An interventional study of Whey protein and Nutritional counseling in Solid Tumors, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Not applicable, Interventional, and Treatment
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.
Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nutritional counseling + 20 g (2 x 10 g) of whey proteins (Prother® - Spepharm Italy)
Dietary Supplement: Whey protein
Nutritional counseling
Other: Nutritional counseling
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
Also known as: Prother® (Spepharm Italy)
Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician
Body composition
Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)
Time frame: 3 months
Body composition
Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)
Time frame: 1 month
Body weight
Change in body weight during the study (at 1 month and 3 months)
Time frame: 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 \[EORTC QLQ-C30\]
Time frame: 3 months
Handgrip strength
Change in handgrip strength during the study (at 1 month and 3 months)
Time frame: 3 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 3 months
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Policlinico San Matteo di Pavia