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Multimodal Program for Cancer Related Cachexia Prevention

Primary Purpose

Neoplasms, Cancer, Cachexia

Status
Recruiting
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Multimodal education and support program for cancer related cachexia prevention
Sponsored by
Cyprus University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neoplasms focused on measuring cachexia, prevention, management, malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years old or older
  2. Participants must be diagnosed with solid tumour (stomach, colorectal, pancreas, breast, lung)
  3. Participants needing chemotherapy/immunotherapy/hormone therapy/target therapy
  4. Participants must be normal or pre cachectic as defined by the guidelines
  5. Read and understand Greek or English

Exclusion Criteria:

  1. Haematologic tumors
  2. Parenteral Nutrition
  3. ECOG Performance status >2 or Karnofsky Performance Status <60%
  4. Participant who can not introduce a family caregiver

  5. Participants in cachexia or refractory cachexia stage as defined by the guidelines below:

    • >5% weight loss over the past 6 months (in absence of simple starvation); OR
    • BMI <20 and any degree of weight loss >2%; OR
    • Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men <14.6 kg/m²; women <11.4 kg/m²) and weight loss >2%
  6. Patients who use complementary therapies (ex-acupuncture)

Sites / Locations

  • German Oncology CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

12-weeks multimodal program includes: 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires.

12-weeks multimodal program includes: 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires, education on their diet and symptom management related to anti cancer treatment.

Outcomes

Primary Outcome Measures

Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks
To assess the patient's baseline cancer cachexia stage with weight (weight loss <5% in previous three months, kg), height (cm) and BMI (BMI > 20) measurements.

Secondary Outcome Measures

Change from baseline in inflammation based on the CRP test at 12 weeks
Blood test for C-reactive protein (mg/L). CRP level greater than 10 mg/L is a sign of active inflammation.
Change from baseline in edema according to albumin levels from baseline at 12 weeks
Blood test for Albumin Levels. normal ranges >35g/L
Change from baseline of patient's Quality of life on the FAACT questionnaire (score) at 12 weeks
Participants will fill the questionnaire at baseline and at week 12 to compare the score of FAACT. The FAACT questionnaire is validated, self-reported instrument (28-item) assessing the quality of life of cancer patients with any tumour type. Possible scores range from 0 (lower quality of life) to 112 (better quality of life). Change = Week 12 - Baseline
Change from baseline (week 4) of family caregiver's Quality of life on the CarGOQoL questionnaire (score) at 12 weeks
Participants will fill the questionnaire at week 4 and at week 12 to compare the score of CarGOQoL. The CarGOQoL questionnaire is validated, self-reported instrument (29 items investigating 10 domains) assessing the quality of life of family caregivers. Possible scores range from 0 (lower quality of life) to 100 (better quality of life). Change = Week 12 - Week 4

Full Information

First Posted
October 27, 2020
Last Updated
September 1, 2022
Sponsor
Cyprus University of Technology
Collaborators
German Oncology Center, Cyprus
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1. Study Identification

Unique Protocol Identification Number
NCT04627376
Brief Title
Multimodal Program for Cancer Related Cachexia Prevention
Official Title
Effectiveness of a Multimodal Education and Support Program for the Prevention of Cancer Related Cachexia for Patients and Their Family Caregiver
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cyprus University of Technology
Collaborators
German Oncology Center, Cyprus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to evaluate the effectiveness of a multifactorial education and support program for the prevention of cancer-related cachexia syndrome, for patients and their family caregivers during anti-cancer treatment.
Detailed Description
After being informed about the study and the need to nominate a family caregiver, all patients and their family caregiver giving written informed consent, they will undergo a 12-weeks multimodal program. Randomly they will divided into two groups (intervention and control). This 12-weeks multimodal program includes 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires, education on their diet and symptom management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Cancer, Cachexia, Malnutrition, Educational Problems
Keywords
cachexia, prevention, management, malnutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
12-weeks multimodal program includes: 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
12-weeks multimodal program includes: 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires, education on their diet and symptom management related to anti cancer treatment.
Intervention Type
Other
Intervention Name(s)
Multimodal education and support program for cancer related cachexia prevention
Intervention Description
12-weeks multimodal program includes: 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires, education on their diet and symptom management related to anti cancer treatment.
Primary Outcome Measure Information:
Title
Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks
Description
To assess the patient's baseline cancer cachexia stage with weight (weight loss <5% in previous three months, kg), height (cm) and BMI (BMI > 20) measurements.
Time Frame
Baseline and week 4, week 8, week 12
Secondary Outcome Measure Information:
Title
Change from baseline in inflammation based on the CRP test at 12 weeks
Description
Blood test for C-reactive protein (mg/L). CRP level greater than 10 mg/L is a sign of active inflammation.
Time Frame
Baseline and week 4, week 8, week 12
Title
Change from baseline in edema according to albumin levels from baseline at 12 weeks
Description
Blood test for Albumin Levels. normal ranges >35g/L
Time Frame
Baseline and week 4, week 8, week 12
Title
Change from baseline of patient's Quality of life on the FAACT questionnaire (score) at 12 weeks
Description
Participants will fill the questionnaire at baseline and at week 12 to compare the score of FAACT. The FAACT questionnaire is validated, self-reported instrument (28-item) assessing the quality of life of cancer patients with any tumour type. Possible scores range from 0 (lower quality of life) to 112 (better quality of life). Change = Week 12 - Baseline
Time Frame
Baseline and week 12
Title
Change from baseline (week 4) of family caregiver's Quality of life on the CarGOQoL questionnaire (score) at 12 weeks
Description
Participants will fill the questionnaire at week 4 and at week 12 to compare the score of CarGOQoL. The CarGOQoL questionnaire is validated, self-reported instrument (29 items investigating 10 domains) assessing the quality of life of family caregivers. Possible scores range from 0 (lower quality of life) to 100 (better quality of life). Change = Week 12 - Week 4
Time Frame
Week 4 and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old or older Participants must be diagnosed with solid tumour (stomach, colorectal, pancreas, breast, lung) Participants needing chemotherapy/immunotherapy/hormone therapy/target therapy Participants must be normal or pre cachectic as defined by the guidelines Read and understand Greek or English Exclusion Criteria: Haematologic tumors Parenteral Nutrition ECOG Performance status >2 or Karnofsky Performance Status <60% Participant who can not introduce a family caregiver Participants in cachexia or refractory cachexia stage as defined by the guidelines below: >5% weight loss over the past 6 months (in absence of simple starvation); OR BMI <20 and any degree of weight loss >2%; OR Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men <14.6 kg/m²; women <11.4 kg/m²) and weight loss >2% Patients who use complementary therapies (ex-acupuncture)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Charalambous, PhD
Phone
00357-25002011
Email
andreas.charalambous@cut.ac.cy
First Name & Middle Initial & Last Name or Official Title & Degree
Constantina Cloconi, MSc
Phone
00357-96718110
Email
tina_cl92@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Charalambous, PhD
Organizational Affiliation
Cyprus University of Technology Department of Nursing
Official's Role
Study Director
Facility Information:
Facility Name
German Oncology Centre
City
Limassol
ZIP/Postal Code
4065
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constantina Cloconi, MSc
Phone
00357-96718110
Email
tina_cl92@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Multimodal Program for Cancer Related Cachexia Prevention

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