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NCT02055534 Clinical Trial

Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis

Amyloidosis Clinical Trial

Official title:
Nutritional Counseling in Systemic Immunoglobulin Light-chain (AL) Amyloidosis: a Prospective Randomized, Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02055534
Other study ID # PVSMATT01 - amyloid nutr
Secondary ID
Status Completed
Phase N/A
First received February 4, 2014
Last updated February 6, 2014
Start date July 2007
Est. completion date September 2013

Study information
Verified date February 2014
Source IRCCS Policlinico S. Matteo
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 144
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Nutritional counseling
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
• General dietary advices
General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the oncologists

Locations
Country Name City State
Italy Fondazione IRCCS Policlinico San Matteo Pavia

Sponsors (1)
Lead Sponsor Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Body weight Change in body weight at 12 months 12 months No
Secondary Quality of life Change in quality of life at 12 months 12 months No
Secondary Overall survival Overall survival at the end of study 12 months No
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