Study Protocol for Assessing the Efficacy of Compression Therapy Using Stockings and Sleeves to Prevent Docetaxel-Induced Peripheral Neuropathy in Breast Cancer Patients

Taxanes are key drugs for patients with breast cancer. A major adverse effect associated with the administration of the taxane docetaxel is chemotherapy-induced peripheral neuropathy (CIPN). We are conducting a singlecenter, single-arm, open-label historical control trial to evaluate the ability of compression therapy using stockings or sleeves to prevent CIPN due to docetaxel treatment. The primary endpoint is the incidence of all-grade CIPN according to patients’ records until 3 weeks after the fourth docetaxel administration. This study’s results will clarify whether compression therapy using stockings or sleeves can prevent CIPN in breast cancer patients

The preoperative thyroid function and perioperative course in patients with Graves\u27 disease

Graves\u27 disease is an autoimmune disorder that induces increase in thyroid hormone production and release. Although euthyroidshould be desirable to ensure a safe operation, some patients still undergo thyroidectomy with hyperthyroidism. The aimof this study was to evaluate our preoperative strategies in patients with Graves\u27 disease. A total of 186 patients underwent thyroidectomy for Graves\u27 disease between 2003 and 2017. We gave all of these patients potassium iodide (KI) in order todecrease their thyroid hormone levels. We compared the clinical factors among three groups defined by the value of serumfree triiodothyronine (FT3) after the administration of KI: (1) the good control group (n=126) with ?6.0 pg/mL, (2) the fair control group (n=35) with >6.0 but ?10.0 pg/mL, and (3) the poor control group (n=25) with >10.0 pg/mL. KI decreased the serumlevels of thyroid hormone. However, some patients still had hyperthyroidism, and the subsequent administration of corticosteroidreduced FT3 but not thyroxine. Regarding the intraoperative course, the heart rate at 1 h after beginning general anesthesiawas higher in the poor control group than in the good control group (p<0.05), and the proportion of patients givenadrenergic beta-blocker was higher in the poor control group than in the other groups (p<0.01 each). One patient in the faircontrol group experienced suspected thyroid storm after total thyroidectomy. The occurrence rate of other deteriorations wasidentical among the three groups. With preparative KI and corticosteroid administration, almost all patients with Graves\u27 disease were able to undergo thyroidectomy safely

The Efficacy of Software to Help Patients Understand Drug for Adjuvant Treatment for Breast Cancer: A Pilot Randomized Controlled Trial

We assessed the usefulness of ChemoCalc, a software package for calculating drug costs, in helping patients understand these costs. We randomly assigned, in a 1 : 1 ratio, 20 women who had undergone surgery for early breast cancer to a group that discussed adjuvant treatment with their physicians using the ChemoCalc software (ChemoCalc group) or a group that discussed adjuvant treatment without ChemoCalc (Usual Explanation group). The participants completed a five-grade evaluation questionnaire after these discussions. The primary endpoint was the intergroup comparison of the questionnaire scores regarding participants’ understanding of their treatment-associated drug costs. Median age was not significantly different between the ChemoCalc group and Usual Explanation group (57 vs. 50, respectively; p=0.27). Patients in the ChemoCalc group had a significantly higher perceived level of understanding of the drug cost than those in the Usual Explanation group (5 [4-5] vs. 2.5 [1-5], respectively; p=0.002). Scores related to the patients’ perception that understanding drug costs is an important part of breast cancer treatment were also higher in the ChemoCalc group than the Usual Explanation group (5 [2-5] vs. 3 [1-5], respectively; p=0.049). ChemoCalc was found to be useful for understanding drug costs

Protocol for studying the efficiency of ChemoCalc software in helping patients to understand drug treatment costs for breast cance

