Multimodal Intervention for Patients With Non-small Cell Lung Cancer

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

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

Study Overview

• Status: Completed
• Conditions: Cachexia; Cancer
• Intervention / Treatment: Other: multimodal

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)

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; 2 g EPA/DHA via fish oil daily Regular dietary counselling Twice weekly strength and cardiovascular exercise	Other: multimodal; 2 g EPA/DHA as fish oil, repeated dietary counselling and twice weekly 2 x exercises
NO_INTERVENTION: Historical control group; Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility, recruitment rate	Recruitment rate is measured by dividing the number of patients consented by the number of patients screened	9 months
Feasibility, retention rate	Retention rate is measured by dividing the number of patients completing the trial with the number of patients consented	9 months
Feasibility, compliance	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	9-18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive and prognostic factors of change in skeletal muscle	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.	9-18 weeks
Group difference in body weight	The change in body weight (measured at baseline and at the end of the trial using body weight scales, expressed as %	9-18 weeks
Group difference in skeletal muscle	Change in skeletal muscle (measured using CT scans, expressed as actual muscle change at the 3rd lumbar vertebra in mean (SD) cm^2	9-18 weeks
Proportion of patients gaining, maintaining and wasting of skeletal muscle	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	9-18 weeks
Change in physical function	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).	9-18 weeks

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Study Chair: Mette Holst, PhD, Aalborg University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2018
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): April 30, 2019

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (ACTUAL): November 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 11, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: cancer; cachexia; multimodal intervention
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Wasting Syndrome; Cachexia
• Other Study ID Numbers: LUCANU-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No