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

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ClinicalTrials.gov Identifier: NCT03863236
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oulu

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colon Cancer Sarcopenia Dietary Supplement: regular diet Dietary Supplement: nutritional support Resource 2.5 Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Randomized Study of Perioperative Oral Nutritional Support for Patients Having Surgery for Colon Cancer. Peri-Nutri
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2026
Estimated Study Completion Date : April 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: regular diet
The control group (group 1) will continue their regular diet.
 Dietary Supplement: regular diet
The control group (group 1) will continue their regular diet.
Active Comparator: nutritional support Resource 2.5
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative complications [ Time Frame: complications are studied in every patients 30 days after operation ]
    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


Secondary Outcome Measures :
  1. Nutrition and Quality of life [ Time Frame: 5-year ]
    study the effect of oral nutritional support on quality of life after surgery (RAND-65 questionnaire)

  2. Disease free and overall survival [ Time Frame: 5-year ]
    study the effect of oral nutritional support on patients disease free and overall survival

  3. 90-day mortality [ Time Frame: 90 days ]
    effect of nutritional support on 90-day mortality

  4. Hospital stay [ Time Frame: 90 days ]
    The aim is also to investigate whether the oral nutritional support can shorten the hospital stay


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863236


Contacts
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Contact: Raila Aro +358505794375 railaaro@student.oulu.fi
Contact: Sanna Meriläinen +358505794143 Sanna.Merilainen@ppshp.fi

Locations
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Finland
Oulu University Hospital Recruiting
Oulu, Finland
Contact: Raila Aro         
Contact: Sanna Meriläinen         
Sponsors and Collaborators
University of Oulu
Investigators
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Study Director: Juha Saarnio, docent Oulun yliopisto
More Information
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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT03863236     History of Changes
Other Study ID Numbers: 235/2018
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oulu:
colon cancer, nutritional support, complications, mortality,
Additional relevant MeSH terms:
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Colonic Neoplasms
Sarcopenia
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms