NeoplasmsNCT04627376
Multimodal Program for Cancer Related Cachexia Prevention
A study testing Multimodal education and support program for cancer related cachexia prevention in people with Neoplasms and Cancer, run by Cyprus University of Technology at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Multimodal education and support program for cancer related cachexia prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCyprus
- Study dates
- 24 Sep 2020to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
German Oncology Centre
Limassol, 4065
Constantina Cloconi, MSc, 00357-96718110, tina_cl92@hotmail.com
About this study
Official title: Effectiveness of a Multimodal Education and Support Program for the Prevention of Cancer Related Cachexia for Patients and Their Family Caregiver
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.
Read the 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.
- Conditions
- Neoplasms, Cancer, Cachexia, Malnutrition, Educational Problems
- Being tested
- Multimodal education and support program for cancer related cachexia prevention
- Keywords
- cachexia, prevention, management, malnutrition
- Medical subject headings
- Neoplasms, Cachexia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal education and support program for cancer related cachexia preventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multimodal education and support program for cancer related cachexia prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 4, week 8, week 12
Secondary outcomes (4)
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.
Measured: Baseline and week 4, week 8, week 12
Change from baseline in edema according to albumin levels from baseline at 12 weeks
Blood test for Albumin Levels. normal ranges >35g/L
Measured: 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
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
Measured: Baseline and week 12
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
Measured: Week 4 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start24 Sep 2020
- Primary completionFeb 2023 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- German Oncology Center, Cyprus
- Responsible party
- Principal investigator, Dr. Andreas Charalambous, Cyprus University of Technology
- Investigators
- Andreas Charalambous, PhD, Study director, Cyprus University of Technology Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627376
- Sponsor's protocol ID
- CC-SPCC-1
- Status last verified
- Sep 2022
- First submitted
- 27 Oct 2020
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multimodal Education and Support Program for the Prevention of Cancer Related Cachexia for Patients and Their Family Caregiver
- ClinicalTrials.gov ID
- NCT04627376
- Acronym / sponsor ID
- CC-SPCC-1
- Conditions
- Neoplasms, Cancer, Cachexia, Malnutrition, Educational Problems
- Keywords
- cachexia, prevention, management, malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Collaborators
- German Oncology Center, Cyprus
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Multimodal education and support program for cancer related cachexia prevention12-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal education and support program for cancer related cachexia prevention12-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 | Intervention |
Primary outcome
Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks
Time frame: Baseline and week 4, week 8, week 12
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.
4 secondary outcomes
Change from baseline in inflammation based on the CRP test at 12 weeks
Time frame: Baseline and week 4, week 8, week 12
Change from baseline in edema according to albumin levels from baseline at 12 weeks
Time frame: 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
Time frame: Baseline and week 12
Change from baseline (week 4) of family caregiver's Quality of life on the CarGOQoL questionnaire (score) at 12 weeks
Time frame: Week 4 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Charalambous, PhD study director
Cyprus University of Technology Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal education and support program for cancer related cachexia prevention in people with Neoplasms and Cancer, run by Cyprus University of Technology at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Charalambous, PhD (00357-25002011, andreas.charalambous@cut.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks (time frame: Baseline and week 4, week 8, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.