Clinical trial NCT04161794: Multimodal Intervention for Patients With Non-small Cell Lung Cancer
Official title: Multimodal Intervention (Dietary Counselling, Fish Oil and Physical Training) for Patients With Non-small Cell Lung Cancer, a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cachexia; Cancer
Keywords: cachexia
cancer
multimodal intervention
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm intervention study, comparing the results to that of a historical control Group.
Primary purpose: SUPPORTIVE_CARE

Brief 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

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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* excessive alcohol or drug abuse
* incapable to follow the intervention (i.e. cognitive problems or unable to walk) were excluded.

Primary outcomes:
measure: Feasibility, recruitment rate
timeFrame: 9 months
measure: Feasibility, retention rate
timeFrame: 9 months
measure: Feasibility, compliance
timeFrame: 9-18 weeks
Secondary outcomes:
measure: Predictive and prognostic factors of change in skeletal muscle
timeFrame: 9-18 weeks
measure: Group difference in body weight
timeFrame: 9-18 weeks
measure: Group difference in skeletal muscle
timeFrame: 9-18 weeks
measure: Proportion of patients gaining, maintaining and wasting of skeletal muscle
timeFrame: 9-18 weeks
measure: Change in physical function
timeFrame: 9-18 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Univeristy Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Mette Holst, PhD
role: STUDY_CHAIR
References:
citation: 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.