NCT02848807

Brief Summary

Determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 16, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

2.3 years

First QC Date

July 16, 2014

Last Update Submit

July 25, 2016

Conditions

Toxicity Due to ChemotherapyCancer CachexiaMetastatic Colorectal CancerQuality of LifeDietary Modification

Outcome Measures

Primary Outcomes (1)

  • Chemotherapy-related toxicity during 12th week of observation

    graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 4.0); to determine whether nutritional support with high protein ONS in adult oncologic patients in the first step of cancer cachexia - asymptomatic precachexia, influence on the toxicity of systemic therapy during 3 months observation period (comparison of the results at the baseline and after 12 weeks)

    at baseline and after 12th week

Secondary Outcomes (3)

  • Changes in the Nutritional status / metabolic status

    at baseline and after 12th week

  • Changes in the Quality of life and patients well-being

    at baseline and after 12th week

  • Changes in the Performance status

    at baseline and after 12th week

Study Arms (2)

NUTRIDRINK Compact Protein

ACTIVE COMPARATOR

NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice

Dietary Supplement: NUTRIDRINK Compact Protein

without oral nutritional supplements

NO INTERVENTION

Dietary advice alone

Interventions

NUTRIDRINK Compact ProteinDIETARY_SUPPLEMENT

high-energy, high-protein, oral liquid nutritional supplement; dosage: 2x125 ml per day, 7 days per week for 12 weeks (3 months)

Also known as: Oral nutritional supplement
NUTRIDRINK Compact Protein

Eligibility Criteria

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

You may qualify if:

  • histological confirmed diagnosis of CRC in clinical stage IV
  • successful qualification to chemotherapy
  • performance status at least 80% according to Karnofsky scale and \<2 according to WHO/ECOG scale
  • cancer-related asymptomatic precachexia diagnosed
  • absence of contraindications to oral nutrition and practicable realization of oral nutrition
  • absence of severe, decompensated concomitant diseases
  • signed informed consent for the participation in the study

You may not qualify if:

  • diagnosis of a malignant neoplasm in clinical stage I-III
  • disqualification from oncologic treatment
  • cancer cachexia or cancer anorexia-cachexia syndrome
  • poor performance status
  • contraindications to oral nutrition or to high protein nutrition
  • regular nutritional support at the moment of qualification to the study
  • patient incompliance at the moment of qualification to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Centre

Gdansk, Poland

RECRUITING

Related Publications (1)

  • Zietarska M, Malgorzewicz S. Quality of Life of Colorectal Cancer Patients Treated with Chemotherapy. Nutrients. 2026 Jan 7;18(2):191. doi: 10.3390/nu18020191.

    PMID: 41599804DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Sylwia Malgorzewicz, MD, PhD

    University Clinical Centre, Gdansk, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylwia Malgorzewicz, MD, PhD

CONTACT

+48 58 3492724sylwiam@gumed.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 29, 2016

Study Start

September 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 29, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

publication in nutritional and oncological journals, presentation on the congresses

Locations

PL(1)