Multimodal Program for Cancer Related Cachexia Prevention

NCT04627376 | Recruiting DMC

• 1 other identifier: CC-SPCC-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Cancer; Cachexia; Malnutrition; Educational Problems

Keywords

cachexia; prevention; management; malnutrition

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and week 4, week 8, week 12

Secondary Outcomes (4)

• Change from baseline in inflammation based on the CRP test at 12 weeks

  Baseline and week 4, week 8, week 12

• Change from baseline in edema according to albumin levels from baseline at 12 weeks

  Baseline and week 4, week 8, week 12

• Change from baseline of patient's Quality of life on the FAACT questionnaire (score) at 12 weeks

  Baseline and week 12

• Change from baseline (week 4) of family caregiver's Quality of life on the CarGOQoL questionnaire (score) at 12 weeks

  Week 4 and week 12

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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.

Other: Multimodal education and support program for cancer related cachexia prevention

Interventions

Multimodal education and support program for cancer related cachexia prevention OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cyprus University of Technology: lead
• German Oncology Center, Cyprus: collaborator

Study Sites (1)

German Oncology Centre

Limassol, 4065, Cyprus

RECRUITING

MeSH Terms

Conditions

Neoplasms; Cachexia; Malnutrition

Interventions

MME

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Andreas Charalambous, PhD

  Cyprus University of Technology Department of Nursing

  STUDY DIRECTOR

Central Study Contacts

Andreas Charalambous, PhD

CONTACT

00357-25002011; andreas.charalambous@cut.ac.cy

Constantina Cloconi, MSc

CONTACT

00357-96718110; tina_cl92@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Oncology and Palliative Care

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 13, 2020
• Study Start: September 24, 2020
• Primary Completion: February 1, 2023
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)