NCT03863236

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

7 years

First QC Date

February 25, 2019

Last Update Submit

May 17, 2022

Conditions

Colon CancerSarcopenia

Keywords

colon cancer, nutritional support, complications, mortality,

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Primary end point is to investigate whether the pre and postoperative oral nutritional support decreases the number of complications during the 30-day follow up after the surgery

    complications are studied in every patients 30 days after operation

Secondary Outcomes (4)

  • Nutrition and Quality of life

    5-year

  • Disease free and overall survival

    5-year

  • 90-day mortality

    90 days

  • Hospital stay

    90 days

Study Arms (2)

regular diet

ACTIVE COMPARATOR

The control group (group 1) will continue their regular diet.

Dietary Supplement: regular diet

nutritional support Resource 2.5

ACTIVE COMPARATOR

The intervention group (group 2) will get preoperative nutritional support two weeks before the operation and the nutritional support will continue 10 days after the operation.

Dietary Supplement: nutritional support Resource 2.5

Interventions

regular dietDIETARY_SUPPLEMENT

The control group (group 1) will continue their regular diet.

regular diet
nutritional support Resource 2.5DIETARY_SUPPLEMENT

The intervention group (group 2) will get preoperative nutritional support (Resource 2.5 Compact/fibre combact) two weeks before the operation and the nutritional support will continue 10 days after the operation.

nutritional support Resource 2.5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Primary colon adenocarcinoma
  • Curative operation is possible
  • Patient has a life expectancy of at least 12 months
  • Patient signs the informed consent and agrees to attend all study visits

You may not qualify if:

  • Recurrent colon adenocarcinoma
  • Metastatic disease
  • Cancer that will require multiorgan resection
  • Pregnant or suspected pregnancy
  • Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 5).
  • Patients with concurrent or previous malignant tumors within 5 years before the study enrollment
  • Patient undergoing emergency procedures
  • Dialysis
  • Liver dysfunction, child pugh B or worse
  • NRS score \<2 or \>5
  • BMI under 18.5
  • Weight loss 15% or more past 6 months
  • Serum albumin less than 30 without liver or renal dysfunction
  • Chronic malnutrition: short bowel syndrome, previous gastrectomy, pancreatic dysfunction
  • Language barrier or other reasons why informed consent is not possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, Finland

RECRUITING

Related Publications (1)

  • Aro R, Ohtonen P, Rautio T, Saarnio J, Makarainen E, Haivala R, Makinen MJ, Tuomisto A, Schwab U, Merilainen S. 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. BMC Nutr. 2022 Sep 2;8(1):89. doi: 10.1186/s40795-022-00591-y.

    PMID: 36050804DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsSarcopenia

Interventions

Diet

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Juha Saarnio, docent

    Oulun yliopisto

    STUDY DIRECTOR

Central Study Contacts

Raila Aro

CONTACT

+358505794375railaaro@student.oulu.fi

Sanna Meriläinen

CONTACT

+358505794143Sanna.Merilainen@ppshp.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 5, 2019

Study Start

April 1, 2019

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)