Cachexia; CancerNCT04161794
Multimodal Intervention for Patients With Non-small Cell Lung Cancer
A study testing multimodal in people with Cachexia; Cancer, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
A single-arm intervention study assessing the feasibility of a multimodal intervention of management of cancer cachexia in patients with non-small cell lung cancer during primary anti-neoplastic treatment. The effects of the intervention is compared to a historical control group Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia; Cancer
- What is being tested?
- multimodal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2018to 30 Apr 2019
- 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
- histopathologically or cytologically verified with NSCLC
- inoperable tumour, candidates for, but naïve to or no systemic anti-neoplastic treatment the previous two years
- commence first line of chemotherapy (carboplatin/vinorelbin, cisplatin/vinorelbin) with or without radiation therapy or pembrolizumab
- performance status ≤2 (Eastern Cooperative Oncology Group)
- age >18 and provided oral
- written consent
Who cannot join
- excessive alcohol or drug abuse
- incapable to follow the intervention (i.e. cognitive problems or unable to walk) were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Intervention (Dietary Counselling, Fish Oil and Physical Training) for Patients With Non-small Cell Lung Cancer, a Feasibility Study
A single-arm intervention study assessing the feasibility of a multimodal intervention of management of cancer cachexia in patients with non-small cell lung cancer during primary anti-neoplastic treatment. The effects of the intervention is compared to a historical control group
Read the detailed description
In a single arm intervention study, we will provide a multimodal intervention consisting of dietary counselling, physical exercises plan as well as fish oil.
The target of the dietary counselling is:
- 30 kcal/kg/d (in patients with BMI <30) or 25 kcal/kg/d (in patients with BMI => 30)
- at least 1.0 g protein/kg/d
- three daily meals of at least 20 g of protein
- restrict overnight fasting to a maximum of 11 hours
The initial dietary counselling is at the first cycle of anti-neoplastic treatment. The patient will be provided an individual plan to meet the dietary targets tailored to the individual preferences and symptoms. At every cycle of anti-neoplastic treatment, the plan will be adjusted if needed. At every week the patients will be prompted by telephone to comply with the dietary plan.
The physical exercise consists of two exercises:
- strength training: a progressive sit-to-stand exercise which is a lower extremity exercise.
- cardio-vascular training: a progressive brisk walking plan. Patients are prompted to execute both exercises twice weekly. The individual targets are set at the first cycle of anti-neoplastic treatment and adjusted during the trial.
Fish oil:
The patients are instructed to ingest 10g of liquid fish oil (consisting of 2 g EPA/DHA) or 8 capsules of fish oil (consisting of 2 g EPA/DHA)
- Conditions
- Cachexia; Cancer
- Being tested
- multimodal
- Keywords
- cachexia, cancer, multimodal intervention
- Medical subject headings
- Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodalOther
2 g EPA/DHA as fish oil, repeated dietary counselling and twice weekly 2 x exercises
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 2 g EPA/DHA via fish oil daily Regular dietary counselling Twice weekly strength and cardiovascular exercise Receives: Other: multimodal |
| Historical control group | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, recruitment rate
Recruitment rate is measured by dividing the number of patients consented by the number of patients screened
Measured: 9 months
Feasibility, retention rate
Retention rate is measured by dividing the number of patients completing the trial with the number of patients consented
Measured: 9 months
Feasibility, compliance
The overall compliance was defined successful if at least half of the included patients reached at least 75 % of the nutrient target, consumed at least 75 % of the fish oil and conducted at least 50 % of the physical exercises
Measured: 9-18 weeks
Secondary outcomes (5)
Predictive and prognostic factors of change in skeletal muscle
Change in skeletal muscle was measured using CT scans, analysed at the 3rd lumbar vertebra, expressed as actual change in square centimeter. Using an ordinal logistic regression model, patients were ordered in three Groups (muscle wasting: loss of at least 6 cm^2 ; muscle maintenance: +/- 5.9 cm^2; muscle gain: gain of at least 6.0 cm^2). The baseline variables included in the model are age, gender, tumor stage, type of treatment, performance status, inflammatory score (mGPS) and cachexia. The possible prognostic factors included in the model is change in body weight, adherence to the anti-neoplastic treatment plan, treatment response, compliance to the multimodal intervention, number of Nutrition impact symptoms, days in between CT scans, energy and protein intake.
Measured: 9-18 weeks
Group difference in body weight
The change in body weight (measured at baseline and at the end of the trial using body weight scales, expressed as %
Measured: 9-18 weeks
Group difference in skeletal muscle
Change in skeletal muscle (measured using CT scans, expressed as actual muscle change at the 3rd lumbar vertebra in mean (SD) cm^2
Measured: 9-18 weeks
Proportion of patients gaining, maintaining and wasting of skeletal muscle
expressed as number of patients. Gaining defined as at least +6 Square centimeter skeletal muscle. Maintaining defined as: +/- 5.9 Square centimeter skeletal muscle. Wasting defined as: at least -6 Square centimeter skeletal muscle
Measured: 9-18 weeks
Change in physical function
assessed by timed-up-and-go test (expressed in number of seconds) and assessed by 30 seconds sit-to-stand test (expressed as number of stands).
