Clinical trial NCT02330926: Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
Official title: A Randomised, Open-label Trial of a Multimodal Intervention (Exercise, Nutrition and Antiinflammatory Medication) Plus Standard Care Versus Standard Care Alone to Prevent/Attenuate Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cachexia
Neoplasms
Keywords: Combined modality treatment
Diet therapy
Exercise therapy
Ibuprofen
Dietary supplements
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Oslo University Hospital
name: Cantonal Hospital of St. Gallen
name: Ottawa Regional Cancer Centre
name: Jewish General Hospital
name: Cross Cancer Institute
name: The Beatson West of Scotland Cancer Centre
name: Queen Margaret Hospital, Dunfermline
name: Cancer Research UK Edinburgh Centre
name: Malteser Krankenhaus Seliger Gerhardt
name: Tumor Biology Center Freiburg
name: Tumor Zentrum Aarau
name: Chelsea and Westminster NHS Foundation Trust
name: Cedars-Sinai Medical Center
name: Guy's and St Thomas' NHS Foundation Trust
name: NHS Forth Valley
First posted: 2015-01-05
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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)
* completed all other baseline assessments within one week prior to first course of anti-cancer treatment
* written informed consent
* able to comply with trial interventions (in the opinion of referring clinician) e.g. willing and able to do light exercise and take oral nutritional supplements as well as no major contraindications against ibuprofen.
* Karnofsky Performance Status \>70

Exclusion Criteria:

* Neuro-endocrine pancreatic cancer
* Creatinine clearance \<30ml/min
* Receiving parenteral nutrition or enteral nutrition via feeding tube
* receiving neo-adjuvant anti-cancer therapy
* BMI \>30 kg/m2
* Use of appetite stimulants or anabolic/anti-catabolic agents (such as megestrol acetate, progestational agents, marijuana growth hormone, dronabinol, or other anabolic agent) within 30 days prior to study baseline
* Concomitant steroid (\>10mg/d prednisolone or equivalent) treatment for less than three months prior to inclusion (inhaled, optical or pulsed oral steroids (up to 10 days use) are permitted)
* Concomitant long term (\>1 week) nonsteroidal anti-inflammatory drugs (NSAID) or aspirin treatment
* pregnancy, breast-feeding or of child bearing potential (that is not postmenopausal or permanently sterilised) age and not using adequate contraception (oral, injected, implanted or hormonal methods of contraception, intrauterine device and barrier method)
* Concomitant anti-coagulant treatment (e.g. warfarin or heparin)

Primary outcomes:
measure: change in body weight
timeFrame: 6 weeks
Secondary outcomes:
measure: change in muscle mass
timeFrame: 6 weeks
measure: change in physical activity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Brampton
country: Canada
facility: CA4 Brampton Civic Hospital
city: Edmonton
country: Canada
facility: Cross Cancer Insitute
city: Montréal
country: Canada
facility: Jewish General Hospital
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Aarau
country: Switzerland
facility: Tumor Zentrum
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital
city: Larbert
country: United Kingdom
facility: NHS Forth Valley
state: Falkirk
city: Dunfermline
country: United Kingdom
facility: Queen Margaret Hospital
state: Fife
city: Cardiff
country: United Kingdom
facility: Llandough Hospital
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: Chelsea and Westminister Hospital NHS
city: London
country: United Kingdom
facility: Guys and St Thomas
Study officials:
affiliation: European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, NTNU, Trondheim, Norway
name: Stein Kaasa, MD PhD
role: STUDY_DIRECTOR
affiliation: Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK
name: Marie Fallon, MD PhD
role: STUDY_DIRECTOR
References:
citation: Solheim TS, Laird BJA, Balstad TR, Bye A, Stene G, Baracos V, Strasser F, Griffiths G, Maddocks M, Fallon M, Kaasa S, Fearon K. Cancer cachexia: rationale for the MENAC (Multimodal-Exercise, Nutrition and Anti-inflammatory medication for Cachexia) trial. BMJ Support Palliat Care. 2018 Sep;8(3):258-265. doi: 10.1136/bmjspcare-2017-001440. Epub 2018 Feb 9.
citation: Naito T. Challenges in enhancing physical performance in thoracic cancer cachexia. Thorac Cancer. 2021 Oct;12(20):2633-2634. doi: 10.1111/1759-7714.14154. Epub 2021 Sep 15. No abstract available.