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Influence of pre-operative oral carbohydrate loading vs. standard fasting on tumor proliferation and clinical outcome in breast cancer patients ? a randomized trial.

ABSTRACT: BACKGROUND:Conflicting results have been reported on the influence of carbohydrates in breast cancer. OBJECTIVE:To determine the influence of pre-operative per-oral carbohydrate load on proliferation in breast tumors. DESIGN:Randomized controlled trial. SETTING:University hospital with primary and secondary care functions in South-West Norway. PATIENTS:Sixty-one patients with operable breast cancer from a population-based cohort. INTERVENTION:Per-oral carbohydrate load (preOp™) 18 and 2-4?h before surgery (n?=?26) or standard pre-operative fasting with free consumption of tap water (n?=?35). MEASUREMENTS:The primary outcome was post-operative tumor proliferation measured by the mitotic activity index (MAI). The secondary outcomes were changes in the levels of serum insulin, insulin-c-peptide, glucose, IGF-1, and IGFBP3; patients' well-being, and clinical outcome over a median follow-up of 88?months (range 33-97?months). RESULTS:In the estrogen receptor (ER) positive subgroup (n?=?50), high proliferation (MAI???10) occurred more often in the carbohydrate group (CH) than in the fasting group (p?=?0.038). The CH group was more frequently progesterone receptor (PR) negative (p?=?0.014). The CH group had a significant increase in insulin (+?24.31 mIE/L, 95% CI 15.34 mIE/L to 33.27 mIE/L) and insulin c-peptide (+?1.39?nM, 95% CI 1.03?nM to 1.77?nM), but reduced IGFBP3 levels (-?0.26?nM; 95% CI -?0.46?nM to -?0.051?nM) compared to the fasting group. CH-intervention ER-positive patients had poorer relapse-free survival (73%) than the fasting group (100%; p?=?0.012; HR?=?9.3, 95% CI, 1.1 to 77.7). In the ER-positive patients, only tumor size (p?=?0.021; HR?=?6.07, 95% CI 1.31 to 28.03) and the CH/fasting subgrouping (p?=?0.040; HR?=?9.30, 95% CI 1.11 to 77.82) had independent prognostic value. The adverse clinical outcome of carbohydrate loading occurred only in T2 patients with relapse-free survival of 100% in the fasting group vs. 33% in the CH group (p?=?0.015; HR?=?inf). The CH group reported less pain on days 5 and 6 than the control group (p?

SUBMITTER: Lende TH

PROVIDER: S-EPMC6842165 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Influence of pre-operative oral carbohydrate loading vs. standard fasting on tumor proliferation and clinical outcome in breast cancer patients ─ a randomized trial.

Lende Tone Hoel TH Austdal Marie M Varhaugvik Anne Elin AE Skaland Ivar I Gudlaugsson Einar E Kvaløy Jan Terje JT Akslen Lars A LA Søiland Håvard H Janssen Emiel A M EAM Baak Jan P A JPA

BMC cancer 20191108 1

<h4>Background</h4>Conflicting results have been reported on the influence of carbohydrates in breast cancer.<h4>Objective</h4>To determine the influence of pre-operative per-oral carbohydrate load on proliferation in breast tumors.<h4>Design</h4>Randomized controlled trial.<h4>Setting</h4>University hospital with primary and secondary care functions in South-West Norway.<h4>Patients</h4>Sixty-one patients with operable breast cancer from a population-based cohort.<h4>Intervention</h4>Per-oral c ...[more]

PMID: 31703648

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Project description:BackgroundFemur fracture is a major burden among elderly people, leading patients to be bedridden for a long time in the hospital. The body is more likely to be in a catabolic state as a result of the prolonged fasting period required for surgery, leading to an increase in insulin resistance. Pre-operative carbohydrate loading has been shown to improve postoperative outcomes in several countries. The study aimed to evaluate the effect of pre-operative carbohydrate loading in femur fracture surgery.MethodsThis study was single-center, hospital-based, open-label, parallel-group randomized controlled trial conducted between August 2020 and November 2021. A total of 66 participants, aged 50 years and above having femur fractures planned for surgery were included in this study and assigned to the control (n = 33) and study (n = 33) groups through computer-generated random numbers. The control group was kept fasting from midnight to the next morning as in existence while the study group was intervened with carbohydrate loading according to the Enhanced Recovery After Surgery (ERAS) protocol. The pre-operative nutritional status was identified and the postoperative outcomes were measured using the Visual Analogue Score (VAS), Cumulative Ambulatory Score (CAS), and Modified Barthel Index (MBI) scoring systems. Statistical analyses were performed using the Chi-square test and the Student's two-sample t-test to compare the outcomes between the two groups.ResultsAll the participants completed the study. There was a significant reduction in the average postoperative pain in the carbohydrate loading group (VAS: 4.8 (SD ± 1.8), 95% CI: 4.7-5.4) as compared to the control group (VAS: 6.1 (SD ± 2.1), 95% CI: 5.3-6.8). The average CAS showed a significant improvement in regaining the mobility function of participants in the study group (CAS: 8.1 (SD ± 2.8), 95% CI: 7.1-9.1) than that of the control group (CAS: 6.8 (SD ± 2.8), 95% CI: 5.8-7.8). The mean MBI score of the participants at the time of discharge from the hospital was higher in the study group (MBI:13.1 (SD ± 2.3), 95% CI: 12.2-13.9) compared to the control group (MBI: 11.8 (SD ± 3.1), 95% CI:10.6-12.9). Similarly, the length of hospital stay after surgery had decreased in the study group than in the control group.ConclusionsThe uptake of carbohydrate loading showed reduced post-operative pain, enhanced functional mobility, and decreased length of hospital stay. This study warrants larger trials to show the effect of pre-operative carbohydrate loading in a clinical setting.Trial registrationNCT04838366, first registered on 09/042021 ( https://clinicaltrials.gov/ct2/show/NCT04838366 ).

