AmyloidosisNCT02055534
Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis
A study testing Nutritional counseling and General dietary advices in people with Amyloidosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis
- What is being tested?
- Nutritional counseling and General dietary advices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2007to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment naïve patients with with systemic immunoglobulin light-chain amyloidosis
- Availability to planned measurements and to written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Counseling in Systemic Immunoglobulin Light-chain (AL) Amyloidosis: a Prospective Randomized, Controlled Trial.
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
- Being tested
- Nutritional counseling, General dietary advices
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional counselingOther
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 advicesOther
General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the oncologists
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: General dietary advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Change in body weight at 12 months
Measured: 12 months
Secondary outcomes (2)
Quality of life
Change in quality of life at 12 months
Measured: 12 months
Overall survival
Overall survival at the end of study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startJul 2007
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Caccialanza, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Riccardo Caccialanza, MD, Principal investigator, Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, ItalyGiampaolo Merlini, MD, Study chair, Amyloidosis Research and Treatment Center, Biotechnology Research Laboratories, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055534
- Sponsor's protocol ID
- PVSMATT01 - amyloid nutr
- Status last verified
- Feb 2014
- First submitted
- 4 Feb 2014
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24072737Caccialanza 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.
PubMed 21826471Caccialanza 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.
PubMed 16469994Sattianayagam 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.
PubMed 22983575Caccialanza 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.
PubMed 26250487
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Counseling in Systemic Immunoglobulin Light-chain (AL) Amyloidosis: a Prospective Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT02055534
- Acronym / sponsor ID
- PVSMATT01 - amyloid nutr
- Conditions
- Amyloidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional counseling | Experimental | Other: Nutritional counselingNutritional 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 | Other | Other: General dietary advicesGeneral dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the Amyloidosis Center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Treatment naïve patients with with systemic immunoglobulin light-chain amyloidosis
- Availability to planned measurements and to written informed consent
Key exclusion criteria (6 listed)
- Age < 18 years
- Indication to organ transplantation
- Indication to autologous stem cell transplantation
- Need to start or ongoing dialysis
- Ascites or massive edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional counselingNutritional 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 | Other | Nutritional counseling |
| General dietary advicesGeneral dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the oncologists | Other | General dietary advices |
Primary outcome
Body weight
Time frame: 12 months
Change in body weight at 12 months
2 secondary outcomes
Quality of life
Time frame: 12 months
Overall survival
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Background: PubMed 24072737Caccialanza 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.
- Background: PubMed 21826471Caccialanza 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.
- Background: PubMed 16469994Caccialanza 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.
- Background: PubMed 22983575Sattianayagam 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.
- Derived from this study: PubMed 26250487Caccialanza 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riccardo Caccialanza, MD principal investigator
Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Italy
Giampaolo Merlini, MD study chair
Amyloidosis Research and Treatment Center, Biotechnology Research Laboratories, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional counseling and General dietary advices in people with Amyloidosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02055534, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.