PreMENAC: Multimodal Exercise/Nutrition/Anti-inflammatory treatment for Cachexia: A feasibility study (phase II) - Pre - MENAC

Phase 1

• Conditions: Diagnosis of non operable non-small cell lung cancer NSCLC (stage III-IV) or pancreatic cancer

• Registration Number: EUCTR2010-022897-14-NO
• Lead Sponsor: Dep. of Cancer Research and Molecular medicine, Norwegian University of Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-18
• Study Completion: 2014-09-01
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1.Diagnosis of non operable non-small cell lung cancer NSCLC (stage III-IV) or pancreatic cancer
2.Due to commence systematic chemotherapy or combination chemo-radiotherapy.
3.Have a staging CT within 3 weeks of commencement of systemic chemotherapy/chemo-radiotherapy at study baseline
4.18–75 years of age
5.A life expectancy of =4 months and is believed to be able to complete 2 months of intervention (based on clinical judgement)
6.Karnofsky Performance Score = 70
7.Written informed consent
8.Able to provide a blood sample

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Renal impairment, creatinin clearance <30ml/min (estimated using cockroft-gault, creatinine measured within two months of date of consent)
2.Receiving parenteral nutrition or enteral nutrition via feeding tube
3.Weight loss >20% over the previous 6 months
4.BMI >30 kg/m2
5.Severe anorexia (less than 50% pre-illness food intake and unable to take oral supplements)
6.Stated taking appetite stimulants such as megestrol acetate, progestational agents, steroids, growth hormone, dronabinol, marijuana or other anabolic agents
7.Concomitant long term steroid treatment (inhaled, optical steroids or pulsed dexamethasone is permitted)
8.Concomitant long term NSAID or Aspirin treatment.
9.Regularly scheduled on kinase inhibitors (e.g. sorafinib)
10.Women of child-bearing age who not using adequate contraception
11.Positive history of heart disease, i.e., severe (New York Heart Association Functional class III or IV) heart failure, uncontrolled hypertension (diastolic blood pressure >95 mmHg at screening), history of previous myocardial infarction, unstable angina, coronary revascularization, uncontrolled arrhythmia, and cerebrovascular accident
12.Previous gastrointestinal inflammatory disease and history of gastrointestinal ulceration
13.History of bronchospasm, asthma, rhinitis, or urticaria with NSAID or aspirin therapy
14.Ongoing/planned radiotherapy during the study period affecting the gastric/oesophagus area

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified