E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The symptom of fatigue in patients with non-small cell lung cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029514 |
E.1.2 | Term | Non-small cell lung cancer NOS |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The principal objective of this study is to determine whether modafinil can reduce the level of fatigue experienced by patients with lung cancer. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are as follows: 1) To check that modafinil is safe in patients with lung cancer and does not cause intolerable side-effects 2) To help determine which dose of modafinil should be used for the treatment of fatigue in this patient group 3) To evaluate the effect of modafinil on daytime sleepiness and depression in lung cancer patients |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Participant is willing and able to give informed consent for participation in the study 2) Male or female, aged 18 years or above 3) Diagnosed with non-small cell lung Cancer 4) Stage 3a, 3b or stage 4 disease, or recurrent disease after surgery or radiotherapy 5) World Health Organisation performance status of 0-2 6) Screening score of 5 or more in a 10-point numerical rating scale of fatigue severity within two weeks of enrolment 7) Able (in the investigator’s opinion) and willing to comply with all study requirements, including ability to participate for in study for 28 days 8) Willing to allow his or her General Practitioner to be notified of participation in the study.
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E.4 | Principal exclusion criteria |
The participant may not enter the study if ANY of the following apply: 1) Received radiotherapy or chemotherapy within the last 4 weeks 2) Started on an EGFR tyrosine kinase inhibitor e.g. Gefitinib (Iressa®) and Erlotinib (Tarceva®) within the last 6 weeks. 2) Commenced on antidepressants or steroids (corticosteroids and progestational steroids) within the last 2 weeks 3) Received blood transfusion within the last 2 weeks 4) Potentially fertile woman of child-bearing age 5) Major anxiety requiring intervention in secondary care 6) History of arrhythmia requiring medical intervention 7) Uncontrolled hypertension with blood pressure greater than 160/100 mmHg 8) History of cor pulmonale or left ventricular hypertrophy 9) Currently taking warfarin 10) Previous adverse reaction to modafinil or other CNS stimulant 11) Scheduled elective surgery or other procedures requiring general anaesthesia during the study 12) Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or affect the participant’s ability to participate in the study 13) Currently participating in another research study involving an investigational product.
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E.5 End points |
E.5.1 | Primary end point(s) |
The difference in fatigue score between the treatment (modafinil) group and the placebo group, after 28 days of taking the study intervention |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |