Occurrence of breast-cancer-related lymphedema after reverse lymphatic mapping and selective axillary dissection versus standard surgical treatment of axilla: A two-arm randomized clinical trial.

BACKGROUND: The need for axillary dissection (AD) is declining, but it is still essential for many patients with nodal involvement who risk developing breast-cancer-related lymphedema (BCRL) with lifelong consequences. Previous nonrandomized studies found axillary reverse mapping and selective axillary dissection (ARM-SAD) a safe and feasible way to preserve the arm's lymphatic drainage. METHODS: The present two-arm prospective randomized clinical trial was held at a single comprehensive cancer center to ascertain whether ARM-SAD can reduce the risk of BCRL, compared with standard AD, in patients with node-positive breast cancer. Whatever the type of breast surgery or adjuvant treatments planned, 130 patients with nodal involvement met our inclusion criteria: 65 were randomized for AD and 65 for ARM-SAD. Twelve months after surgery, a physiatrist assessed patients for BCRL and calculated the excess volume of the operated arm. Lymphoscintigraphy was used to assess drainage impairment. Self-reports of any impairment were also recorded. RESULTS: The difference in the incidence of BCRL between the two groups was 21% (95% CI, 3-37; p = .03). A significantly lower rate of BCRL after ARM-SAD was confirmed by a multimodal analysis that included the physiatrist's findings, excess arm volume, and lymphoscintigraphic findings, but this was not matched by a significant difference in patients' self-reports. CONCLUSIONS: Our findings encourage a change of surgical approach when AD is still warranted. ARM-SAD may be an alternative to standard AD to reduce the treatment-related morbidity.

Red clover and lifestyle changes to contrast menopausal symptoms in premenopausal patients with hormone-sensitive breast cancer receiving tamoxifen.

PURPOSE: To determine whether a red clover preparation plus dietary intervention administered to premenopausal women with breast cancer (BC), improves menopausal symptoms due to anti-oestrogen treatment, and hence promotes compliance with tamoxifen, prevents weight gain and is safe. METHODS: Surgically-treated premenopausal women with oestrogen receptor (ER) positive disease taking tamoxifen were recruited to a prospective double-blind randomized trial (NCT03844685). The red clover group (N = 42) received one oral tablet/day (Promensil® Forte) containing 80 mg red clover extract for 24 months. The placebo group (N = 39) received one oral tablet/day without active ingredient. All women were encouraged to follow a Mediterranean-type diet and keep active. Outcomes were Menopausal Rating Score (MRS), body mass index (BMI), waist and hip girth, insulin resistance, and levels of cholesterol, triglycerides, and sex hormones. As safety indicators, endometrial thickness, breast density, and effects of patient serum on ER-positive BC cell lines were investigated. RESULTS: MRS reduced significantly (p < 0.0001) with no between-group difference (p = 0.69). The red clover group had significantly greater reductions in BMI and waist circumference (p < 0.0001 both cases). HDL cholesterol increased significantly in both groups (p = 0.01). Hormone levels and insulin resistance changed little. Endometrial thickness remained constant (p = 0.93). Breast density decreased significantly in both groups (p < 0.0001). Proliferation and oestrogen-regulated gene expression didn't differ in cell lines treated with serum from each group. CONCLUSIONS: This is the first trial to assess red clover in BC patients on tamoxifen. The preparation proved safe clinically and in vitro, and was associated with reduced BMI and waist circumference, but the diet-lifestyle intervention probably improved the menopausal symptoms.

Ghost ileostomy after anterior resection for rectal cancer: a preliminary experience.

PURPOSE: The aim of this study was to describe and evaluate the feasibility and the eventual advantages of ghost ileostomy (GI) versus covering stoma (CS) in terms of complications, hospital stay and quality of life of patients and their caregivers after anterior resection for rectal cancer. METHODS: In this prospective study, we included patients who had rectal cancer treated with laparotomic anterior resection and confectioning a stoma (GI or CS), in the period comprised between January 2008 and January 2009. Short-term and long-term surgery-related mortality and morbidity after primary surgery (including that stoma-related and colorectal anastomosis-related) and consequent to the intervention of intestinal recanalization (CS group) and GI closure were evaluated. We evaluated hospital stay and quality of life of patients and their caregivers. RESULTS: Stoma-related morbidity rate was higher in the CS group than in GI group (37% vs. 5.5%, respectively, P = 0.04). Morbidity rate after intestinal recanalization in the CS group was 25.9% and 0% after GI closure (P = 0.08). Overall stoma morbidity rate was significantly lower in the GI group with respect to CS group (5.5% vs. 40.7%, respectively, P = 0.03). CS group was characterized by a significantly longer recovery time (P = 0.0002). Caregivers and stoma-related quality of life were better in the GI group than in CS group (P < 0.0001 and P = 0.0005, respectively). CONCLUSIONS: GI is feasible, characterized by shorter recovery, lesser degree of total, as well as anastomosis-related morbidity and higher quality of life of patients and the caregivers in respect to CS. We suggest that GI (should be evaluated as an alternative to conventional ileostomy) could be indicated in selected patients that do not present risk factors, but require caution for anastomotic leakage for the low level of colorectal anastomosis.