Cancer Related FatiguePhase 3ModCRFNCT01440621
Modafinil in Cancer Related Fatigue
A Phase 3 study testing Modafinil and Pyridoxine in people with Cancer Related Fatigue and Quality of Life, run by Indira Gandhi Medical College, Shimla at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer Related Fatigue, Quality of Life
- What is being tested?
- Modafinil and Pyridoxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2010to Feb 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathological confirmation of cancer
- Age 18 years to 70 years
- Performance status (Karnofsky scale) not less than 60
- Providing consent
Who cannot join
- Psychiatric illness
- Hypertension
- Diabetes
- Thyroid disorders
- Epilepsy
- Tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy
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.
Read more
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.
- Conditions
- Cancer Related Fatigue, Quality of Life
- Being tested
- Modafinil, Pyridoxine
- Keywords
- Cancer related fatigue, Quality of life, Modafinil, Radiation therapy, Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Modafinil |
| Arm P | Placebo comparator | Will be given placebo (Tab Pyridoxine 10mg) which physically resembles Tab Modafinil 100mg. Receives: Drug: Pyridoxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Cancer Related Fatigue
Changes in Fatigue measured with the Brief Fatigue Inventory (BFI).
Measured: Baseline and 12 weeks
Secondary outcomes (4)
Improvement in Quality of Life
The Spitzer Quality of Life Index (SQLI) to obtain Quality of Life (QOL) measurements.
Measured: Baseline and 12 weeks
Karnofsky Performance Status Scores
Performance status scores measured with the Karnofsky Performance Status (KPS) scale.
Measured: Baseline and 12 weeks
Effects of Modafinil on Systolic and Diastolic Blood Pressure
Measured: Baseline and 12 weeks
Changes in weight
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startAug 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cancer Related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indira Gandhi Medical College, Shimla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swaroop Revannasiddaiah, Indira Gandhi Medical College, Shimla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440621
- Sponsor's protocol ID
- ModCRF
- Acronym
- ModCRF
- Status last verified
- Mar 2012
- First submitted
- 20 Sep 2011
- Last updated
- 23 Mar 2012
- Results posted
- No
Publications
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.
PubMed 19270033Cooper 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.
PubMed 19318599Blackhall 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.
PubMed 19416039Wirz 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.
PubMed 21046171Jean-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.
PubMed 20564068
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study to Evaluate the Effects of Modafinil in Cancer Related Fatigue in Patients Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT01440621
- Acronym / sponsor ID
- ModCRF / ModCRF
- Conditions
- Cancer Related Fatigue, Quality of Life
- Keywords
- Cancer related fatigue, Quality of life, Modafinil, Radiation therapy, Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Indira Gandhi Medical College, ShimlaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm M | Active comparator | Drug: ModafinilWill be treated with Tab Modafinil (generic) 100mg Once a Day in the Morning starting from Day 1 of RT till the first follow-up. |
| Arm P | Placebo comparator | Drug: PyridoxineWill be given placebo (Tab Pyridoxine 10mg) which physically resembles Tab Modafinil 100mg. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with pathological confirmation of cancer
- Age 18 years to 70 years
- Performance status (Karnofsky scale) not less than 60
- Providing consent
Key exclusion criteria (6 listed)
- Psychiatric illness
- Hypertension
- Diabetes
- Thyroid disorders
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModafinilTablet 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 | Drug | Arm M |
| PyridoxineTablet 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. | Drug | Arm P |
Primary outcome
Reduction in Cancer Related Fatigue
Time frame: Baseline and 12 weeks
Changes in Fatigue measured with the Brief Fatigue Inventory (BFI).
4 secondary outcomes
Improvement in Quality of Life
Time frame: Baseline and 12 weeks
Karnofsky Performance Status Scores
Time frame: Baseline and 12 weeks
Effects of Modafinil on Systolic and Diastolic Blood Pressure
Time frame: Baseline and 12 weeks
Changes in weight
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
- Results publication: PubMed 19270033Spathis 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.
- Results publication: PubMed 19318599Cooper 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.
- Results publication: PubMed 19416039Blackhall 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.
- Results publication: PubMed 21046171Wirz 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.
- Results publication: PubMed 20564068Jean-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.
- Link to a trial which utilized modafinil as an intervention for cancer related fatigue in 631 patients of breast cancer undergoing chemoLink provided by the sponsor.
- A small study which showed that modafinil was well-tolerated and effective for fatigue in patients with cancer.Link provided by the sponsor.
- A study which called for randomized trials with modafinil in cancer related fatigueLink provided by the sponsor.
- Link to an article validating the Brief Fatigue Inventory (scale for fatigue assessment).Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modafinil and Pyridoxine in people with Cancer Related Fatigue and Quality of Life, run by Indira Gandhi Medical College, Shimla at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Cancer Related Fatigue (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01440621, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2012.