Measured: 9-18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start15 Feb 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cachexia; CancerStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a single arm intervention study, comparing the results to that of a historical control Group.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randi Tobberup, Aalborg University Hospital
- Investigators
- Mette Holst, PhD, Study chair, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161794
- Sponsor's protocol ID
- LUCANU-2
- Status last verified
- Nov 2019
- First submitted
- 24 Sep 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tobberup R, Carus A, Rasmussen HH, Falkmer UG, Jorgensen MG, Schmidt EB, Jensen NA, Mark EB, Delekta AM, Antoniussen CS, Bogsted M, Holst M. Feasibility of a multimodal intervention on malnutrition in patients with lung cancer during primary anti-neoplastic treatment. Clin Nutr. 2021 Feb;40(2):525-533. doi: 10.1016/j.clnu.2020.05.050. Epub 2020 Jun 9.
PubMed 32600857
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Intervention (Dietary Counselling, Fish Oil and Physical Training) for Patients With Non-small Cell Lung Cancer, a Feasibility Study
- ClinicalTrials.gov ID
- NCT04161794
- Acronym / sponsor ID
- LUCANU-2
- Conditions
- Cachexia; Cancer
- Keywords
- cachexia, cancer, multimodal intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 13 Nov 2019 (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.
A single-arm intervention study assessing the feasibility of a multimodal intervention of management of cancer cachexia in patients with non-small cell lung cancer during primary anti-neoplastic treatment. The effects of the intervention is compared to a historical control group
Detailed description
In a single arm intervention study, we will provide a multimodal intervention consisting of dietary counselling, physical exercises plan as well as fish oil.
The target of the dietary counselling is:
- 30 kcal/kg/d (in patients with BMI <30) or 25 kcal/kg/d (in patients with BMI => 30)
- at least 1.0 g protein/kg/d
- three daily meals of at least 20 g of protein
- restrict overnight fasting to a maximum of 11 hours
The initial dietary counselling is at the first cycle of anti-neoplastic treatment. The patient will be provided an individual plan to meet the dietary targets tailored to the individual preferences and symptoms. At every cycle of anti-neoplastic treatment, the plan will be adjusted if needed. At every week the patients will be prompted by telephone to comply with the dietary plan.
The physical exercise consists of two exercises:
- strength training: a progressive sit-to-stand exercise which is a lower extremity exercise.
- cardio-vascular training: a progressive brisk walking plan. Patients are prompted to execute both exercises twice weekly. The individual targets are set at the first cycle of anti-neoplastic treatment and adjusted during the trial.
Fish oil:
The patients are instructed to ingest 10g of liquid fish oil (consisting of 2 g EPA/DHA) or 8 capsules of fish oil (consisting of 2 g EPA/DHA)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single arm intervention study, comparing the results to that of a historical control Group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: multimodal2 g EPA/DHA via fish oil daily Regular dietary counselling Twice weekly strength and cardiovascular exercise |
| Historical control group | No intervention | –Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histopathologically or cytologically verified with NSCLC
- inoperable tumour, candidates for, but naïve to or no systemic anti-neoplastic treatment the previous two years
- commence first line of chemotherapy (carboplatin/vinorelbin, cisplatin/vinorelbin) with or without radiation therapy or pembrolizumab
- performance status ≤2 (Eastern Cooperative Oncology Group)
- age >18 and provided oral
Key exclusion criteria (2 listed)
- excessive alcohol or drug abuse
- incapable to follow the intervention (i.e. cognitive problems or unable to walk) were excluded.
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 |
|---|---|---|
| multimodal2 g EPA/DHA as fish oil, repeated dietary counselling and twice weekly 2 x exercises | Other | Intervention group |
Primary outcome
Feasibility, recruitment rate
Time frame: 9 months
Recruitment rate is measured by dividing the number of patients consented by the number of patients screened
Feasibility, retention rate
Time frame: 9 months
Retention rate is measured by dividing the number of patients completing the trial with the number of patients consented
Feasibility, compliance
Time frame: 9-18 weeks
The overall compliance was defined successful if at least half of the included patients reached at least 75 % of the nutrient target, consumed at least 75 % of the fish oil and conducted at least 50 % of the physical exercises
5 secondary outcomes
Predictive and prognostic factors of change in skeletal muscle
Time frame: 9-18 weeks
Group difference in body weight
Time frame: 9-18 weeks
Group difference in skeletal muscle
Time frame: 9-18 weeks
Proportion of patients gaining, maintaining and wasting of skeletal muscle
Time frame: 9-18 weeks
Change in physical function
Time frame: 9-18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Derived from this study: PubMed 32600857Tobberup R, Carus A, Rasmussen HH, Falkmer UG, Jorgensen MG, Schmidt EB, Jensen NA, Mark EB, Delekta AM, Antoniussen CS, Bogsted M, Holst M. Feasibility of a multimodal intervention on malnutrition in patients with lung cancer during primary anti-neoplastic treatment. Clin Nutr. 2021 Feb;40(2):525-533. doi: 10.1016/j.clnu.2020.05.050. Epub 2020 Jun 9.
- 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.
Mette Holst, PhD study chair
Aalborg University Hospital
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 in people with Cachexia; Cancer, run by Aalborg University Hospital at 1 site in Denmark.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 13 Nov 2019. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, recruitment rate (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161794, which also lists 1 linked publication.
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 13 Nov 2019.