NCT03863236

A Study of Perioperative Oral Nutritional Support for Patients Having Surgery for Colon Cancer, Peri-Nutri

Status unknown NA Last updated 18 May 2022

What this trial tests

NA trial testing regular diet in Colon Cancer in 318 participants. Status unknown.

Timeline

1 April 2019

Primary endpoint
1 April 2026

1 April 2026

Quick facts

Lead sponsor	University of Oulu
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	318
Start date	1 April 2019
Primary completion	1 April 2026
Estimated completion	1 April 2026
Sites	1 location across Finland

Drugs / interventions tested

• regular diet
• nutritional support Resource 2.5

Conditions studied

• Colon Cancer — all drugs for Colon Cancer →
• Sarcopenia — all drugs for Sarcopenia →

Sponsor

University of Oulu

Who can join

18 and older, any sex, with Colon Cancer or Sarcopenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, unblinded, randomized study. The aim of this study is to research whether preoperative and postoperative oral nutritional supplement (ONS) (Resource 2.5 Compact/fibre compact) used at least 2 weeks prior the surgery and 10 days after surgery can improve the nutritional status of a colon cancer patient and reduce number of complications. The aim is also to investigate whether the oral nutritional support can shorten the hospital stay and improve the patients´ quality of life. The aim is also to find out whether the oral nutritional support can reduce 90-day mortality and improve disease free and overall survival.

Consecutive patients diagnosed with primary adenocarcinoma of the colon who are considered for radical surgical procedure are enrolled in this study provided that the inclusion criteria are filled.

Patients in the intervention group start oral nutritional support (ONS)2 portions a day for about 2 weeks prior to the operation starting at the time of randomization and continue ONS 10 days after the operation. Control group will continue with their regular diet without ONS until the operation. Both groups keep a food diary for 4 days right after the randomization and both one month and three months after the operation to assess the energy and nutrient intakes.

Laboratory markers, NRS 2002, quality of life questionnaire, exercise questionnaire, bioelectrical impedance analysis (BIA) and handgrip strength as well as body composition on computer tomography scan are assessed prior to any treatment or supplement in order to estimate the patients' well-being and nutritional status prior to surgical operation. Laboratory parameters and QoL questionnaire are repeated right before the operation on admission to hospital as well as about 30 and 90 days after the operation in addition to BIA, handgrip strength to assess the effect of nutritional support. Data on complications, infections, length of stay in the hospital and mortality are collected.

Another arm in this research is to discover more information on biological markers in colon cancer and cancer related malnutrition thus providing targets for future treatment and prognostic predictors. Tissue samples are collected during this research at the surgery.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gastrointestinal Cancer Patient Nutritional Management: From Specific Needs to Novel Epigenetic Dietary Approaches.
   Cencioni C, Trestini I, Piro G, Bria E, et al · · 2022 · cited 24× · PMID 35458104 · DOI 10.3390/nu14081542
2. Perioperative oral nutritional support for patients diagnosed with primary colon adenocarcinoma undergoing radical surgical procedures -Peri-Nutri Trial: study protocol for a randomized controlled trial.
   Aro R, Ohtonen P, Rautio T, Saarnio J, et al · · 2022 · cited 5× · PMID 36050804 · DOI 10.1186/s40795-022-00591-y
3. Perioperative Oral Nutritional Support For Patients Diagnosed With Primary Colon Adenocarcinoma Undergoing Radical Surgical Procedures -Peri-Nutri Trial: Study Protocol For A Randomized Controlled Trial.
   Aro R, Ohtonen P, Rautio T, Saarnio J, et al · · 2022 · DOI 10.21203/rs.3.rs-1425104/v1