Clinical Impact of Highly Purified, Whey Proteins in Patients Affected With Colorectal Cancer Undergoing Chemotherapy: Preliminary Results of a Placebo-Controlled Study

Abstract

Background and Aims: Sarcopenia, the loss of both lean body and skeletal muscle mass, may interfere in cancer patients outcome. As investigated, whey proteins could prevent the onset of sarcopenia. We have conducted a study to evaluate the effects of whey protein in colorectal cancer patients, undergoing 5-fluorouracil-based chemotherapy. Methods: After written informed consent, patients were blind randomized 1:1 to whey protein (ProLYOtin; arm A) versus placebo (arm B). The patients were assessed both physically and nutritionally before chemotherapy and after 3 (T2) and 6 months (T3) by body impedance assessment, L3-computed tomography scan, Mini Nutritional Assessment (MNA), and Malnutrition Universal Screening Tool (MUST) tests. Results: Forty-seven patients were included in this preliminary analysis. Baseline characteristics were well balanced between the 2 arms. During chemotherapy, 33 patients were reevaluated: anthropometric parameters (lean body mass from 68.5% to 71.2% vs 68.7% to 66.3%, and sarcopenia from 84% to 54% and 83% to 77% from baseline to T2 evaluation in arms A and B, respectively), nutritional status (MNA >24 = 100% [A] vs 73.7% [B]), and toxicity (no adverse effects in 86% [A] vs 29% [B] and 94% [A] vs 29% [B] for hematological and gastrointestinal toxicities, respectively) resulted to be significantly different. At univariate analysis, a condition of malnutrition risk according to MUST (relative risk [RR] = 7.5, P = .02) or MNA (RR = 1.45, P = .02) and ProLYOtin intake (RR = 0.12, P = .01) were found to be significantly predictive of chemotherapy toxicity. Conclusions: At present, our study shows how whey protein could be an important therapeutic option to improve nutritional status, and particularly to prevent severe toxicity during chemotherapy.

Keywords: adjuvant chemotherapy; colorectal cancer; malnutrition; protein supplementation; sarcopenia; toxicity; whey protein.

Figure 1.

CONSORT flow chart.

Figure 2.

Mini Nutritional Assessment (MNA) differences between 2 treatment arms at baseline (T1), and after 3 (T2) and 6 (T3) months.

Figure 3.

Malnutrition Universal Screening Tool (MUST) differences between 2 treatment arms at baseline (T1) and after 3 (T2) and 6 (T3) months.

Figure 4.

Body mass index differences between 2 treatment arms at baseline (T1) and after 3 (T2) and 6 (T3) months.

Figure 5.

Bioelectrical impedance analysis differences between 2 treatment arms at baseline (T1) and after 3 (T2) and 6 (T3) months.

Figure 6.

Sarcopenia evaluation by TC-L3 at baseline (T1) and after 3 (T2) and 6 (T3) months.

Figure 7.

(a) Significant hematological toxicity differences between treatment arms. (b) Significant gastrointestinal toxicity differences between treatment arms.