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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumors Dietary Supplement: Whey protein Other: Nutritional counseling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Whey Protein Supplementation in Malnourished Cancer Patients: a Randomized, Controlled Trial
Actual Study Start Date : February 25, 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Whey protein
Nutritional counseling + 20 g (2 x 10 g) of whey proteins (Prother® - Spepharm Italy)
 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)
Active Comparator: Nutritional counseling
Nutritional counseling
 Other: Nutritional counseling
Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician


Outcome Measures
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Primary Outcome Measures :
  1. Body composition [ Time Frame: 3 months ]
    Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)


Secondary Outcome Measures :
  1. Body composition [ Time Frame: 1 month ]
    Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)

  2. Body weight [ Time Frame: 3 months ]
    Change in body weight during the study (at 1 month and 3 months)

  3. 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]

  4. Handgrip strength [ Time Frame: 3 months ]
    Change in handgrip strength during the study (at 1 month and 3 months)


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065726


Locations
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Italy
Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Norgine
Akern Srl
Investigators
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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
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Emanuele Cereda, Physician, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT02065726    
Other Study ID Numbers: 20130018046
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018