Nutritional Supplementation in Patients With no Signs of Malnutrition

MedSource

Status and phase: Unknown; Phase 4

Conditions: Abdominal Neoplasm; Primary Neoplasm; Secondary Neoplasm

Treatments: Dietary Supplement: Nutritional supplements

Study type: Interventional

Funder types: Industry

Identifiers

NCT01894828

Nutri01

Details and patient eligibility

About

The aim of the study was to assess the effect of nutritional supplementation on nutritional status and postoperational complications in cancer patients with no clinical signs of malnutrition

Full description

In previous psychological studies our team found high level psychological stress in over 60% of cancer patients. This may cause numerous problems including anorexia, which together with biological disturbances can initiate cancer related catabolism even when it can not yet be seen. In this study we want to answer the question if oral nutritional supplementation can help the patient overcome the catabolism in its initial phase and improve nutritional status, which would result in reduced number of postoperational complications

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary or secondary resectable gastrointestinal and abdominal malignancy
• No signs of malnutrition at qualification for surgery
• General performance >70 Karnofsky scale
• Informed consent

Exclusion criteria

• history of radio or chemotherapy
• signs of mechanical ileus
• other major gastrointestinal diseases
• type 1 diabetes
• autoimmunological diseases requiring systemic steroids
• signs of infection
• renal and/or liver failure

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Nutritional supplements

Active Comparator group

Description:

Patients are asked to drink two 200ml bottles of nutritional supplement daily

Treatment:

Dietary Supplement: Nutritional supplements

Control

No Intervention group

Description:

Patients are asked to keep on to their normal diet. No supplementation is introduced