Chemotherapy-related Toxicity, Nutritional Status and Quality of Life

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)

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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