Clinical trial NCT02055534: Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis
Official title: Nutritional Counseling in Systemic Immunoglobulin Light-chain (AL) Amyloidosis: a Prospective Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyloidosis
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Body weight
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life
timeFrame: 12 months
measure: Overall survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
affiliation: Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Italy
name: Riccardo Caccialanza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amyloidosis Research and Treatment Center, Biotechnology Research Laboratories, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Italy
name: Giampaolo Merlini, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.