Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy (MENAC)
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| ClinicalTrials.gov Identifier: NCT02330926 |
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Recruitment Status :
Recruiting
First Posted : January 5, 2015
Last Update Posted : January 31, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cachexia Neoplasms | Other: standard care Other: nutritional supplements and advice Other: home-based self-assisted exercise program Drug: Ibuprofen | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 240 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | April 2015 |
| Estimated Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: multimodal intervention
standard care plus multimodal intervention consisting of nutritional supplements and advice, home-based self-assisted exercise program, and anti-inflammatory medication (ibuprofen)
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Other: standard care Other: nutritional supplements and advice Other: home-based self-assisted exercise program Drug: Ibuprofen |
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Active Comparator: standard care
standard palliative care
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Other: standard care |
- change in body weight [ Time Frame: 6 weeks ]
- change in muscle mass [ Time Frame: 6 weeks ]
- change in physical activity [ Time Frame: 6 weeks ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330926
| Contact: Trude R Balstad, PhD | trude.r.balstad@ntnu.no | ||
| Contact: Tora S Solheim, MD PhD | tora.l.skeidsvoll@ntnu.no |
Show 17 study locations
| Study Director: | Stein Kaasa, MD PhD | European Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Faculty of Medicine, NTNU, Trondheim, Norway | |
| Study Director: | Marie Fallon, MD PhD | Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, UK |
| Responsible Party: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT02330926 |
| Other Study ID Numbers: |
MENAC-2013-05 2013-002282-19 ( EudraCT Number ) |
| First Posted: | January 5, 2015 Key Record Dates |
| Last Update Posted: | January 31, 2020 |
| Last Verified: | January 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Combined modality treatment Diet therapy Exercise therapy Ibuprofen Dietary supplements |
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Wasting Syndrome Cachexia Emaciation Weight Loss Body Weight Changes Body Weight Signs and Symptoms Metabolic Diseases Nutrition Disorders Ibuprofen Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |