Whey Protein Supplementation in Cancer Patients

NCT ID: NCT02065726

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-25

Study Completion Date

2018-06-30

Brief Summary

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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

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Conditions

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Solid Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Whey protein

Nutritional counseling + 20 g (2 x 10 g) of whey proteins (Prother® - Spepharm Italy)

Group Type EXPERIMENTAL

Whey protein

Intervention Type 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

Nutritional counseling

Nutritional counseling

Group Type ACTIVE_COMPARATOR

Nutritional counseling

Intervention Type OTHER

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Nutritional counseling

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

Intervention Type OTHER

Other Intervention Names

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Prother® (Spepharm Italy)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norgine

INDUSTRY

Sponsor Role collaborator

Akern Srl

INDUSTRY

Sponsor Role collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Emanuele Cereda

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emanuele Cereda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

1Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Riccardo Caccialanza, MD

Role: STUDY_DIRECTOR

1Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Locations

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

Pavia, Pavia, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 23845384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22345712 (View on PubMed)

Bounous G. Whey protein concentrate (WPC) and glutathione modulation in cancer treatment. Anticancer Res. 2000 Nov-Dec;20(6C):4785-92.

Reference Type BACKGROUND
PMID: 11205219 (View on PubMed)

Tozer RG, Tai P, Falconer W, Ducruet T, Karabadjian A, Bounous G, Molson JH, Droge W. Cysteine-rich protein reverses weight loss in lung cancer patients receiving chemotherapy or radiotherapy. Antioxid Redox Signal. 2008 Feb;10(2):395-402. doi: 10.1089/ars.2007.1919.

Reference Type BACKGROUND
PMID: 18158761 (View on PubMed)

Cereda E, Turri A, Klersy C, Cappello S, Ferrari A, Filippi AR, Brugnatelli S, Caraccia M, Chiellino S, Borioli V, Monaco T, Stella GM, Arcaini L, Benazzo M, Grugnetti G, Pedrazzoli P, Caccialanza R. Whey protein isolate supplementation improves body composition, muscle strength, and treatment tolerance in malnourished advanced cancer patients undergoing chemotherapy. Cancer Med. 2019 Nov;8(16):6923-6932. doi: 10.1002/cam4.2517. Epub 2019 Sep 30.

Reference Type DERIVED
PMID: 31568698 (View on PubMed)

Other Identifiers

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20130018046

Identifier Type: -

Identifier Source: org_study_id

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