Whey Protein Supplementation in Cancer Patients

Study Overview
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Brief Summary
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Nutritional derangements are very common in cancer patients and negatively affect survival, morbidity and quality of life. Intervention trials have demonstrated that nutritional counseling can improve energy balance, nutritional status and quality of life in patients undergoing chemo-radiotherapy. Oxidative stress plays a role in the tumor-cytotoxic effect of cancer chemotherapy and radiotherapy but may also play a role therapy-related adverse events such as an impairment of nutritional status and quality of life. The nutritional properties of whey protein have recently raised attention. In view of the high content in cysteine these proteins can positively stimulate the synthesis of glutathione which, in turn, could contribute to the modulation of whole-body and cellular redox state. However, evidence on the role of this dietary intervention in cancer patients is limited.

Official Title
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Whey Protein Supplementation in Malnourished Cancer Patients: a Randomized, Controlled Trial

Conditions
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Solid Tumors

Intervention / Treatment
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* Dietary Supplement: Whey protein
* Other: Nutritional counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer patients (lung, gastric, pancreatic, breast, colon, esophageal) Eastern Cooperative Oncology Group performance status ≤ 2 Weight loss >= 10% in the last 6 months Chemotherapy Written informed consent Exclusion Criteria: Age < 18 years Ongoing artificial nutrition (enteral or parenteral) Unavailability to planned measurements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey protein<br>Nutritional counseling + 20 g (2 x 10 g) of whey proteins (Prother® - Spepharm Italy) | Dietary Supplement: Whey protein<br>* Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician + 20 g (2 x 10 g) of whey proteins<br>* Other names: Prother® (Spepharm Italy);|
| Active Comparator: Nutritional counseling<br>Nutritional counseling | Other: Nutritional counseling<br>* Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA) | 1 month | 
| Body weight | Change in body weight during the study (at 1 month and 3 months) | 3 months | 
| Quality of life | Change in quality of life during the study (at 1 month and 3 months) as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 [EORTC QLQ-C30] | 3 months | 
| Handgrip strength | Change in handgrip strength during the study (at 1 month and 3 months) | 3 months |