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Completed

NCT Number: NCT02065726

Whey Protein Supplementation in Cancer Patients

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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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Prother® (Spepharm Italy)

nutritional counseling

Other

Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician

Primary outcomes

  1. Body composition

    Time frame: 3 months

    Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA)

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • Akern Srl
  • Norgine

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2014
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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