Anti-inflammatory and nutritional support, with simple exercises in lung cancer patients with weight loss.

Completed

• Conditions: Cancer cachexia; Cancer - Lung - Non small cell; Diet and Nutrition - Other diet and nutrition disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12611000870954
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Patients who have diagnosed NSCLC and have received at least a first-line anti-cancer treatment e.g. surgery, chemotherapy, radiotherapy or a targeted therapy (i.e. gefitinib, erlotinib and crizotinib) and fulfil the following cachexia definition Q1 Has lost 5% of oedema-free body weight in the previous 12 months or less Q2 Mild less than or equal to 5%, Moderate greater than 10%, Severe greater than 15% Q3 If no documented weight loss, Is BMI of less than 20.0 kg/m2 Q4 At least 3 out of the following 5 1. Decreased muscle strength 2. Experiencing fatigue either measured by a VO2 max score or patient confirmed reduced physical activity 3. Anorexia 4. Low fat-free mass index (low muscle mass) 5. Abnormal biochemistry, CRP greater than 5.0mg/L IL-6 greater than 4.0pg/ml anaemia Hb less than 12.0g/dL hypoalbuminemia less than 3.2g/dL 1.Patients greater than or equal to 18 years old 2.Histologically confirmed non-small cell carcinoma of the lung. (Histological or cytological specimens must be collected via surgical biopsy, brushing, washing or core needle aspiration of a defined lesion. Sputum cytology is not acceptable) 3.Patients should be aware of the diagnosis of cancer 4. Patients able to give written informed consent obtained according to local guidelines 5.Fulfils above ‘cachectic definition’ 6.Karnofsky Scoreequal to 60 or ECOG Performance Status 0,1, 2 or 3 7.Recently completed first-line platinum-based chemotherapy 8.Lab values within the range, as defined below, within 2 weeks of randomisation: 1. Absolute neutrophils count (ANC) greater than 2.0 x 109/L 2. Platelets greater than or equal to 100 x 109/L 3. Haemoglobin greater than or equal to 100 g/dL 4. Serum creatinine less than or equal to 1.5 x ULN (= 120 micro mol/L) 5. Serum bilirubin less than or equal to 1.5 x ULN (= 25 micro mol/L) 6. Aspartate transaminase (AST) and alanine transaminase (ALT)less than or equal to 2.5 x ULN (less than or equal to 5 x ULN if liver metastases) 7. Electrolyte values (potassium, calcium, magnesium) within greater than 1 x LLN and less than 1 x ULN 8. Females of child-bearing potential must have negative serum pregnancy test (confirmation of negative urine pregnancy test within 72 hours prior to initial dosing) 9.Life expectancy greater or equal to 20 weeks

Exclusion Criteria

1.Patients who are, in the opinion of a doctor or nurse in the department, unlikely to be suitable to participate by virtue of mental incapacity, severe current psychological or psychiatric disorder
2.Patients with an estimated prognosis of less than one month
3.Concurrent use of other investigational agents and patients who have received investigational agents in the last 4 weeks prior to randomisation
4.Concurrent use of other appetite stimulants e.g. MPA or MA and 4mg OD dexamethasone or 30mg OD prednisolone
5.Patients with systolic BP > 160 mm HG and/or diastolic > 90 mm HG
6.Pleural effusion that causes a CTC grade 2 dyspnoea
7.Radiotherapy in the last 2 weeks prior to randomisation. Patients must have recovered from all radiotherapy-related toxicities
8.Patients with a history of another primary malignancy within last 5 years with the exception of non-melanoma skin cancer or cervical cancer in situ
9.Patients having CNS metastases (Patients having any clinical signs of CNS metastases must have a CT or MRI of the brain performed to rule out CNS metastases in order to be eligible for study participation. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed)
10.Patients with recent haemoptysis associated with NSCLC (> 1 teaspoon in a single episode within 4 weeks)
11.Patients with an abnormal Baseline 12-lead ECG
12.Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal failure, chronic liver disease
Patient unwilling or unable to comply with the study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: The acceptability of the treatment regimen will be assessed by asking patients to complete a questionnaire asking if they found the regimen acceptable and if they wish to continue with the treatment.[Timepoint: at visit 5 / week 12 and End of Study visit]