammation/oxidative stress.
Electronic self-report assessment for cancer: Results of a multisite randomized trial.
Authors: Berry Donna Lynn , Hong Fangxin , Halpenny Barbara , Wang Qian , Partridge Ann H. , Fann Jesse R , Wolpin Seth , Lober William B , Bush Nigel , Bosco Jaclyn Lee Fong , Parvathaneni Upendra , Amtmann Dagmar , Back Anthony 
Published: March 2020

9008 Background: Attending to symptoms and side effects promotes safe and effective delivery of cancer therapies. Providing focus to the patient’s report in the clinic can efficiently address the most important concerns, without extending visit times. The web-based electronic self report assessment for cancer (ESRA-C) and clinician summary has been shown to improve patient-clinician communication about symptoms and quality of life issues (SQI). The purpose of this trial was to evaluate the impact of an enhanced ESRA-C intervention (ESRA-C INT) on symptom outcomes. Methods: Patients (planned N=702) with all cancer types treated in stem cell transplant, medical oncology and radiation oncology at two comprehensive cancer centers used ESRA-C to self-report SQI during and after new anti-cancer therapy, with summary reports delivered to clinicians. Patients were randomized to standard ESRA-C (control) or ESRA-C INT adding the opportunity to self-monitor SQI between clinic visits and receive self-care SQI management education, plus custom coaching on how to report SQI to clinicians, all delivered via a secure web sites. We analyzed the intervention effect on Symptom Distress Scale (SDS) scores using a two-sided t-test and multivariate linear regression, adjusting for pre-selected covariates, including baseline SDS, age, service, and work status. Results: Among 757 patients (increased N due to involuntary attrition), demographic variables were balanced between groups except age (t=2.13; p=.03) with a younger INT group (mean 1.97 year difference). Of the 562 patients who completed final reports, the control group reported significantly higher SDS scores (t= 1.98; p = .048). A significant interaction between study group and age was observed; significantly lower SDS scores were found in the ESRA-C INT group among patients > 50 years (-1.95; p=.002), and no significant difference among patients < 50. Conclusions: Adding self-care and communication coaching to ESRA-C, a system to allow self-report and clinician notification of SQI, reduced symptom distress in a large sample of patients during and after active cancer treatment compared with ESRA-C alone. Patients over the age of 50, in particular, may benefit from the intervention.
Curcumin for radiation dermatitis: A randomized, double-blind, placebo-controlled clinical trial of 30 breast cancer patients.
Authors: Ryan Julie L. , Heckler Charles E , Ling Marilyn N , Williams Jacqueline P , Pentland Alice P , Morrow Gary R. 
Published: March 2020

9027 Background: Radiation dermatitis occurs in approximately 95% of patients receiving radiation therapy for cancer and often leads to pain and treatment delays. There is no standard treatment with demonstrated effectiveness for the prevention of radiation dermatitis. We conducted a randomized, double-blind, placebo-control clinical trial to assess the efficacy of curcumin, a potent antioxidant and anti-inflammatory component of turmeric, to reduce radiation dermatitis in 30 breast cancer patients. Methods: Eligible patients included adult females with non-inflammatory breast cancer or carcinoma in situ prescribed radiation therapy without concurrent chemotherapy. After randomization, patients took four 500 mg capsules of curcumin or placebo three times daily throughout their course of radiation therapy (total daily dose = 6.0 g). Weekly assessments included Radiation Dermatitis Severity (RDS) Score, presence/absence of moist desquamation, erythema measure, and McGill Pain and Symptom Inventory (SI) questionnaires. Results: The 30 evaluable patients were white (90%; mean age = 58.1 years) with ER+PR+ breast cancer (76.7%) who did not have total mastectomy (90%) or chemotherapy prior to start of radiation therapy (56.7%). No significant differences were observed between arms for demographics, compliance, erythema, pain, symptoms, or radiation skin dose. Standard pooled variances t-test showed that curcumin reduced RDS at end of treatment compared to placebo (mean RDS = 2.6 vs 3.4; p=0.008). Fisher’s exact test showed that curcumin significantly reduced the presence of moist desquamation at the end of radiation therapy (28.6% vs. 87.5 %; p=0.002). Repeated measures analysis confirmed divergence of RDS between curcumin and placebo arms at Week 5. Conclusions: Oral curcumin, 6.0 g daily during radiation therapy, reduced radiation dermatitis severity and moist desquamation in breast cancer patients. A multisite CCOP trial (N=700) is underway to confirm the effectiveness of curcumin to reduce radiation dermatitis severity during various radiation therapy regimens for breast cancer. Support: IND 75,444, Dermatology Foundation, KL2 RR024136, NCI PHS 1R25CA10618.
Social environment as a predictor of smoking cessation and recidivism in lung cancer survivors.
Authors: Eng Lawson , Su Jie , Palepu Prakruthi R. , Hon Henrique , Fadhel Ehab , Harland Luke , La Delfa Anthony , Habbous Steven , Kashigar Aidin , Cuffe Sinead , Leighl Natasha B. , Pierre Andrew , Goldstein David P. , Liu Geoffrey , Xu Wei 
Published: March 2020

