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Chemotherapy-related Toxicity, Nutritional Status and Quality of Life

U

University Clinical Centre, Gdansk

Status

Unknown

Conditions

Quality of Life
Metastatic Colorectal Cancer
Dietary Modification
Cancer Cachexia
Toxicity Due to Chemotherapy

Treatments

Dietary Supplement: NUTRIDRINK Compact Protein

Study type

Interventional

Funder types

Other

Identifiers

NCT02848807
01/2014/UCK

Details and patient eligibility

About

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.

Full description

Other endpoints:

  • to determine whether high protein ONS influence on the nutritional status
  • to determine whether high protein ONS influence on the quality of life
  • to determine whether high protein ONS influence on the performance status
  • to determine high protein ONS tolerability / ONS intake compliance

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

NUTRIDRINK Compact Protein
Active Comparator group
Description:
NUTRIDRINK Compact Protein Oral nutritional supplement Dietary advice
Treatment:
Dietary Supplement: NUTRIDRINK Compact Protein
without oral nutritional supplements
No Intervention group
Description:
Dietary advice alone

Trial contacts and locations

1

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Central trial contact

Sylwia Malgorzewicz, MD, PhD

Data sourced from clinicaltrials.gov

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