Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
(MENAC Trial)

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Norwegian University of Science and Technology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?Cancer cachexia is a multi-factorial syndrome defined by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment. There is an urgency for improving management, but there is no consensus on the optimal treatment for cancer cachexia. Several single therapies for cancer cachexia have been examined in clinical trials, with disappointing overall results. As multiple factors are responsible for the development of cachexia, it has been argued that optimal cachexia interventions should target all components: multimodal therapy for a multimodal problem. The overall aim of this study is to early prevent the development of cachexia rather than treatment late in the disease trajectory. From a patient perspective a short term effect will be to improve physical and psychological function, to reduce symptom burden and to improve survival. In other words live a longer and better life during and after chemotherapy. Direct effects of the cachexia intervention are expected to be reduction of weight and muscle loss, and improved physical activity and quality of life.

Eligibility Criteria

Inclusion Criteria

Diagnosis of lung cancer, pancreatic cancer or cholangiocarcinoma where the diagnosis is based on histological, radiological or multidisciplinary team (MDT) evaluation

non-small cell lung cancer (stage III or IV), pancreatic adenocarcinoma (stage III or IV), due to commence first or second line anticancer treatment (defined as chemotherapy, chemo-radiotherapy, targeted therapy or immunotherapy)

staging CT within 4 weeks of commencement of anti-cancer therapy (in patients where staging CT is out-with this period, further CT scanning will be undertaken. PETCT's are also appropriate)

+4 more

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: multimodal interventionExperimental Treatment4 Interventions

standard care plus multimodal intervention consisting of nutritional supplements and advice, home-based self-assisted exercise program, and anti-inflammatory medication (ibuprofen)

Group II: standard careActive Control1 Intervention

standard palliative care