9032 Background: Smoking during cancer treatment negatively impacts treatment, survival and quality of life. Lung cancer patients with a smoking history often continue to smoke; some ex-smokers re-start after diagnosis. Social environment impacts cessation and recidivism rates in non-cancer patients. We assessed whether the same influences occur among lung cancer patients. Methods: Lung cancer patients, recruited from Princess Margaret Hospital, completed a baseline questionnaire about their demographics and smoking history (at diagnosis). A follow-up questionnaire was administered at a median of two years, assessing changes in smoking habits, exposure at home/work/among friends, healthcare use, social support and alcohol use since diagnosis. The relationship between each variable with cessation/recidivism was analyzed. Odds ratios (OR) and 95% confidence intervals (95% CI) were calculated. Results: 478 patients completed both questionnaires. Of the 100 current smokers at diagnosis; 52 quit by the time of the follow-up questionnaire. Among 294 ex-smokers, 15 started to smoke after diagnosis. None of the 84 never smokers at baseline started to smoke after diagnosis. Exposure to smoking at home was associated with continued smoking and relapse (OR=5.1, 95% CI: 1.8–14.3, p=0.001; and OR=3.9, 95% CI: 0.8–14.4, p=0.04, respectively). Specifically, spousal smoking was associated with both continued smoking (OR=7.3, 95% CI: 2.4–21.7, p=2.0E-04) and recidivism (OR=3.7, 95% CI: 0.6–16.6, p=0.08). Having more than a few friends who smoke is associated with continued smoking (OR=3.5, 95% CI: 1.4–8.7, p=0.005) and relapse (OR=4.8, 95% CI: 1.5–15.0, p=0.004). Not completing high school was also associated with continued smoking (OR=3.0, 95% CI: 1.2–7.6, p=0.02). Multivariate analysis identified spousal smoking as the major single predictor of continued smoking (OR=8.8, 95% CI: 2.2–34.8, p=0.002). Conclusions: Smoking cessation programs for lung cancer patients should not only target the patient but also include the immediate family, consider a patient’s peers and be tailored to the patient’s education level. Involvement of the immediate family and consideration of peers may help prevent smoking relapse.
Patient information desire in actual decision making for advanced cancer treatment: Do doctors know their patients?
Authors: Oostendorp Linda JM , Ottevanger Petronella B , Van Der Graaf Winette T.A. , Stalmeier Peep FM 
Published: March 2020

9036 Background: Providing information is an important element of cancer care. While several studies have investigated patients' information desire, to our knowledge, this study is the first to involve patients facing an actual decision. We examined the information desire of patients at the point of decision making, the ability of doctors to judge this desire, and the information provided by the doctor. Methods: This prospective multicenter study included patients with advanced colorectal or breast cancer faced with the decision whether or not to pursue second-line chemotherapy. Patients received the usual treatment-related information from the doctor plus a decision aid from a nurse. The aid contained information on adverse events, tumor response, and survival. For each item, the nurse asked the patient whether the information was desired and whether it had been disclosed by the doctor and the doctor made a substitute judgment of the patient’s information desire on the inclusion form. The match between patient’s desire and doctor’s judgment was expressed in percentage agreement and agreement corrected for chance (κ). Results: By 01/2012, 71 patients had received the decision aid. Median age was 62 years (range 39-80), 38% were male, and 28% had college education or higher. Information on adverse events, tumor response, and survival was desired by 94%, 90%, and 73% of patients. The doctors judged that information desire would be 100%, 97%, and 81%, respectively. There was a poor match between doctor’s judgment and actual information desire for adverse events (94%, κ not applicable), tumor response (87%, κ = -0.049), and survival (61%, κ = -0.104). When asked whether the information was previously disclosed by the doctor, 73%, 57%, and 30% of patients answered affirmatively. Conclusions: Patients expressed a high information desire, which was accurately judged by the doctors. However, doctors were unable to judge an individual patient’s information desire beyond chance. According to the patients, doctors did not disclose all desired information, especially on survival. Decision aids, similar to those used here, have been shown to help doctors provide safe, effective, and timely information to patients.
Patient-reported satisfaction with reconstructed breasts in the long-term survivorship period: Comparison of autologous and nonautologous breast reconstruction.
Authors: Scott Amie , Ho Adelyn , Klassen Anne , Cano Stefan , VanLaeken Nancy , Cordeiro Peter , Pusic Andrea 
Published: March 2020