Survival of patients with breast cancer can be prolonged by treatment with drugs, particularly new molecular-targeted drugs. However, these agents can be expensive and such treatments can be “an economic burden.” In this ongoing trial, we aim to assess the usefulness of ChemoCalc, a software package for calculating drug costs, to help patients understand the financial outlays. In this multicenter, randomized controlled phase 2 trial, 106 patients with advanced breast cancer will be assigned to either the “ChemoCalc” or “Usual Explanation” group. Treatment using ChemoCalc will be discussed with patients in the ChemoCalc group, whereas standard treatments, without using ChemoCalc, will be discussed with patients in the Usual Explanation group. Subsequently, the participants will decide the treatment and complete a five-grade evaluation questionnaire; those in the Usual Explanation group will receive information about ChemoCalc. Investigators will report if patients subsequently decide to change treatments. The primary endpoint will be the scores of two key questions compared between the groups: “Did you understand the cost of treatment in today\u27s discussion?” and “Do you think the cost of treatment is important in choosing a treatment?“. The secondary endpoints will be to compare discrepancies between treatments recommended by physicians and those selected by patients, the time required for discussion, other questionnaire factors, and the relationship between Comprehensive Score for Financial Toxicity tool and treatment selection. This will be the first randomized controlled trial to assess the efficacy of software to help patients understand drug cost estimates and whether it subsequently affects treatment choice. This study will be conducted according to the CONSORT statement. All participants will sign a written consent form. The study protocol was reviewed and approved by the Clinical Research Review Board of Nagasaki University (19070801). The protocol (version 1) was designed and will be conducted in accordance with the Declaration of Helsinki (1964) and the Ethical Guidelines for Medical and Health Research Involving Human Subjects (2017). The findings will be disseminated through scientific and professional conferences, and in peer-reviewed journals

Study protocol for efficacy and safety of steroid-containing mouthwash to prevent chemotherapy-induced stomatitis in women with breast cancer: a multicentre, open-label, randomised phase 2 study

INTRODUCTION: Stomatitis is a frequent adverse event in patients undergoing chemotherapy for breast cancer. Stomatitis can hamper oral nutrition resulting in malnutrition, reduce quality of life and introduce the need for dose reductions and interruption of chemotherapy; however, there is currently no standard approach for preventing chemotherapy-induced stomatitis. We aimed to assess the safety and efficacy of a dexamethasone-based elixir mouthwash for preventing chemotherapy-induced stomatitis in patients with early breast cancer. METHODS AND ANALYSIS: In this multicenter, randomised, controlled phase 2 trial, we will randomly assign 120 women with early breast cancer undergoing chemotherapy to use of a dexamethasone-based elixir or standard oral care, to compare their preventive effects on chemotherapy-induced stomatitis. Patients will be assigned in a 1:1 ratio. Patients in the intervention group will receive chemotherapy, oral care and a dexamethasone-based elixir (10?mL 0.1?mg/mL; swish for 2?min and spit, four times daily for 9 weeks), and patients in the control group will receive chemotherapy and oral care. The primary endpoint is the difference in incidence of stomatitis between the two groups. The sample size allows for the detection of a minimum difference of 20% in the incidence of stomatitis between the two groups. Secondary endpoints are severity of stomatitis, duration of stomatitis, completion rate of chemotherapy and adverse events. ETHICS AND DISSEMINATION: All participants signed a written consent form, and the study protocol has been reviewed and approved by the Clinical Research Review Board of Nagasaki University (CRB7180001). TRIAL REGISTRATION NUMBER: UMIN Clinical Trials Registry (UMIN000030489)

The preoperative thyroid function and perioperative course in patients with Graves' disease

Graves' disease is an autoimmune disorder that induces increase in thyroid hormone production and release. Although euthyroid should be desirable to ensure a safe operation, some patients still undergo thyroidectomy with hyperthyroidism. The aim of this study was to evaluate our preoperative strategies in patients with Graves' disease. A total of 186 patients underwent thyroidectomy for Graves' disease between 2003 and 2017. We gave all of these patients potassium iodide (KI) in order to decrease their thyroid hormone levels. We compared the clinical factors among three groups defined by the value of serum free triiodothyronine (FT3) after the administration of KI: (1) the good control group (n=126) with ≤6.0 pg/mL, (2) the fair control group (n=35) with >6.0 but ≤10.0 pg/mL, and (3) the poor control group (n=25) with >10.0 pg/mL. KI decreased the serum levels of thyroid hormone. However, some patients still had hyperthyroidism, and the subsequent administration of corticosteroid reduced FT3 but not thyroxine. Regarding the intraoperative course, the heart rate at 1 h after beginning general anesthesia was higher in the poor control group than in the good control group (p<0.05), and the proportion of patients given adrenergic beta-blocker was higher in the poor control group than in the other groups (p<0.01 each). One patient in the fair control group experienced suspected thyroid storm after total thyroidectomy. The occurrence rate of other deteriorations was identical among the three groups. With preparative KI and corticosteroid administration, almost all patients with Graves' disease were able to undergo thyroidectomy safely

