A Feasibility Study of Multimodal Exercise/Nutrition/Anti-inflammatory Treatment for Cachexia - the Pre-MENAC Study

Norwegian University of Science and Technology

Status: Completed

Conditions: Cachexia; Cancer

Treatments: Other: Multimodal intervention; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT01419145

2010-022897-14 (EudraCT Number)

2010/2620 (REK)

Details and patient eligibility

About

A multicentre, open, randomized phase II study comparing a multimodal intervention (oral nutritional supplements, celecoxib and physical exercise) for cachexia versus standard cancer care.

Enrollment: 46 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main eligibility criteria:

• Advanced non-small-cell lung cancer (stage III-IV) or pancreatic cancer not eligible for curative therapy
• Due to commence chemo- or chemo radiotherapy
• Karnofsky Performance Score ≥ 70
• A life expectancy of ≥4 months and considered able to complete 2 months of the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Multimodal intervention

Experimental group

Treatment:

Other: Multimodal intervention

Standard Care

Active Comparator group

Treatment:

Other: Standard care