The effect of nutritional counseling on muscle mass and treatment outcome in patients with metastatic colorectal cancer undergoing chemotherapy: A randomized controlled trial.

BACKGROUND & AIMS: A low muscle mass before start of treatment and loss of muscle mass during chemotherapy is related to adverse outcomes in patients with cancer. In this randomized controlled trial, the effect of nutritional counseling on change in muscle mass and treatment outcome in patients with metastatic colorectal cancer during first-line chemotherapy was studied. METHODS: Patients scheduled for first-line chemotherapy (n = 107) were randomly assigned to individualized nutritional counseling by a dietitian (NC) or usual care (UC). NC was aimed at sufficient protein- and energy intake, supported by oral supplements or enteral feeding if indicated. Furthermore, physical activity was encouraged. Outcomes were assessed at baseline (T0) and the time of the first (T1) and second (T2) regular follow-up computed tomography scans. The proportion of patients with a clinically relevant decrease in skeletal muscle area of ≥6.0 cm2, measured by computed tomography, was the primary outcome. Secondary outcomes included body weight, quality of life, treatment toxicity and progression free and overall survival. RESULTS: A total of 107 patients were enrolled (mean age, 65 years (SD, 11 years), 63% male). Mean change in skeletal muscle area from T0 till T1 was -2.5 (SD, 9.5) cm2, with no difference between NC versus UC (p = 0.891). The proportion of patients with a clinically relevant decrease in skeletal muscle area of ≥6.0 cm2 did not differ (NC 30% versus UC 31%, p = 0.467). NC compared with UC had a significant positive effect on body weight (B coefficient 1.7, p = 0.045), progression free survival (p = 0.039) and overall survival (p = 0.046). CONCLUSIONS: NC of patients undergoing chemotherapy for metastatic colorectal cancer had no effect on muscle mass. However, we found that NC may increase body weight and improve progression free survival and overall survival compared to UC in this group of patients. These findings need further evaluation in future clinical trials. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov NCT01998152; Netherlands Trial Register NTR4223.

Nimodipine treatment of ischemic neurological deficits due to cerebral vasospasm after subarachnoid hemorrhage. Clinical results of a multicenter study.

Intravenous Nimodipine was administered to 109 patients (65 female and 44 male) with either pre- or post-operative progressive neurological deterioration from cerebral vasospasm following subarachnoid hemorrhage from a ruptured aneurysm. In 91 of the patients the efficacy of Nimodipine in relieving ischemic symptoms was assessed and in all of the 109 patients the tolerance was evaluated. The aneurysms were related to following arteries: anterior communicating artery (41%), middle cerebral artery (24%), internal carotid artery (10%), vertebro-basilar arteries (4%) and others (5.5%); 11% of the patients had multiple aneurysms. On 16 of the 91 patients no surgery was performed. On 16% of the remaining 75 patients surgery was performed within 72 hours after the hemorrhage, 57% were operated between day 4 and day 15 and 29% after day 16. The ischemic neurological deficits occurred preoperatively in 67% of the patients and post-operatively in 23%. At the beginning of treatment 84% of the patients were graded III-V according to the Hunt and Hess grading system. Most of the patients received doses of 24-48 mg Nimodipine daily as constant i.v. infusion for 7-10 days. The grade of neurological deficit at the end of the treatment was evaluated according to the Glasgow Outcome Scale. 59 (65%) of the patients showed complete recovery or marked improvement of the ischemic symptoms while 22% remained unchanged and 11% died due to severe vasospasm. Administration of Nimodipine seemed to be more efficient in cases where treatment was started within 24 hours. In the patient group which was treated pre-operatively, recurrent hemorrhage was recorded in 8% of the patients.(ABSTRACT TRUNCATED AT 250 WORDS)