Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis

NCT02055534 | Completed DMC

• 1 other identifier: PVSMATT01 - amyloid nutr
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Poor nutritional status is common in patients with systemic immunoglobulin light-chain (AL) amyloidosis and has been associated with mortality and impaired quality of life (QoL). We investigated whether nutritional counseling is beneficial to the maintenance of nutritional status and QoL in AL outpatients.

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Body weight

  Change in body weight at 12 months

  12 months

Secondary Outcomes (2)

• Quality of life

  12 months

• Overall survival

  12 months

Study Arms (2)

Nutritional counseling

EXPERIMENTAL

Nutritional counseling consists in: personalized dietary prescription associated with regular (every 3 weeks) dietetic advise by a registered dietician. Follow-up evaluations take place also during the visits scheduled by the Amyloidosis Center

Other: Nutritional counseling

General dietary advices

OTHER

General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the Amyloidosis Center

Other: General dietary advices

Interventions

Nutritional counseling OTHER

Nutritional counseling consists in: personalized dietary prescription associated with regular (every 3 weeks) dietetic advise by a registered dietician. Follow-up evaluations take place also during the visits scheduled by the oncologists

Nutritional counseling

General dietary advices OTHER

General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the oncologists

General dietary advices

Eligibility Criteria

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

You may qualify if:

• Treatment naïve patients with with systemic immunoglobulin light-chain amyloidosis
• Availability to planned measurements and to written informed consent

You may not qualify if:

• Age \< 18 years
• Indication to organ transplantation
• Indication to autologous stem cell transplantation
• Need to start or ongoing dialysis
• Ascites or massive edema
• Need to start or ongoing artificial nutrition

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (5)

• Caccialanza R, Palladini G, Klersy C, Cereda E, Bonardi C, Cameletti B, Quarleri L, Montagna E, Foli A, Milani P, Lavatelli F, Marena C, Merlini G. Malnutrition at diagnosis predicts mortality in patients with systemic immunoglobulin light-chain amyloidosis independently of cardiac stage and response to treatment. JPEN J Parenter Enteral Nutr. 2014 Sep;38(7):891-4. doi: 10.1177/0148607113501328. Epub 2013 Sep 26.

  PMID: 24072737 BACKGROUND

• Caccialanza R, Palladini G, Klersy C, Cereda E, Bonardi C, Cameletti B, Montagna E, Russo P, Foli A, Milani P, Lavatelli F, Merlini G. Nutritional status independently affects quality of life of patients with systemic immunoglobulin light-chain (AL) amyloidosis. Ann Hematol. 2012 Mar;91(3):399-406. doi: 10.1007/s00277-011-1309-x. Epub 2011 Aug 9.

  PMID: 21826471 BACKGROUND

• Caccialanza R, Palladini G, Klersy C, Cena H, Vagia C, Cameletti B, Russo P, Lavatelli F, Merlini G. Nutritional status of outpatients with systemic immunoglobulin light-chain amyloidosis 1. Am J Clin Nutr. 2006 Feb;83(2):350-4. doi: 10.1093/ajcn/83.2.350.

  PMID: 16469994 BACKGROUND

• Sattianayagam PT, Lane T, Fox Z, Petrie A, Gibbs SD, Pinney JH, Risom SS, Rowczenio DM, Wechalekar AD, Lachmann HJ, Gilbertson JA, Hawkins PN, Gillmore JD. A prospective study of nutritional status in immunoglobulin light chain amyloidosis. Haematologica. 2013 Jan;98(1):136-40. doi: 10.3324/haematol.2012.070359. Epub 2012 Sep 14.

  PMID: 22983575 BACKGROUND

• Caccialanza R, Palladini G, Cereda E, Bonardi C, Milani P, Cameletti B, Quarleri L, Cappello S, Foli A, Lavatelli F, Klersy C, Merlini G. Nutritional counseling improves quality of life and preserves body weight in systemic immunoglobulin light-chain (AL) amyloidosis. Nutrition. 2015 Oct;31(10):1228-34. doi: 10.1016/j.nut.2015.04.011. Epub 2015 May 11.

  PMID: 26250487 DERIVED

MeSH Terms

Conditions

Amyloidosis

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

• Riccardo Caccialanza, MD

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

  PRINCIPAL INVESTIGATOR

• Giampaolo Merlini, MD

  Amyloidosis Research and Treatment Center, Biotechnology Research Laboratories, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Italy

  STUDY CHAIR

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: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: July 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 1, 2025

Record last verified: 2014-02

Locations

IT (1)