NCT01440621

Brief Summary

Cancer related fatigue (CRF) is a highly prevalent and highly significant entity among patients with cancer. 'Cancer related fatigue' is not a simple symptom, but is an entity in itself, in that it is different from routine fatigue. Cancer related fatigue is that fatigue which persists even after rest and has significant effects on quality of life. The incidence of Cancer Related Fatigue (CRF) increases during radiation therapy (RT), with almost every patient on radiotherapy complaining of at-least some magnitude of fatigue. Given that fatigue can affect treatment adherence by patients, it is important to initiate measures to either prevent or mitigate Cancer Related Fatigue. The investigators intend to use modafinil in cancer related fatigue, in view of the fact that it has safety and efficacy in other diseases such as narcolepsy, multiple sclerosis and fibromyalgia. In addition, there have been a few small trials which have hinted towards benefit with the use of modafinil in cancer related fatigue. The investigators have chosen a dose of 100mg/day in the morning, to be compared with placebo. The study arm and the placebo arm will be stratified with respect to age, sex, disease site, baseline performance status. Primary outcome would be fatigue, which will be assessed by the use of Brief Fatigue Inventory (BFI). Secondary outcomes include Quality of Life, improvements in performance status, changes in systolic and diastolic blood pressure, and changes in weight.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 23, 2012

Status Verified

March 1, 2012

Enrollment Period

1.5 years

First QC Date

September 20, 2011

Last Update Submit

March 21, 2012

Conditions

Cancer Related FatigueQuality of Life

Keywords

Cancer related fatigueQuality of lifeModafinilRadiation therapyRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • Reduction in Cancer Related Fatigue

    Changes in Fatigue measured with the Brief Fatigue Inventory (BFI).

    Baseline and 12 weeks

Secondary Outcomes (4)

  • Improvement in Quality of Life

    Baseline and 12 weeks

  • Karnofsky Performance Status Scores

    Baseline and 12 weeks

  • Effects of Modafinil on Systolic and Diastolic Blood Pressure

    Baseline and 12 weeks

  • Changes in weight

    Baseline and 12 weeks

Study Arms (2)

Arm M

ACTIVE COMPARATOR

Will be treated with Tab Modafinil (generic) 100mg Once a Day in the Morning starting from Day 1 of RT till the first follow-up.

Drug: Modafinil

Arm P

PLACEBO COMPARATOR

Will be given placebo (Tab Pyridoxine 10mg) which physically resembles Tab Modafinil 100mg.

Drug: Pyridoxine

Interventions

ModafinilDRUG

Tablet Modafinil 100mg (Generic) to be given in 100mg once a day dose, at 8AM daily in the morning, and to be given from Day 1 of Radiation Therapy till the first post treatment follow-up

Arm M
PyridoxineDRUG

Tablet Pyridoxine 10mg once a day at 8AM daily, from Day one of RT till first post-treatment followup. Tab Pyridoxine 10mg has been chosen as placebo as it resembles Tab Modafinil 100mg in physical appearance, size and shape. Tab Pyridoxine is unlikely to affect Cancer Related Fatigue on its own as all patients on RT are already on multivitamin supplements as per our institutional guidelines.

Arm P

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pathological confirmation of cancer
  • Age 18 years to 70 years
  • Performance status (Karnofsky scale) not less than 60
  • Providing consent

You may not qualify if:

  • Psychiatric illness
  • Hypertension
  • Diabetes
  • Thyroid disorders
  • Epilepsy
  • Tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Cancer Centre

Shimla, Himachal Pradesh, 171001, India

Location

Related Publications (5)

  • Spathis A, Dhillan R, Booden D, Forbes K, Vrotsou K, Fife K. Modafinil for the treatment of fatigue in lung cancer: a pilot study. Palliat Med. 2009 Jun;23(4):325-31. doi: 10.1177/0269216309102614. Epub 2009 Mar 6.

    PMID: 19270033RESULT

  • Cooper MR, Bird HM, Steinberg M. Efficacy and safety of modafinil in the treatment of cancer-related fatigue. Ann Pharmacother. 2009 Apr;43(4):721-5. doi: 10.1345/aph.1L532. Epub 2009 Mar 24.

    PMID: 19318599RESULT

  • Blackhall L, Petroni G, Shu J, Baum L, Farace E. A pilot study evaluating the safety and efficacy of modafinal for cancer-related fatigue. J Palliat Med. 2009 May;12(5):433-9. doi: 10.1089/jpm.2008.0230.

    PMID: 19416039RESULT

  • Wirz S, Nadstawek J, Kuhn KU, Vater S, Junker U, Wartenberg HC. [Modafinil for the treatment of cancer-related fatigue : an intervention study]. Schmerz. 2010 Dec;24(6):587-95. doi: 10.1007/s00482-010-0987-y. German.

    PMID: 21046171RESULT

  • Jean-Pierre P, Morrow GR, Roscoe JA, Heckler C, Mohile S, Janelsins M, Peppone L, Hemstad A, Esparaz BT, Hopkins JO. A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the effect of modafinil on cancer-related fatigue among 631 patients receiving chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology Program Research base study. Cancer. 2010 Jul 15;116(14):3513-20. doi: 10.1002/cncr.25083.

    PMID: 20564068RESULT

Related Links

MeSH Terms

Interventions

ModafinilPyridoxine

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsVitamin B 6PicolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-Graduate in Radiation Oncology

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 26, 2011

Study Start

August 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 23, 2012

Record last verified: 2012-03

Locations

IN(1)