Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing... | Recruiting
Multimodal Intervention for Cachexi... | Recruiting
Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
MENAC

Location not identified by Google services

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Cachexia
  • Neoplasms
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02330926
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Other : standard care, Other : nutritional supplements and advice, Other : home-based self-assisted exercise program, Drug : Ibuprofen

Study Arm Groups : multimodal intervention, standard care, multimodal intervention, multimodal intervention, multimodal intervention

Intervention Type
See Interventions above
Primary Outcome Measures
    change in body weight; 6 weeks
Secondary Outcome Measures
    change in muscle mass; 6 weeks; change in physical activity; 6 weeks
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
240
Participant Inclusion 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), small cell lung cancer (extensive stage) or pancreatic adenocarcinoma (stage III or IV) or non-operable cholangiocarcinoma, due to commence first or second line anticancer treatment (defined as chemotherapy or chemo-radiotherapy or targeted therapy

    - 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)
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Glasgow
Central
Local Institution
London
Greater London
Edinburgh
Cardiff
Research Site
Fife
Trial Contact(s)
Primary Trial Contact
Trude R Balstad, PhD
Other Trial Contacts
Tora S Solheim, MD PhD
Countries Recruiting
Canada, Germany, Norway, Switzerland, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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
EudraCT Number
Not available for this trial
Funder(s)
  • St. Olavs Hospital
  • Oslo University Hospital
  • Cantonal Hospital of St. Gallen
  • Ottawa Regional Cancer Centre
  • Jewish General Hospital
  • Cross Cancer Institute
  • The Beatson West of Scotland Cancer Centre
  • Queen Margaret Hospital, Dunfermline
  • Cancer Research UK Edinburgh Centre
  • Malteser Krankenhaus Seliger Gerhardt
  • Tumor Biology Center Freiburg
  • Tumor Zentrum Aarau
Other Study ID Numbers
MENAC-2013-05
Sponsor(s)
Norwegian University of Science and Technology
Key Dates

Recruitment Start Date

Apr 2015

Recruitment End Date

Jan 2019

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

31 Dec 2014

Date updated in source

27 Feb 2018