Modafinil for the Treatment of Fatigue in Lung Cancer V1.0 - Full Text View

Sponsor:	University of Oxford
Information provided by:	University of Oxford
ClinicalTrials.gov Identifier:	NCT00829322

Purpose

Fatigue is a persistent, subjective sense of tiredness, which interferes with a person's usual ability to function. It is believed to be both the most common and the most distressing symptom experienced by those with cancer. Despite the magnitude of the problem, there has been inadequate research into the management of cancer-related fatigue.

Central nervous system (CNS) stimulants are the only class of drug established as being directly effective in relieving fatigue. Traditional stimulants, such as methylphenidate (Ritalin), can cause side-effects such as difficulty sleeping at night and anxiety. Modafinil is a relatively new stimulant with few side-effects. There is increasing evidence that modafinil can reduce fatigue in healthy individuals and patients with chronic, non-cancer conditions. No good quality studies have been published evaluating modafinil in patients with cancer, despite multiple calls for such research to be undertaken.

The investigators have just completed a small study to determine the feasibility of undertaking a larger, high quality study to assess the effect of modafinil on fatigue in patients with lung cancer. Modafinil appeared to improve fatigue rapidly and was not associated with serious side-effects. Ten of the fifteen patients who completed the study chose to continue modafinil long-term. However, the study was too small for definite conclusions to be drawn.

This larger, definitive study, funded by a National Cancer Research Institute research award, will establish more clearly whether modafinil can improve fatigue in patients with lung cancer. Two hundred and six patients will be recruited from eight sites in England. Half of the patients will take modafinil, and the other half will take a 'dummy' tablet every day for a month. The fatigue levels of the two groups will be compared. Confirmation that modafinil can relieve cancer-related fatigue could have a highly significant impact on the quality of life of the very large number of patients suffering from this common and distressing symptom.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Modafinil Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Modafinil for the Treatment of Fatigue in Lung Cancer: a Multicentre, Randomised, Double-Blinded, Placebo-Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Modafinil

U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:

The fatigue subscale of the Functional Assessment of Chronic Illness Therapy measurement system [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Epworth Sleepiness Scale [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Hospital Anxiety and Depression Scale [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Quality of life linear analogue scale [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	206
Study Start Date:	February 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment group: Experimental	Drug: Modafinil Modafinil 100mg once daily for 14 days, increasing to 200mg once daily for a further 14 days
Control group: Placebo Comparator	Drug: Placebo One capsule daily for 14 days, increasing to two capsules daily for 14 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participant is willing and able to give informed consent for participation in the study
Male or female, aged 18 years or above
Diagnosed with NSCLC with confirmatory histology or cytology
Stage 3b or stage 4 disease, or recurrent disease after surgery
WHO performance status of 0-2
Participant has a screening score of 5 or more in a 10-point numerical rating scale (NRS) of fatigue severity within two weeks of enrolment
Able (in the investigator's opinion) and willing to comply with all study requirements, including ability to participate for in study for 28 days
Willing to allow his or her General Practitioner to be notified of participation in the study.

Exclusion Criteria:

Received radiotherapy or chemotherapy within the last 4 weeks
Commenced on antidepressants or steroids (corticosteroids and progestational steroids) within the last 2 weeks
Received blood transfusion within the last 2 weeks
Potentially fertile woman of child-bearing age
Major anxiety requiring intervention in secondary care
History of arrhythmia requiring medical intervention
Uncontrolled hypertension with blood pressure greater than 160/100 mmHg
History of cor pulmonale or left ventricular hypertrophy
Currently taking warfarin
Previous adverse reaction to modafinil or other CNS stimulant
Scheduled elective surgery or other procedures requiring general anaesthesia during the study
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
Currently participating in another research study involving an investigational product.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829322

Locations

United Kingdom
Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Christie Hospital
Manchester, United Kingdom, M20 4BX
Royal Marsden Hospital
London, United Kingdom, SM25PT
Papworth Hospital
Papworth Everard, United Kingdom, CB23 3RE
Stoke Mandeville Hospital
Aylesbury, United Kingdom, HP21 8AL
Peterborough District Hospital
Peterborough, United Kingdom, PE3 6DA
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
St George's Hospital
London, United Kingdom, SW17 0RE

Sponsors and Collaborators

University of Oxford

More Information

No publications provided

Responsible Party:	University of Oxford ( Heather House )
Study ID Numbers:	Modafinil/lung/01
Study First Received:	January 26, 2009
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00829322 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Physiological Effects of Drugs
Central Nervous System Stimulants
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Modafinil
Carcinoma

Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Central Nervous System Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 09, 2010