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Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis

Primary Purpose

Amyloidosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Nutritional counseling
General dietary advices
Sponsored by
IRCCS Policlinico S. Matteo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione IRCCS Policlinico San Matteo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Nutritional counseling

General dietary advices

Arm Description

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

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

Outcomes

Primary Outcome Measures

Body weight
Change in body weight at 12 months

Secondary Outcome Measures

Quality of life
Change in quality of life at 12 months
Overall survival
Overall survival at the end of study

Full Information

First Posted
February 4, 2014
Last Updated
February 6, 2014
Sponsor
IRCCS Policlinico S. Matteo
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1. Study Identification

Unique Protocol Identification Number
NCT02055534
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutritional counseling
Arm Type
Experimental
Arm Description
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
Arm Title
General dietary advices
Arm Type
Other
Arm Description
General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the Amyloidosis Center
Intervention Type
Other
Intervention Name(s)
Nutritional counseling
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
General dietary advices
Intervention Description
General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the oncologists
Primary Outcome Measure Information:
Title
Body weight
Description
Change in body weight at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
Change in quality of life at 12 months
Time Frame
12 months
Title
Overall survival
Description
Overall survival at the end of study
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riccardo Caccialanza, MD
Organizational Affiliation
Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giampaolo Merlini, MD
Organizational Affiliation
Amyloidosis Research and Treatment Center, Biotechnology Research Laboratories, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24072737
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.
Results Reference
background
PubMed Identifier
21826471
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.
Results Reference
background
PubMed Identifier
16469994
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.
Results Reference
background
PubMed Identifier
22983575
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.
Results Reference
background
PubMed Identifier
26250487
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.
Results Reference
derived

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Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis

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