Amyloidosis
Conditions
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.
Interventions
OTHERNutritional 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 are provided. Follow-up evaluations take place during the visits scheduled by the oncologists
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 12 months | Change in body weight at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 12 months | Change in quality of life at 12 months |
| Overall survival | 12 months | Overall survival at the end of study |
Countries
Italy
Outcome results
None listed