Multimodal Intervention for Patients With Non-small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2019-04-30

Brief Summary

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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

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Detailed Description

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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

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Cachexia; Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

This is a single arm intervention study, comparing the results to that of a historical control Group.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Non-randomised

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

multimodal

Intervention Type OTHER

2 g EPA/DHA as fish oil, repeated dietary counselling and twice weekly 2 x exercises

Historical control group

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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multimodal

2 g EPA/DHA as fish oil, repeated dietary counselling and twice weekly 2 x exercises

Intervention Type OTHER

Eligibility Criteria

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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