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Whey Protein Supplementation in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02065726
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
Norgine
Akern Srl
Information provided by (Responsible Party):
Emanuele Cereda, IRCCS Policlinico S. Matteo

Tracking Information
First Submitted Date  ICMJE February 17, 2014
First Posted Date  ICMJE February 19, 2014
Last Update Posted Date June 8, 2018
Actual Study Start Date  ICMJE February 25, 2014
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2014)
Body composition [ Time Frame: 3 months ]
Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02065726 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2014)
  • Body composition [ Time Frame: 1 month ]
    Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)
  • Body weight [ Time Frame: 3 months ]
    Change in body weight during the study (at 1 month and 3 months)
  • Quality of life [ Time Frame: 3 months ]
    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]
  • Handgrip strength [ Time Frame: 3 months ]
    Change in handgrip strength during the study (at 1 month and 3 months)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE
 (submitted: June 6, 2018)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 3 months ]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Whey Protein Supplementation in Cancer Patients
Official Title  ICMJE Whey Protein Supplementation in Malnourished Cancer Patients: a Randomized, Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE
  • 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 Name: Prother® (Spepharm Italy)
  • Other: Nutritional counseling
    Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician
Study Arms
  • Experimental: Whey protein
    Nutritional counseling + 20 g (2 x 10 g) of whey proteins (Prother® - Spepharm Italy)
    Intervention: Dietary Supplement: Whey protein
  • Active Comparator: Nutritional counseling
    Nutritional counseling
    Intervention: Other: Nutritional counseling
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2018)
166
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2014)
192
Actual Study Completion Date June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02065726
Other Study ID Numbers  ICMJE 20130018046
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Emanuele Cereda, IRCCS Policlinico S. Matteo
Study Sponsor  ICMJE IRCCS Policlinico S. Matteo
Collaborators  ICMJE
  • Norgine
  • Akern Srl
Investigators  ICMJE
Principal Investigator: Emanuele Cereda, MD, PhD 1Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Study Director: Riccardo Caccialanza, MD 1Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
PRS Account IRCCS Policlinico S. Matteo
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP