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NCT Number: NCT04161794

Multimodal Intervention for Patients With Non-small Cell Lung Cancer

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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Key information

Conditions

Cachexia; Cancer Body Weight Body Weight Changes Cachexia Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg Univeristy Hospital

Aalborg, 9000, Denmark

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal

Other

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

Primary outcomes

  1. Feasibility, recruitment rate

    Time frame: 9 months

    Recruitment rate is measured by dividing the number of patients consented by the number of patients screened

  2. 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

  3. 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

Secondary outcomes

  1. Predictive and prognostic factors of change in skeletal muscle

    Time frame: 9-18 weeks

    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.

  2. Group difference in body weight

    Time frame: 9-18 weeks

    The change in body weight (measured at baseline and at the end of the trial using body weight scales, expressed as %

  3. Group difference in skeletal muscle

    Time frame: 9-18 weeks

    Change in skeletal muscle (measured using CT scans, expressed as actual muscle change at the 3rd lumbar vertebra in mean (SD) cm^2

  4. Proportion of patients gaining, maintaining and wasting of skeletal muscle

    Time frame: 9-18 weeks

    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

  5. Change in physical function

    Time frame: 9-18 weeks

    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).

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Multimodal Intervention (Dietary Counselling, Fish Oil and Physical Training) for Patients With Non-small Cell Lung Cancer, a Feasibility Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2019
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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