Chemotherapy-related Toxicity, Nutritional Status and Quality of Life

Quality of Life Clinical Trial

Official title:

Chemotherapy-related Toxicity, Nutritional Status and Quality of Life in Precachectic Oncologic Patients With or Without High Protein Nutritional Support. A Prospective, Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02848807
• Other study ID #: 01/2014/UCK
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2014
• Last updated: July 25, 2016
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: University Clinical Centre, Gdansk
• Contact: Sylwia Malgorzewicz, MD, PhD
• Phone: +48 58 3492724
• Email: sylwiam[@]gumed.edu.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Poland	University Clinical Centre	Gdansk

Sponsors (2)

Lead Sponsor	Collaborator
University Clinical Centre, Gdansk	Nutricia Foundation

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in the Nutritional status / metabolic status	the assessment according to Nutritional Risk Screening 2002 (NRS 2002), Subjective Global Assessment (SGA), body mass, body mass index (BMI), VAS for appetite, albumin, prealbumin, triglycerides, total cholesterol, fasting blood glucose, C-reactive protein (CRP), ferritin, complete blood count.; Body mass (in kg) will measure by the scales (Tanita BC 420). Hight ( in cm) measure by Stadiometer (Tanita); Body mass index calculation (BMI) on the basis of the following formula: BMI = body weight / height2 (kg/m2).; VAS for appetite is 100-mm line where 0 mm means "I had no appetite at all" and 100 mm means "My appetite was very good".; Laboratory parameters will measured by routine laboratory methods. All results will be compared between study groups (ONS vs without ONS) at the same time point (eg. baseline group ONS vs baseline group without ONS)	at baseline and after 12th week	No
Secondary	Changes in the Quality of life and patients well-being	FAACT-ESPEN score Version 4 (Functional Assessment of Anorexia/Cachexia Therapy questionnaire) is a measure of the quality of life and it is completed by a patient, it has a total of 42 questions. Patients mark 0 (none) - 4 (very much) for each question. This tool consists of five subscales: functional well-being (7 items), physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and other aspects, including appetite (13 items).; The maximum score is 168. The lower the score, the lower overall quality of life.	at baseline and after 12th week	No
Secondary	Changes in the Performance status	To performance status assessment will be used Kornofsky scale and ECOG scale. The Karnofsky score allows to quantify the overall state and quality of life of a patient with neoplastic disease who qualifies to receive chemotherapy. The score has a range from 0 to 100, where 100 represents the ideal state and 0 - death.; The Eastern Cooperative Oncology Group(ECOG) score runs from 0 to 5, with 0 denoting perfect health and 5 death.	at baseline and after 12th week	No