Project description:Background and objectivesAlmost one third of cancer patients in the United States will develop brain metastases on an annual basis. Surgical resection is indicated in the setting of brain metastases for reasons, such as maximizing local control in select patients, decompression of mass effect, and/or tissue diagnosis. The current standard of care following resection of a brain metastasis has shifted from whole brain radiation therapy to post-operative stereotactic radiosurgery (SRS). However, there is a significant rate of local recurrence within one year of postoperative SRS. Emerging retrospective and prospective data suggest pre-operative SRS is a safe and potentially effective treatment paradigm for surgical brain metastases. This trial intends to determine, for patients with an indication for resection of a brain metastasis, whether there is an increase in the time to a composite endpoint of adverse outcomes; including the first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis - in patients who receive pre-operative SRS as compared to patients who receive post-operative SRS.MethodsThis randomized phase III clinical trial compares pre-operative with post-operative SRS for brain metastases. A dynamic random allocation procedure will allocate an equal number of patients to each arm: pre-operative SRS followed by surgery or surgery followed by post-operative SRS.Expected outcomesIf pre-operative SRS improves outcomes relative to post-operative SRS, this will establish pre-operative SRS as superior. If post-operative SRS proves superior to pre-operative SRS, it will remain a standard of care and halt the increasing utilization of pre-operative SRS. If there is no difference in pre- versus post-operative SRS, then pre-operative SRS may still be preferred, given patient convenience and the potential for a condensed timeline.DiscussionEmerging retrospective and prospective data have demonstrated some benefits of pre-op SRS vs. post-op SRS. This study will show whether there is an increase in the time to the composite endpoint. Additionally, the study will compare overall survival; patient-reported outcomes; morbidity; completion of planned therapies; time to systemic therapy; time to regional progression; time to CNS progression; time to subsequent treatment; rate of radiation necrosis; rate of local recurrence; and rate of leptomeningeal disease.Trial registration numberNCT03750227 (Registration date: 21/11/2018).

Project description:Dairy products and impact exercise have previously been identified to be independently beneficial for bone mineral properties, however, it is unknown how the combination of these two osteogenic interventions may alter acute bone turnover. Using a randomized crossover design, we compared the acute effects of consuming milk vs. an isoenergetic carbohydrate control beverage on bone biomarkers following loading exercise. Thirteen healthy female participants (Age = 20.3 ± 2.3y; BMI = 21.0 ± 1.1 kg/m2) consumed either 550 mL of 0% skim white milk (MILK) or 52.7 g of maltodextrin in 550 mL of water (CHO), both 5 min and 1 h following completion of a combined plyometric (198 impacts) and resistance exercise (3-4 sets/exercise, 8-12 reps/set, ∼75% 1-RM) bout. Venous blood samples were obtained pre-exercise, and 15 min, 75 min, 24 h and 48 h post-exercise to assess serum concentrations of bone resorption biomarkers, specifically carboxyl-terminal crosslinking telopeptide of type I collagen (CTX), receptor activator nuclear factor kappa-β ligand (RANKL), and sclerostin (SOST), as well as bone formation biomarkers, specifically osteoprotegerin (OPG) and osteocalcin (OC). When absolute biomarker concentrations were examined, there were no interaction or group effects for any biomarker, however, there were main time effects (p < 0.05) for RANKL, SOST, and OC, which were lower, and the OPG: OPG/RANKL ratio, which was higher at 75 min post-exercise compared with baseline in both conditions. In addition to assessing absolute biomarker concentrations at specific timepoints, we also evaluated the relative (% change) cumulative post-exercise response (75 min to 48 h) using an area under the curve (AUC) analysis. This analysis showed that the relative post-exercise CTX response was significantly lower in the MILK compared to the CHO condition (p = 0.03), with no differences observed in the other biomarkers. These results show that while milk does not appear to alter absolute concentrations of bone biomarkers compared to CHO, it may attenuate relative post-exercise bone resorption (i.e., blunt the usual catabolic response to exercise).

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Influence of pre-operative oral carbohydrate loading vs. standard fasting on tumor proliferation and clinical outcome in breast cancer patients ? a randomized trial.

Publications

Influence of pre-operative oral carbohydrate loading vs. standard fasting on tumor proliferation and clinical outcome in breast cancer patients ─ a randomized trial.

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