NCT04476082

Brief Summary

Malnutrition and loss of muscle mass frequently occur in patients undergoing chemotherapy and can negatively effect therapy outcome. Especially patients with cancer of the gastrointestinal tract are often affected by malnutrition. Therefore, this study aims to examine changes in nutritional status of patients with cancer of the gastrointestinal tract during chemotherapy. Findings of this study will help to improve nutritional treatment of patients undergoing chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 25, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

2.4 years

First QC Date

June 29, 2020

Last Update Submit

January 22, 2023

Conditions

Pancreatic CancerOesophageal CancerColon CancerLiver CancerRectal CancerBile Duct CancerGIST, MalignantNeuroendocrine TumorsSmall Intestine CancerGastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Malnutrition According to the Global Leadership Initiative on Malnutrition criteria (GLIM criteria)

    Change in prevalence of malnutrition according to the GLIM criteria

    3 months after study enrollment

Secondary Outcomes (36)

  • Prevalence of Malnutrition According to the European Society for Clinical Nutrition and Metabolism criteria (ESPEN criteria)

    3 months after study enrollment

  • Skeletal Muscle Mass

    3 months after study enrollment

  • Fat Free Mass

    3 months after study enrollment

  • Fat Mass

    3 months after study enrollment

  • Total Body Water

    3 months after study enrollment

  • +31 more secondary outcomes

Study Arms (2)

Initial Diagnosis

Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment.

Other: No intervention - observational study only

Ongoing Cytostatic Treatment

Patients with a malignant condition of the gastrointestinal tract already receiving cytostatic treatment.

Other: No intervention - observational study only

Interventions

No intervention - observational study onlyOTHER

No intervention - observational study only

Initial DiagnosisOngoing Cytostatic Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited at University Medicine Greifswald (Northeast Germany). Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment will be identified in the gastrointestinal ward of the hosptial. Recruitment of patients receiving cytostatic treatment of a known malignant condition of the gastrointestinal tract will take place in the hospital's cancer day unit.

You may qualify if:

  • Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment.
  • ongoing cytostatic treatment of a known malignant condition of the gastrointestinal tract

You may not qualify if:

  • pregnancy
  • history of any other malignant tumor disease
  • inability to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine Greifswald

Greifswald, 17475, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Plasma, Faeces

MeSH Terms

Conditions

Pancreatic NeoplasmsEsophageal NeoplasmsColonic NeoplasmsLiver NeoplasmsRectal NeoplasmsBile Duct NeoplasmsGastrointestinal Stromal TumorsNeuroendocrine TumorsStomach Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsEsophageal DiseasesGastrointestinal DiseasesColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesLiver DiseasesRectal DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueStomach Diseases

Study Officials

  • Ali A Aghdassi, Professor

    University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 17, 2020

Study Start

June 25, 2020

Primary Completion

December 6, 2022

Study Completion

December 6, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

DE(1)