Solid Tumors
Conditions
Brief summary
Nutritional derangements are very common in cancer patients and negatively affect survival, morbidity and quality of life. Intervention trials have demonstrated that nutritional counseling can improve energy balance, nutritional status and quality of life in patients undergoing chemo-radiotherapy. Oxidative stress plays a role in the tumor-cytotoxic effect of cancer chemotherapy and radiotherapy but may also play a role therapy-related adverse events such as an impairment of nutritional status and quality of life. The nutritional properties of whey protein have recently raised attention. In view of the high content in cysteine these proteins can positively stimulate the synthesis of glutathione which, in turn, could contribute to the modulation of whole-body and cellular redox state. However, evidence on the role of this dietary intervention in cancer patients is limited.
Interventions
OTHERNutritional counseling
Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician
DIETARY_SUPPLEMENTWhey protein
Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician + 20 g (2 x 10 g) of whey proteins
Sponsors
Norgine
Akern Srl
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
* Cancer patients (lung, gastric, pancreatic, breast, colon, esophageal) * Eastern Cooperative Oncology Group performance status ≤ 2 * Weight loss \>= 10% in the last 6 months * Chemotherapy * Written informed consent
Exclusion criteria
* Age \< 18 years * Ongoing artificial nutrition (enteral or parenteral) * Unavailability to planned measurements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 3 months | Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 1 month | Change in phase angle assessed by bioelectrical impedance vectorial analysis (BIVA) |
| Body weight | 3 months | Change in body weight during the study (at 1 month and 3 months) |
| Quality of life | 3 months | Change in quality of life during the study (at 1 month and 3 months) as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 \[EORTC QLQ-C30\] |
| Handgrip strength | 3 months | Change in handgrip strength during the study (at 1 month and 3 months) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 3 months | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
Italy
Outcome results
None listed