A prospective pilot study to investigate the effect of protein supplement on skeletal muscle mass and rehabilitative outcome in brain tumor patient
- Conditions
- Neoplasms
- Registration Number
- KCT0009113
- Brief Summary
Baseline characteristics of the protein supplement (n=20) and control (n=24) groups were not different between groups (Table 1). The daily amount of protein consumed at baseline and protein consumption percentage relative to minimal requirements were not different between groups prior to the study. The compliance with protein supplement usage tended to be higher in the protein group than in the control group (p=0.052). After the 6-week intervention period, all patients of both groups showed improvements in the anthropometric measures. However, the change of anthropometric indices of BIA showed different patterns between groups. The skeletal muscle mass, fat-free mass tended to increase in both groups, however, the fat contents including body fat mass, fat mass index and body fat percentage tended to decrease in the protein group and increase in the control group. (Table 2). Laboratory results including the level of serum hemoglobin, protein, albumin, and CRP were also improved in all patients at follow-up. However, the improvements in hemoglobin, protein, albumin, and CRP were statistically significant only in the protein group (P<0.05). Functional assessments, MMSE, BBS, MBI, 6MWT, grip power, pinch power, and quadriceps muscle peak torque at 60 and 120 degrees were improved in all patients compared to the initial assessment. While most of the functional measures were improved in both groups compared with the baseline, 6MWT and pinch power were significantly improved only in the protein group (P<0.01) (Table 3). The state of malnutrition assessed by ASPEN guidelines showed a different tendency of change between groups after the protein supplementation. At follow-up, 65% (n=13) of malnutrition patients in the protein group decreased to 55% (n=11). Notably, the number of moderate malnutrition patients decreased from 4 to 2, and the resolution of malnutrition was observed only in the protein group. On the contrary, the overall number of malnutrition patients increased from 16 to 17 in the control group. The number of patients with no malnutrition only increased in the protein group (Fig. 1). In the sub-group analysis conducted according to ASPEN guidelines for classifying malnutrition, a significant difference was noted in the change of body composition, especially of fat-free mass and skeletal muscle mass after the intervention. The changes of skeletal muscle mass, body cell mass, and fat-free mass were significantly greater in the moderate malnutrition group than those with adequate nutrition in the protein group (P<0.05) (Table 4, Fig. 2). There was no significant change in the level of BUN, Creatinine, AST, ALT, and total cholesterol after the protein supplement. The protein supplement did not cause any gastrointestinal or alimentary side effects in need of medical attention except for a patient who withdrew participation due to abdominal discomfort after the protein supplement.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1. Patients who have voluntarily given written consent in the participant consent form prior to participating in this clinical trial.
2. Patients histologically diagnosed with a brain tumor (including both benign and malignant brain tumors such as meningioma and glioma).
3. Patients who have received surgery, chemotherapy, or radiation therapy for brain tumors in neurosurgery and have limitations in daily living activities and walking due to hemiplegia or quadriplegia.
4. Patients scheduled for inpatient rehabilitation treatment for more than 4 weeks at Severance Hospital Rehabilitation Hospital.
1. Individuals under 19 years of age or over 80 years of age.
2. Within the past 3 months prior to trial recruitment, having any of the following conditions: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke, or transient ischemic attack.
3. Individuals with an active infection or sepsis and undergoing antibiotic treatment.
4. Occurrence of deep vein thrombosis within 4 weeks prior to the start of trial recruitment.
5. Pregnant or nursing women. Positive pregnancy test results in women of childbearing potential.
6. Patients with liver dysfunction, acute and chronic hepatitis, or other liver function abnormalities, renal dysfunction, electrolyte imbalances requiring medication or fluid correction, or diagnosed with diabetes.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method muscle mass and rehabilitation improvement
- Secondary Outcome Measures
Name Time Method compliance