Whey Protein Supplementation in Cancer Patients

Not Applicable

Completed

• Conditions: Solid Tumors
• Interventions: Dietary Supplement: Whey protein; Other: Nutritional counseling

• Registration Number: NCT02065726
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-17
• Study First Submitted QC: 2014-02-17
• Study First Posted: 2014-02-19
• Study Start: 2014-02-25
• Status Verified: 2018-06
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whey protein	Whey protein	Nutritional counseling + 20 g (2 x 10 g) of whey proteins (Prother® - Spepharm Italy)
Nutritional counseling	Nutritional counseling	Nutritional counseling

Primary Outcome Measures

Name	Time	Method
Body composition	3 months	Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)

Secondary Outcome Measures

Name	Time	Method
Body composition	1 month	Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)
Body weight	3 months	Change in body weight during the study (at 1 month and 3 months)
Quality of life	3 months	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 \[EORTC QLQ-C30\]
Handgrip strength	3 months	Change in handgrip strength during the study (at 1 month and 3 months)

Trial Locations

Locations (1)

Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; 🇮🇹 Pavia, Italy