9043 Background: Breast cancer patients undergoing mastectomy may choose to have reconstruction performed using either their own tissue or an implant. As many patients are candidates for both, valid and reliable patient-centered outcomes data are crucial to shared medical decision-making. The objective of this study is to determine whether patient-reported satisfaction with their reconstructed breasts is dependent on type of reconstructive surgery and length of time from reconstruction. Methods: Participants were recruited from Memorial Sloan-Kettering Cancer, NY and the University of British Columbia, Canada. Patients completed the BREAST-Q, a new patient-reported outcome measure for breast surgery patients. The dependent variable was the BREAST-Q Satisfaction with Breast score, a 16-item scale scored from 0-100. Procedure type, time since surgery, and patient characteristics were independent variables. Univariate analysis and clinical judgment were used to identify variables included in the model, and multivariate linear regression models were constructed to control for confounders. Results: The study sample consisted of 510 women (response rate 62%). The sample was on average aged 54.3 ± 9.3 (range 21-81), surveyed 3.71 years ± 1.55 (range 1-9) after surgery, 66% were reconstructed using an implant. Type of surgery and laterality were found to be variables that predicted higher patient satisfaction with their breasts after controlling for radiation therapy, follow-up time, timing of surgery, age, body mass index, and major complications (surgery type p<0.001; laterality p<0.001, R-square=0.17). Conclusions: As there is a growing population of breast cancer survivors, understanding how a woman’s satisfaction with her reconstructed breasts changes over time is essential. This study suggests that patient satisfaction with breast reconstruction depends on the type of reconstruction a woman undergoes. This patient-centered outcome data can be used to enhance shared medical decision-making by providing patients with information about realistic expectations for satisfaction with breasts related to type of surgery chosen.
Predictors of satisfaction with decision in patients with advanced cancer.
Authors: Hitz Felicitas , Klingbiel Dirk , Ribi Karin , Li Qiyu , Cerny Thomas , Koeberle Dieter 
Published: March 2020

9045 Background: Treatment decisions in palliative cancer care depend on various patient-, treatment, and disease-related factors. This study investigated patients’ satisfaction with decision and decision-making preferences in a Swiss oncology network and evaluated factors that predict satisfaction with decision (SWD). Methods: Patients receiving a new line of palliative cancer treatment completed a multi-dimensional questionnaire 4-6 weeks after treatment decision. Patient-reports comprised socio-demographic information, satisfaction with decision (primary endpoint), subjective treatment goal, preferences for decision-making, health, locus of control, and several quality of life (QoL) domains. Information on diagnosis, line of therapy, metastases, prognosis, performance status and duration of consultation were provided by the attending physician. Predictors of SWD (range: 0=worst; 30=best) were evaluated by uni- and multivariate (primary analysis, 80% power, 5% significance level) regression models. We consider ≥24 points as high SWD. Results: 445 out of 480 patients treated in 8 hospitals and 2 private practices completed all questions regarding the primary endpoint. 44% of patients preferred shared-, 42% physician-centered decision making. Median duration of consultation was 30 minutes (range 10-200 minutes). Overall, 326 (73%) patients reported high SWD. In univariate analyses various factors (e.g. global and physical QoL, performance status, treatment goal, locus of control, prognosis and duration of consultation) were significant predictors of SWD. The only significant predictor in the multivariate analysis was duration of consultation, which was positively associated with SWD (p=0.01). Conclusions: SWD is generally high in patients with advanced cancer treated in an oncology network in Switzerland. Our results indicate that duration of consultation is a very important factor among many others in predicting SWD. In busy clinical practice, taking your time with patients may be a simple measure to enhance patients’ SWD.
Mistletoe as complementary treatment in patients with advanced non-small cell lung cancer treated with carboplatin-based combinations: A randomized phase II study.
Authors: Bar-Sela Gil , Wollner Mira , Hammer Liat , Agbarya Abed , Dudnik Elizabeth , Haim Nissim 
Published: March 2020

9052 Background: The mistletoe preparation, iscador, is commonly used in complementary medicine for improving the quality of life (QoL) of cancer patients, but its efficacy needs to be further proved. This randomized phase II study was aimed at assessing the value of iscador as a modifier of chemotherapy-induced toxicity in chemotherapy-naïve non-small-cell lung cancer (NSCLC) patients treated with carboplatin containing regimens. Methods: Patients with stage IIIA or IIIB/IV NSCLC, ECOG performance status 0-2, and no history of brain metastasis were randomized to receive either chemotherapy alone (arm-1) or chemotherapy plus iscador Q 10mg SC injections 3 times weekly until tumor progression (arm-2). Chemotherapy consisted of 21-day cycles of IV carboplatin area under curve 5.0, day 1, combined with IV gemcitabine 1000mg/m2, days 1, 8, or with IV pemetrexed 500mg/m2, day 1. Results: Seventy-two patients were enrolled, 39 to arm-1 and 33 to arm-2. The arms were well balanced except that more patients with PS-0 were in arm-1 (p=0.041). Most patients (65%) were in stage IV and 62% had squamous histology. Median overall survival was 11 months in both arms. Median TTP was 4.8 months (arm-1) and 6 months (arm-2) (p=0.07). Carboplatin dose reductions and delays in gemcitabine on day 8 were more frequent in arm-1 (44% vs. 13% in arm-2, p<0.005; 31% vs. 13% in arm-2, p< 0.013). The difference in grade 3-4 hematological toxicity was not significant. More non-hematological toxicity was observed in arm-1 (41% compared to 16% in arm-2, p=0.043). The number of hospitalizations was higher in arm-1, 54%, compared to 24% in arm-2 (p=0.016). No significant difference was seen in QoL using the EORTC QLQ-C30 questionnaire; However, significant improvement in arm-2 was seen in coughing (p=0.013) and peripheral neuropathy (p=0.019). Conclusions: Chemotherapy dose reductions, severe non-hematological side effects, and hospitalizations were less frequent in patients treated with iscador. Further investigation of iscador as a modifier of chemotherapy-related toxicity is warranted.
Prospective survey study regarding the implementation of new communication skills curriculum for medical oncology trainees.
Authors: Shumway Nathan M. , Struble Erika J. 
Published: March 2020

9058 Background: After a diagnosis of cancer, many patients suffer from anxiety and distress from uncertainty of symptoms, treatments, and prognosis. Clinicians must recognize opportunities to explore concerns. This study assesses oncology trainees’ views about communication with cancer patients before (PRE) and after (POST) a 12 month curriculum. Methods: Medical oncology fellows were surveyed PRE and POST a communication curriculum consisting of case studies and 6 core lectures which included fundamentals, breaking bad news, transitions to palliative care, advanced care planning, conducting family conferences, and discussing treatment options and informed consent. A 5 point Likert-scale was used to measure fellows’ attitudes and comfort regarding communication PRE and POST with questions grouped according to core topics. (≤2 = trainee disagreement, 3=neutral opinion, and ≥ 4 indicated agreement). Results: PRE and POST surveys were completed by 11 and 8 trainees respectively. In PRE 100% felt communication skills were important and 63% believed these skills could be taught. 82% felt there was not enough time during most visits to address emotion. This decreased to 27% in POST. 18% PRE agreed they were comfortable recognizing coping mechanisms versus 100% POST. 45% felt comfortable eliciting values in PRE versus 87.5% POST. Only 1 fellow (9%) felt comfortable addressing futility in PRE versus 25% in POST. The median grouped score for fundamentals increased from 15 to 17 (p=0.016) and median grouped score for advance care plans and DNR increased from 11 to 13(p=0.026). Conclusions: There is a need to improve oncology communication skills. Our curriculum is just one approach. After intervention, the majority of fellows agreed there was enough time to address emotion and felt more comfortable recognizing coping mechanisms and eliciting values. Discussing futility remains difficult for our fellows. All fellows were more comfortable with fundamental communication skills and advance care plans after the curriculum. The extent the curriculum contributed to the change in survey results is unclear. Further research is needed to guide communication education of oncologists.