Multimodal Intervention for Patients With Non-small Cell Lung Cancer

Cachexia; Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161794
• Other study ID #: LUCANU-2
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: November 2019
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• Cachexia; Cancer

Intervention

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

Locations

Country	Name	City	State
Denmark	Aalborg Univeristy Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, recruitment rate	Recruitment rate is measured by dividing the number of patients consented by the number of patients screened	9 months
Primary	Feasibility, retention rate	Retention rate is measured by dividing the number of patients completing the trial with the number of patients consented	9 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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