Intervention investigating the effect of the combination of ibuprofen, oral nutritional supplement(with EPA) and exercise in attenuating cancer cachexia
- Conditions
- nintentional weight loss , cachexia, increases chemotherapy toxicity and reduces survival and quality of life. There is no treatment available today. Based on knowledge of cachexia pathophysiology and previous single intervention studies, we now investigate in a RCT trial if multimodal cachexia intervention(nutritional therapy with EPA, physical exercise and anti-inflammatory treatment(ibuprofen))+standard treatment improves weight and physical performance better than standard treatment alone.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-002282-19-DE
- Lead Sponsor
- European Palliative Care Research Centre (PRC), NT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
1. Diagnosis of lung cancer or pancreatic cancer where the diagnosis is based on histological, radiological or multidisciplinary team (MDT) evaluation
2. Patients with non-small cell lung cancer (stage III or IV) or pancreatic adenocarcinoma (stage III or IV) due to commence first or second line anticancer treatment (defined as chemotherapy or chemo-radiotherapy or targeted therapy
3. Have a 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. PET-CT’s are also appropriate)
4. Have completed all other baseline assessments within one week prior to first course of anti-cancer treatment
5. Provide written informed consent
6. Able to comply with trial interventions (in the opinion of referring clinician) e.g. willing and able to do light exercise and take ONS as well as no major contraindications against ibuprofen*.
7. Karnofsky Performance Status =70
8. = 18 years of age
9. Femal patients of childbearing potential must have a negative pregnancy test performed during screening period.
*The use of proton-pump inhibitor should be decided upon by the physician in charge of the patient if the patient has a history of dyspepsia or gastric ulcer. If the patient has had a recent gastric ulcer the patient is not eligible as she/he has a major contraindication to ibuprofen
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
1. Neuro-endocrine pancreatic cancer
2. Creatinine clearance <30ml/min.**
3. Receiving parenteral nutrition or enteral nutrition via feeding tube
4. Patients receiving neo-adjuvant anti-cancer therapy
5. BMI >30 kg/m2
6. 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
7. 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)
8. Concomitant long term (>1 week) NSAID or Aspirin treatment***
9. 9.Women during pregnancy, breast-feeding or women of child bearing potential , who are not using or not willing to use highly effective methods of contraception**** for the entire study duration unless they are surgically sterilized / hysterectomized.
10. Concomitant anti-coagulant treatment (e.g. warfarin or heparin)
11. Hypersensitivity to Ibuprofen or any of the constituents in Ibuprofen tablets
12.Patients who have previously shown hypersensitivity reaction (e.g. asthma, rhinitis, angioedema or urticarial) in response to aspirin or other non-steroidal anti-inflammatory drugs
13.Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
14.History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
15.Patients with conditions involving an increased tendency to bleeding
16.Severe hepatic failure, renal failure or severe heart failure (NYHA Class IV)
17.Patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
** Patients who are receiving pemetrexed and have mild to moderate renal insufficiency (Creatinine Clearance 45-79 ml/min) should not take ibuprofen for 2 days before, on the day of and 2 days after pemetrexed administration.
*** Patients who are taking aspirin, NSAID or Cox 2 inhibitors prior to study entry can participate in the study providing these medications are either permanently or temporarily stopped during trial participation. This should only be done following discussion with the clinician responsible for the patient’s general care – usually general practitioner or family physician. In patients who are taking other medication which may interact with ibuprofen, e.g. fluconazole, the risks/benefits of these medications should be considered and discussed with the study physician, prior to patient recruitment.
**** Highly effective contraceptive methods (Pearl Index <1) are:
•combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
ooral
ointravaginal
otransdermal
•progestogen-only hormonal contraception associated with inhibition of ovulation:
ooral
oinjectable
oimplantable
•intrauterine device
•intrauterine hormone-releasing system
•vasectomized partne
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method