Clinical trial NCT02065726: Whey Protein Supplementation in Cancer Patients
Official title: Whey Protein Supplementation in Malnourished Cancer Patients: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Tumors
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: Norgine
name: Akern Srl
First posted: 2014-02-19
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body composition
timeFrame: 3 months
Secondary outcomes:
measure: Body composition
timeFrame: 1 month
measure: Body weight
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Handgrip strength
timeFrame: 3 months
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 3 months
Locations:
city: Pavia
country: Italy
facility: Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Study officials:
affiliation: 1Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
name: Emanuele Cereda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 1Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
name: Riccardo Caccialanza, MD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
citation: Bounous G. Whey protein concentrate (WPC) and glutathione modulation in cancer treatment. Anticancer Res. 2000 Nov-Dec;20(6C):4785-92.
citation: Tozer RG, Tai P, Falconer W, Ducruet T, Karabadjian A, Bounous G, Molson JH, Droge W. Cysteine-rich protein reverses weight loss in lung cancer patients receiving chemotherapy or radiotherapy. Antioxid Redox Signal. 2008 Feb;10(2):395-402. doi: 10.1089/ars.2007.1919.
citation: Cereda E, Turri A, Klersy C, Cappello S, Ferrari A, Filippi AR, Brugnatelli S, Caraccia M, Chiellino S, Borioli V, Monaco T, Stella GM, Arcaini L, Benazzo M, Grugnetti G, Pedrazzoli P, Caccialanza R. Whey protein isolate supplementation improves body composition, muscle strength, and treatment tolerance in malnourished advanced cancer patients undergoing chemotherapy. Cancer Med. 2019 Nov;8(16):6923-6932. doi: 10.1002/cam4.2517. Epub 2019 Sep 30.