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| Name | Class |
|---|---|
| Norgine | INDUSTRY |
| Akern Srl | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein | Experimental | Nutritional counseling + 20 g (2 x 10 g) of whey proteins (ProtherĀ® - Spepharm Italy) |
|
| Nutritional counseling | Active Comparator | Nutritional counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA) | 1 month |
| Body weight | Change in body weight during the study (at 1 month and 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emanuele Cereda, MD, PhD | 1Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy | Principal Investigator |
| Riccardo Caccialanza, MD | 1Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy | Pavia | Pavia | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23845384 | Background | 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. | |
| 22345712 |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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|
| Nutritional counseling | Other | Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician |
|
| 3 months |
| 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 |
| Handgrip strength | Change in handgrip strength during the study (at 1 month and 3 months) | 3 months |
| 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. |
| 11205219 | Background | Bounous G. Whey protein concentrate (WPC) and glutathione modulation in cancer treatment. Anticancer Res. 2000 Nov-Dec;20(6C):4785-92. |
| 18158761 | Background | 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. |
| 31568698 | Derived | 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. |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |