Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-30 @ 10:47 AM
Study NCT ID:
NCT04161794
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2019-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Intervention for Patients With Non-small Cell Lung Cancer
Sponsor:
Aalborg University Hospital
Organization:
Study Overview
Official Title:
Multimodal Intervention (Dietary Counselling, Fish Oil and Physical Training) for Patients With Non-small Cell Lung Cancer, a Feasibility Study
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: