Whey Protein Supplementation in Cancer Patients

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065726
• Other study ID #: 20130018046
• Status: Completed
• Phase: N/A
• Start date: February 25, 2014
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Dietary Supplement:
• Whey protein
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

Other:
• Nutritional counseling
Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician

Locations

Country	Name	City	State
Italy	Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy	Pavia

Sponsors (3)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo	Akern Srl, Norgine

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Baldwin C, Spiro A, Ahern R, Emery PW. Oral nutritional interventions in malnourished patients with cancer: a systematic review and meta-analysis. J Natl Cancer Inst. 2012 Mar 7;104(5):371-85. doi: 10.1093/jnci/djr556. Epub 2012 Feb 15. Review. — View Citation

Bounous G. Whey protein concentrate (WPC) and glutathione modulation in cancer treatment. Anticancer Res. 2000 Nov-Dec;20(6C):4785-92. Review. — View Citation

Langius JA, Zandbergen MC, Eerenstein SE, van Tulder MW, Leemans CR, Kramer MH, Weijs PJ. Effect of nutritional interventions on nutritional status, quality of life and mortality in patients with head and neck cancer receiving (chemo)radiotherapy: a systematic review. Clin Nutr. 2013 Oct;32(5):671-8. doi: 10.1016/j.clnu.2013.06.012. Epub 2013 Jun 26. Review. — View Citation

Tozer RG, Tai P, Falconer W, Ducruet T, Karabadjian A, Bounous G, Molson JH, Dröge W. Cysteine-rich protein reverses weight loss in lung cancer patients receiving chemotherapy or radiotherapy. Antioxid Redox Signal. 2008 Feb;10(2):395-402. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	3 months
Primary	Body composition	Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)	3 months
Secondary	Body composition	Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)	1 month
Secondary	Body weight	Change in body weight during the study (at 1 month and 3 months)	3 months
Secondary	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
Secondary	Handgrip strength	Change in handgrip strength during the study (at 1 month and 3 months)	3 months