Whey Protein Supplementation in Cancer Patients

NCT02065726 | Completed DMC

• 1 other identifier: 20130018046
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Body composition

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

  3 months

Secondary Outcomes (4)

• Body composition

  1 month

• Body weight

  3 months

• Quality of life

  3 months

• Handgrip strength

  3 months

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  3 months

Study Arms (2)

Whey protein

EXPERIMENTAL

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

Dietary Supplement: Whey protein

Nutritional counseling

ACTIVE COMPARATOR

Nutritional counseling

Other: Nutritional counseling

Interventions

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

Also known as: Prother® (Spepharm Italy)

Whey protein

Nutritional counseling OTHER

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

Nutritional counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Ongoing artificial nutrition (enteral or parenteral)
• Unavailability to planned measurements

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• Norgine: collaborator
• Akern Srl: collaborator

Study Sites (1)

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

Pavia, Pavia, 27100, Italy

Location

Related Publications (5)

• 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.

  PMID: 23845384 BACKGROUND

• 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.

  PMID: 22345712 BACKGROUND

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

  PMID: 11205219 BACKGROUND

• 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.

  PMID: 18158761 BACKGROUND

• 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.

  PMID: 31568698 DERIVED

MeSH Terms

Interventions

Whey Proteins; Nutrition Assessment

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Emanuele Cereda, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Riccardo Caccialanza, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 19, 2014
• Study Start: February 25, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 1, 2025

Record last verified: 2018-06

Locations

IT (1)