Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
166 participants
INTERVENTIONAL
2014-02-25
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Whey protein
Nutritional counseling + 20 g (2 x 10 g) of whey proteins (Prother® - Spepharm Italy)
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
Nutritional counseling
Nutritional counseling
Nutritional counseling
Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician
Interventions
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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
Nutritional counseling
Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group performance status ≤ 2
* Weight loss \>= 10% in the last 6 months
* Chemotherapy
* Written informed consent
Exclusion Criteria
* Ongoing artificial nutrition (enteral or parenteral)
* Unavailability to planned measurements
18 Years
ALL
No
Sponsors
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Norgine
INDUSTRY
Akern Srl
INDUSTRY
Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Responsible Party
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Emanuele Cereda
Physician
Principal Investigators
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Emanuele Cereda, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
1Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Riccardo Caccialanza, MD
Role: STUDY_DIRECTOR
1Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Locations
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Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Pavia, Pavia, Italy
Countries
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References
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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.
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.
Bounous G. Whey protein concentrate (WPC) and glutathione modulation in cancer treatment. Anticancer Res. 2000 Nov-Dec;20(6C):4785-92.
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.
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.
Other Identifiers
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20130018046
Identifier Type: -
Identifier Source: org_study_id
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