NCT05648955

Brief Summary

Malnutrition and low muscle mass (sarcopenia) are common problems in patients with cancer. However, a low muscle mass is associated with negative clinical outcomes in patients with cancer. Therefore, it is very important to maintain muscle mass in this population. This study aims to investigate the effect of an oral nutritional supplement on skeletal muscle mass during anti-cancer treatment.

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
118

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Mar 2023

Typical duration for early_phase_1

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

August 10, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

August 10, 2022

Last Update Submit

July 25, 2023

Conditions

Colorectal Cancer (CRC)Non-small Cell Lung Cancer (NSCLC)

Keywords

Muscle massoral nutritional supplementcolorectal cancernon-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Change in cross-sectional skeletal muscle mass area on the third vertebral level (L3) [cm2]

    between baseline and after 12 weeks of intervention as measured with a CT scan, between the two interventions

    12 weeks

Secondary Outcomes (1)

  • Change in health-related quality of life as measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30 global health score)

    ~13 weeks

Other Outcomes (4)

  • Change in health-related quality of life as measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30 global health score)

    ~13 weeks

  • Inflammation status

    ~13 weeks

  • Change in performance status ECOG

    ~13 weeks

  • +1 more other outcomes

Study Arms (2)

Test product

EXPERIMENTAL

An enriched high protein and high energy oral nutrition supplement (ONS)

Dietary Supplement: an enriched high protein and high energy oral nutrition supplement (ONS)

Control product

ACTIVE COMPARATOR

standard isocaloric high energy normal protein isocaloric ONS

Dietary Supplement: an enriched high protein and high energy oral nutrition supplement (ONS)

Interventions

an enriched high protein and high energy oral nutrition supplement (ONS)DIETARY_SUPPLEMENT

NA (see intervention name)

Control productTest product

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of stage III or IV colorectal or non-small cell lung cancer
  • Scheduled for the first cycle of any line of a systemic treatment: chemotherapy, concurrent chemoradiotherapy, immunotherapy or targeted treatment with a planned duration of at least 9 weeks
  • Performance status Eastern Cooperative Oncology Group (ECOG) score 0 or 1
  • Age ≥ 18 years

You may not qualify if:

  • Weight loss \>10% in the last 6 months
  • Body Mass Index \> 30.0 kg/m2
  • Life expectancy \< 3 months
  • Receiving enteral (tube) or parenteral nutrition
  • Presence of ileostoma or ileal pouch (except for an ileostomy at or near the terminal ileum which does not affect absorption of nutrients other than sodium, potassium, and water, in the opinion of the investigator)
  • Allergy to cow's milk protein, soy or fish, requiring a fibre-free diet or suffering galactosemia or lactose intolerance
  • Known pregnancy or lactation
  • Current alcohol or drug abuse in the opinion of the investigator
  • Wearing an electronic implant and/or pacemaker
  • Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
  • Participation in any other studies involving investigational or marketed products concomitantly or within 14 days prior to entry into the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCC

Cork, Ireland

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Danone Nutricia Research

CONTACT

+31 30 2095 000register.clinicalresearchnutricia@danone.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2022

First Posted

December 13, 2022

Study Start

March 31, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)