Whey Protein Supplementation in Cancer Patients

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Solid Tumors

Treatments: Dietary Supplement: Whey protein; Other: Nutritional counseling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02065726

20130018046

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

Whey protein

Experimental group

Description:

Nutritional counseling + 20 g (2 x 10 g) of whey proteins (Prother® - Spepharm Italy)

Treatment:

Dietary Supplement: Whey protein

Nutritional counseling

Active Comparator group

Description:

Nutritional counseling

Treatment:

Other: Nutritional counseling