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Modafinil for the Treatment of Fatigue in Lung Cancer V9.0

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT00829322
First received: January 26, 2009
Last updated: August 16, 2013
Last verified: August 2013
  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 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 a number of sites across the UK. 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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modafinil for the Treatment of Fatigue in Lung Cancer: a Multicentre, Randomised, Double-blinded, Placebo-controlled Trial

Resource links provided by NLM:


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 ]
  • Adverse events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 208
Study Start Date: February 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group Drug: Modafinil
Modafinil 100mg once daily for 14 days, increasing to 200mg once daily for a further 14 days
Placebo Comparator: Control group 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
  • Stage 3a, 3b or stage 4 disease, or recurrent disease after surgery or radiotherapy
  • 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 an EGFR tyrosine kinase inhibitors eg Gefitinib and Erlotinib within the last 6 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
Stoke Mandeville Hospital
Aylesbury, United Kingdom
Macclesfield District Hospital
Cheshire, United Kingdom
University Hospital of North Tees
County Durham, United Kingdom
Basildon and Thurrock University Hospitals
Essex, United Kingdom
Basingstoke and North Hampshire Hospital
Hampshire, United Kingdom
East Kent University Hospitals
Kent, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, United Kingdom
University Hospital
Llandough, United Kingdom
Royal Marsden Hospital Fulham Road
London, United Kingdom
Royal Marsden Hospital Sutton
London, United Kingdom
St George's Hospital
London, United Kingdom
Christie Hospital
Manchester, United Kingdom
Wythenshawe Hospital
Manchester, United Kingdom
James Cook University Hospital
Middlesborough, United Kingdom
Harrogate and District NHS Foundation Trust
North Yorkshire, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Papworth Hospital
Papworth Everard, United Kingdom
Withybush General Hospital
Pembrokeshire, United Kingdom
Peterborough District Hospital
Peterborough, United Kingdom
Royal Surrey County Hospital
Surrey, United Kingdom
Great Western Hospital
Swindon, United Kingdom
Hillingdon Hospital
Uxbridge, United Kingdom
Calderdale and Huddersfield NHS Foundation Trust
West Yorkshire, United Kingdom
Mid Yorkshire Hospital NHS Trust
West Yorkshire, United Kingdom
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Bee Wee, PhD University of Oxford
  More Information

No publications provided by University of Oxford

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT00829322     History of Changes
Other Study ID Numbers: Modafinil/lung/09
Study First Received: January 26, 2009
Last Updated: August 16, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Armodafinil
Modafinil
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on November 20, 2014