Multimodal Intervention for Patients With Non-small Cell Lung Cancer

NCT04161794 | Completed

• 1 other identifier: LUCANU-2
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cachexia; Cancer

Keywords

cachexia; cancer; multimodal intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Predictive and prognostic factors of change in skeletal muscle

  9-18 weeks

• Group difference in body weight

  9-18 weeks

• Group difference in skeletal muscle

  9-18 weeks

• Proportion of patients gaining, maintaining and wasting of skeletal muscle

  9-18 weeks

• Change in physical function

  9-18 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: multimodal

Historical control group

NO INTERVENTION

Standard of Care

Interventions

multimodal OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• excessive alcohol or drug abuse
• incapable to follow the intervention (i.e. cognitive problems or unable to walk) were excluded.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg Univeristy Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32600857 DERIVED

MeSH Terms

Conditions

Cachexia; Neoplasms

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mette Holst, PhD

  Aalborg University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Non-randomised
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. student

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

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: November 13, 2019
• Study Start: February 15, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)