Nutritional Supplementation in Patients With no Signs of Malnutrition

The Effect of Nutritional Supplementation in Cancer Patients With no Clinical Signs of Malnutrition

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01894828

Enrollment

200

Registered

2013-07-10

Start date

2011-04-30

Completion date

Unknown

Last updated

2013-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Neoplasm, Primary Neoplasm, Secondary Neoplasm

Keywords

Nutritional support, Gastrointestinal cancer, Malnutrition

Brief summary

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

Detailed 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

Interventions

DIETARY_SUPPLEMENTNutritional supplements

Patients are asked to drink two 200ml bottles of nutritional supplement daily for 14 days before surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement of nutritional status	After 14 days	The aim of the study was to assess if nutritional supplementation improves nutritional status of patients with no clinical signs of malnutrition. Nutritional status improvement will be assessed by change in anthropometric (body weight (kg)) and laboratory (albumin, total protein, transferrin level, total lymphocyte count) parameters.

Secondary

Measure	Time frame	Description
Reducing number of complications	30 days after surgery	To assess if improvement of nutritional status is connected with reduced number of postoperative complications.

Countries

Poland

Contacts

Primary ContactPaweł Kabata, MD

pawel.kabata@gmail.com+48509707959

Backup ContactTomasz Jastrzębski, Prof

jasek@post.pl+48583493190

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026