A study examining a combination of treatments (exercise, diet advice and anti-inflammatory medication) in the treatment of weight loss, fatigue and poor appetite in cancer

Phase 1

• Conditions: Non-operable stage III/IV non-small cell lung cancer Pancreatic cancer; MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10025052 Term: Lung cancer non-small cell stage III System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10033604 Term: Pancreatic cancer System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022897-14-GB
• Lead Sponsor: Greater Glasgow Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-04
• Study Completion: 2014-09-01
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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 chemotherapy or chemoradiotherapy
3.Have a staging CT within 4 weeks of commencement of chemotherapy or chemoradiotherapy
4.All baseline assessments can be completed within 2 weeks prior to first cycle of chemotherapy or chemoradiotherapy
5.18–75 years of age
6.A life expectancy of =4 months and is believed to be able to complete 2 months of intervention (based on clinical judgement)
7.Karnofsky Performance Score = 70
8.Written informed consent
9.Able to provide a blood sample

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1.Neuro-endocrine pancreatic cancer
2.Renal impairment(serumalbumin < 25 g/L eller Child-Pugh =10), creatinine clearance <30ml/min (estimated using cockcroft-gault, creatinine measured within two months of date of consent)
3.Receiving parenteral nutrition or enteral nutrition via feeding tube
4.Weight loss >20% over the previous 6 months
5.BMI >30 kg/m2
6.Severe anorexia (less than 50% pre-illness food intake and unable to take oral supplements)
7.Use of appetite stimulants (such as megestrol acetate, progestational agents, growth hormone, dronabinol, marijuana or other anabolic agent) within 30 days prior to study baseline
8.Concomitant long term steroid treatment (inhaled, optical or pulsed oral steroids (up to 10 days use) are permitted).
9.Concomitant long term NSAID or Aspirin treatment.
10.Regularly scheduled on kinase inhibitors (e.g. sorafinib)
11.Women during pregnancy, breastfeeding or who are in child-bearing age and do not use adequate contraception
12.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
13.Previous gastrointestinal inflammatory disease and history of gastrointestinal ulceration
14.History of bronchospasm, asthma, rhinitis, nasal polyps, angioneurotic oedema or urticaria with intake of NSAID or aspirin therapy
15.History of hyper sensibility related to intake of acetylsalisylsyre or NSAIDs, including COX-2 (cyklooksygenase-2) inhibitors.
16.History of hyper sensibility to Sulphonamides
17.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