Multimodal Intervention for Patients With Non-small Cell Lung Cancer

Aalborg University Hospital

Status: Completed

Conditions: Cachexia; Cancer

Treatments: Other: multimodal

Study type: Interventional

Funder types: Other

Identifiers

NCT04161794

LUCANU-2

Details and patient eligibility

About

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

Full 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)

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Intervention group

Experimental group

Description:

2 g EPA/DHA via fish oil daily Regular dietary counselling Twice weekly strength and cardiovascular exercise

Treatment:

Other: multimodal

Historical control group

No Intervention group

Description:

Standard of Care