Association of quantitative analysis of intratumoral reduced E-cadherin expression with lymph node metastasis and prognosis in patients with breast cancer

Abstract Loss of E-cadherin expression is a poor prognostic factor in patients with breast cancer. Breast cancer cells co-cultured with adipocytes reportedly promote E-cadherin attenuation and tumor progression. The current study aimed to investigate the association of reduced E-cadherin expression with adipose tissue invasion (ATI) and prognosis in breast cancer. Surgical specimens were collected from 188 women with invasive ductal carcinoma of the breast who had undergone surgery without neoadjuvant treatment. We compared E-cadherin expression in ATI and invasive front (IF) using immunohistochemistry with ImageJ. Reduced E-cadherin expression was detected not only in the ATI area but also in the IF, and the degree of reduced E-cadherin expression was positively correlated with both areas. In patients with lymph node metastasis compared to those without, E-cadherin expression was reduced and this reduction was associated with poor recurrence-free survival. We concluded that E-cadherin expression is reduced not only at the ATI area but also at the IF of the tumor. Reduced E-cadherin expression is a clear prognostic factor for breast cancer. Hence, future research is warranted for establishing an objective and quantitative E-cadherin staining assay that will allow clinical use of E-cadherin as a prognostic factor

Bevacizumab +oral 5-fluorourasil versus intensive chemotherapy for the treatment of elderly patients with metastatic colorectal cancer

Aim: This study compared the efficacy and safety of Bmab+oral 5-Fluorourasil (Bmab+o-5-FU) including Bmab+Capecitabine (Cape) with that of intensive chemotherapy including L-OHP or CPT-11 for patients with metastatic colorectal cancer (mCRC).Methods: Between January 2006 and February 2017, 40 elderly (?70 years) chemotherapy-naive patients with mCRC (male/female=22/18; median age, 76.0 years) were retrospectively reviewed. The treatment regimens were Bmab+o-5-FU (n=19)and intensive regimens (n=21). Intensive regimens comprised 17 L-OHP and 4 CPT-11 doublet chemotherapies.Results: The median progression-free survival (PFS) with Bmab+o-5-FU and intensive regimens was 281 and 215 days, respectively. The median survival time with Bmab+o-5-FU and intensive regimens was 961 and 1,002 days, respectively. No significant differences were observed in the overall survival or PFS between Bmab+o-5-FU and the other regimens. The disease control rate was 94.7% with Bmab+o-5-FU and 81.0% with intensive regimens. The rate of grade ?3 hematologicaladverse events was 5.3% for Bmab+o-5-FU and 15.8% for intensive regimens.Conclusions: With its similar survival benefit to intensive regimens, high disease control rate and good feasibility, Bmab+o-5-FU seems a fine treatment choice for elderly mCRC patients

Bevacizumab +oral 5-fluorourasil versus intensive chemotherapy for the treatment of elderly patients with metastatic colorectal cancer

Aim: This study compared the efficacy and safety of Bmab+oral 5-Fluorourasil (Bmab+o-5-FU) including Bmab+Capecitabine (Cape) with that of intensive chemotherapy including L-OHP or CPT-11 for patients with metastatic colorectal cancer (mCRC). Methods: Between January 2006 and February 2017, 40 elderly (≥70 years) chemotherapy-naïve patients with mCRC (male/female=22/18; median age, 76.0 years) were retrospectively reviewed. The treatment regimens were Bmab+o-5-FU (n=19)and intensive regimens (n=21). Intensive regimens comprised 17 L-OHP and 4 CPT-11 doublet chemotherapies. Results: The median progression-free survival (PFS) with Bmab+o-5-FU and intensive regimens was 281 and 215 days, respectively. The median survival time with Bmab+o-5-FU and intensive regimens was 961 and 1,002 days, respectively. No significant differences were observed in the overall survival or PFS between Bmab+o-5-FU and the other regimens. The disease control rate was 94.7% with Bmab+o-5-FU and 81.0% with intensive regimens. The rate of grade ≥3 hematologicaladverse events was 5.3% for Bmab+o-5-FU and 15.8% for intensive regimens. Conclusions: With its similar survival benefit to intensive regimens, high disease control rate and good feasibility, Bmab+o-5-FU seems a fine treatment choice for elderly mCRC patients