Solid Tumors Clinical Trial
Official title:
Whey Protein Supplementation in Malnourished Cancer Patients: a Randomized, Controlled Trial
NCT number | NCT02065726 |
Other study ID # | 20130018046 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 25, 2014 |
Est. completion date | June 2018 |
Verified date | June 2018 |
Source | IRCCS Policlinico S. Matteo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy | Pavia |
Lead Sponsor | Collaborator |
---|---|
IRCCS Policlinico S. Matteo | Akern Srl, Norgine |
Italy,
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
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 |
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