Systemic chemotherapy before cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) in patients with high-grade mucinous carcinoma peritonei of appendiceal origin.

BACKGROUND: The role of systemic chemotherapy (SC) before cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) in appendiceal high-grade mucinous carcinoma peritonei (HGMCP) is controversial. We analyzed the effect of SC prior to CRS/HIPEC in HGMCP. METHODS: A prospective database of CRS/HIPEC procedures for HGMCP without signet ring cells and with signet ring cells (HGMCP-S) from 1998 to 2017 was reviewed. Exclusion criteria was prior surgery >5 regions or >2 regimens of prior SC. Perioperative variables were analyzed. RESULTS: There were 140 HGMCP/HGMCP-S identified: 64 with prior SC (preSC) and 76 without (noSC). Groups were balanced for lymph node status, complete cytoreduction rate, disease burden, complications, and postoperative SC. PreSC had more HGMCP-S, moderately/poorly differentiated histology, and longer time-to-surgery (median: 6 vs 2 months, p < 0.001). Median overall survival (mOS) was 40 vs 86 and median progression-free survival (mPFS) was 19 vs 43 months for preSC vs noSC, respectively (p = 0.006 and p = 0.007). In HGMCP-S subanalysis, mOS was 25 vs 39 and mPFS 16 vs 29 months for preSC vs noSC, respectively (p = 0.188 and p = 0.063). In moderately/poorly differentiated histology subanalysis, mOS was 38 vs 56 and mPFS 18 vs 29 months in preSC vs noSC, respectively (p = 0.199 and 0.082). Prior SC was not linked to improved OS or PFS in non-signet ring HGMCP or well-differentiated histology subanalysis. CONCLUSION: Prior SC was not associated with less disease burden, better cytoreduction rates, or improved clinical outcomes in HGMCP, regardless of histopathologic subtype. Traditional SC agents may not be effective in HGMCP in the neoadjuvant setting.

STRONG-D: Strength training regimen for normal weight diabetics: Rationale and design.

BACKGROUND: Currently, there is a lack of data on effective lifestyle recommendations for normal-weight diabetics (NWD), who can represent up to 1 in 5 individuals with Type II Diabetes Mellitus (T2DM). NWD is especially prevalent in Asian populations and the elderly. Specific exercise treatment recommendations are needed for patients with normal-weight diabetes (NWD), as those in this category face higher mortality rates than overweight and obese diabetics. Standard T2DM treatment recommends aerobic training; however, performing aerobic training alone may not be appropriate for NWD and strength training may be a more effective treatment recommendation. OBJECTIVE: While it is known that strength and aerobic training are beneficial in obese diabetics, there is currently insufficient evidence to recommend this regimen in NWD. The Strength Training Regimen for Normal Weight Diabetics (STRONG-D) study aims to determine the best exercise regimen for NWD and address the current lack of appropriate physical activity recommendations for this population. The primary goal of this study is to determine whether strength training aids glycemic control better than aerobic training in NWD. STUDY DESIGN: STRONG-D is a three-arm randomized controlled trial designed to compare the clinical effectiveness of structured strength training only, aerobic training only, and combination (strength + aerobic) training sessions, modeled after the intervention in the Health Benefits of Aerobic and Resistance Training in T2DM patients (HART-D) study. Potential participants meeting eligibility criteria of HbA1c values of 6.5% to 13.0% and BMI of 18.5 kg/m2 to 25 kg/m2 will be enrolled. After randomization, participants will begin a 9-month exercise intervention. The primary outcomes will be HbA1c levels. The secondary endpoints will include physical fitness, body composition measured by Dual X-Ray Absorptiometry (DXA) scans, and leg strength and endurance measured by Biodex testing. Initial follow-up visits will occur at 3 months, 6 months, and 9 months. To determine the long-term effects of the exercise intervention, passive follow-up will continue via electronic health records (EHR) until a 24-month follow-up visit. A total of 282 participants will be randomized into the three study arms determine the clinically significant differences between strength-only, aerobic-only and combination regimens.

Evaluating the clinical implementation of structured exercise: A randomized controlled trial among non-insulin dependent type II diabetics.

BACKGROUND: The American Diabetes Association (ADA) currently recommends 150 min of moderate-intensity aerobic exercise per week and resistance exercise at least twice per week in individuals with type 2 diabetes (T2DM) to improve overall health [1]. However, approximately 38% of patients with T2DM do not exercise at recommended levels and 31% do not exercise at all [2]. The efficacy of structured exercise interventions has been proven effective in reducing glycosylated hemoglobin A1c (HbA1c) levels in patients, but practical approaches are needed to translate these findings into the clinical setting [3-7]. OBJECTIVE: The Initiate and Maintain Physical Activity in Clinics (IMPACT) Study aims to compare structured group exercise within the clinic to usual care in T2DM patients. The main purpose of the study is to determine the optimal and feasible level and weekly frequency of structured contact in a clinical setting needed to initiate and maintain physical activity recommendations long-term. STUDY DESIGN: IMPACT is a longitudinal, randomized-controlled study designed to track study participants over 30 months. Once study participants have met eligibility and enrollment criteria, they are randomized and enrolled into one of three arms: 1× per week exercise, 3× per week exercise, or the usual care control group. After randomization, participants begin Phase 1: Initiate lasting 6 months. Over the course of Phase 1, participants in the exercise groups will attend instructor led group training at a Stanford approved physical fitness facility. At the end of 6 months, participants enter Phase 2: Maintain lasting 24 months. Over the course of Phase 2, participants in all three arms will attend periodic follow-up visits for clinical measurements and survey administration for their final two years of participation. These findings will enable the clinical implementation of a structured exercise regimen designed to specifically address the aerobic and resistance training recommendations for patients with T2DM.