Multimodal Program for Cancer Related Cachexia Prevention

NCT ID: NCT04627376

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-24

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Neoplasms Cancer Cachexia Malnutrition Educational Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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, education on their diet and symptom management related to anti cancer treatment.

Group Type EXPERIMENTAL

Multimodal education and support program for cancer related cachexia prevention

Intervention Type 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.

Interventions

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Multimodal education and support program for cancer related cachexia prevention

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

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Oncology Center, Cyprus

OTHER

Sponsor Role collaborator

Cyprus University of Technology

OTHER

Sponsor Role lead

Responsible Party

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Dr. Andreas Charalambous

Associate Professor Oncology and Palliative Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Charalambous, PhD

Role: STUDY_DIRECTOR

Cyprus University of Technology Department of Nursing

Locations

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German Oncology Centre

Limassol, , Cyprus

Site Status RECRUITING

Countries

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Cyprus

Central Contacts

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Andreas Charalambous, PhD

Role: CONTACT

00357-25002011

Constantina Cloconi, MSc

Role: CONTACT

00357-96718110

Facility Contacts

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Constantina Cloconi, MSc

Role: primary

00357-96718110

Other Identifiers

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CC-SPCC-1

Identifier Type: -

Identifier Source: org_study_id

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