Multimodal Program for Cancer Related Cachexia Prevention

Cyprus University of Technology

Status: Enrolling

Conditions: Malnutrition; Neoplasms; Cachexia; Cancer; Educational Problems

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04627376

CC-SPCC-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Control

No Intervention group

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.

Intervention

Experimental group

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.

Treatment:

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