Whey Protein Supplementation in Cancer Patients

June 6, 2018 updated by: Emanuele Cereda, IRCCS Policlinico S. Matteo

Whey Protein Supplementation in Malnourished Cancer Patients: a Randomized, Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Prother® (Spepharm Italy)
Active Comparator: Nutritional counseling
Other: Nutritional counseling
Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 3 months
Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 1 month
Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)
1 month
Body weight
Time Frame: 3 months
Change in body weight during the study (at 1 month and 3 months)
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]
3 months
Handgrip strength
Time Frame: 3 months
Change in handgrip strength during the study (at 1 month and 3 months)
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Matteo

Collaborators

Norgine
Akern Srl

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2014

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

February 17, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

June 8, 2018

Last Update Submitted That Met QC Criteria

June 6, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 20130018046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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