CancerLITENCT01780623
An Investigation of Light Therapy for Cancer-related Fatigue (The LITE Study)
A study testing Bright white light and Dim red light in people with Cancer, run by University of Calgary at 1 site in Canada.
Trial summary
Cancer-related fatigue is one of the most common and distressing symptoms associated with a cancer diagnosis.Fatigue related to cancer often appears before a diagnosis, worsens during treatment, and lasts for years after treatment in up to 35% of patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer
- What is being tested?
- Bright white light and Dim red light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Apr 2015
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Non metastatic cancer
- At least 3 months post chemotherapy/radiation treatment (hormone treatment ok)
- Meets criteria for cancer-related fatigue
Who cannot join
- Under 18 years of age
- Presence of a sleep disorder other than insomnia or hypersomnia
- Shift work
- Presence of an Axis-I psychiatric condition
- Presence of a medical condition that may impact levels of fatigue
- Presence of conditions contraindicated to the use of light therapy or photosensitizing medications
- Randomization refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Light Therapy on Biomarkers, Sleep/Wake Activity, and Quality of Life in Individuals With Post-treatment Cancer-related Fatigue
Cancer-related fatigue is one of the most common and distressing symptoms associated with a cancer diagnosis.Fatigue related to cancer often appears before a diagnosis, worsens during treatment, and lasts for years after treatment in up to 35% of patients. Despite the long-term effects of cancer-related fatigue, the treatment options available are not always appropriate or helpful for all patients.Light therapy is an effective treatment for other disorders related to fatigue. The purpose of the study is to investigate the role of light therapy on quality of life, sleep patterns, and physical measures of immune function and stress hormones in individuals with post-treatment cancer-related fatigue.
- Conditions
- Cancer
- Being tested
- Bright white light, Dim red light
- Keywords
- fatigue, sleep, quality of life, light, cancer
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright white lightDevice
Also called Light box, LiteBook
Dim red lightDevice
Also called Light box, LiteBook
| Study group | Role | What they receive |
|---|---|---|
| Bright White Light | Experimental | Bright white light exposure every morning for 30 minutes for 28 consecutive days Receives: Device: Bright white light |
| Dim Red Light | Active comparator | Dim red light exposure every morning for 30 minutes for 28 consecutive days Receives: Device: Dim red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue symptoms from baseline to post-treatment
Measured: Baseline, after each treatment week (each week for 4 weeks), and at week 5
Secondary outcomes (8)
Change in objective measures of sleep using wrist actigraphy from baseline to post-treatment
Measured: Baseline (for 7 days), week 5 (for 7 days)
Change in subjective measures of sleep using sleep diaries from baseline to post-treatment
Measured: Baseline (for 7 days), week 5 (for 7 days)
Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment
Measured: Baseline, week 5
Change in Profile of Mood States scores from baseline to post-treatment
Measured: Baseline, week 5
Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment
Measured: Baseline, week 5
Change in salivary cortisol from baseline to post-treatment
Measured: Baseline (for 3 days), week 5 (for 3 days)
Change in inflammatory cytokines from baseline to post-treatment
Measured: Baseline, week 5
Change in Insomnia Severity Index scores from baseline to post-treatment
Measured: Baseline, week 3, week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Tavis S. Campbell, University of Calgary
- Investigators
- Tavis S Campbell, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780623
- Sponsor's protocol ID
- 10003569
- Acronym
- LITE
- Status last verified
- Apr 2016
- First submitted
- 22 Jan 2013
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson JA, Subnis U, Carlson LE, Garland SN, Santos-Iglesias P, Piedalue KL, Deleemans JM, Campbell TS. Effects of a light therapy intervention on diurnal salivary cortisol in fatigued cancer survivors: A secondary analysis of a randomized controlled trial. J Psychosom Res. 2020 Dec;139:110266. doi: 10.1016/j.jpsychores.2020.110266. Epub 2020 Oct 6.
PubMed 33070045
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Light Therapy on Biomarkers, Sleep/Wake Activity, and Quality of Life in Individuals With Post-treatment Cancer-related Fatigue
- ClinicalTrials.gov ID
- NCT01780623
- Acronym / sponsor ID
- LITE / 10003569
- Conditions
- Cancer
- Keywords
- fatigue, sleep, quality of life, light, cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- Jan 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 31 Jan 2013 (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 is one of the most common and distressing symptoms associated with a cancer diagnosis.Fatigue related to cancer often appears before a diagnosis, worsens during treatment, and lasts for years after treatment in up to 35% of patients. Despite the long-term effects of cancer-related fatigue, the treatment options available are not always appropriate or helpful for all patients.Light therapy is an effective treatment for other disorders related to fatigue. The purpose of the study is to investigate the role of light therapy on quality of life, sleep patterns, and physical measures of immune function and stress hormones in individuals with post-treatment cancer-related fatigue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright White Light | Experimental | Device: Bright white lightBright white light exposure every morning for 30 minutes for 28 consecutive days |
| Dim Red Light | Active comparator | Device: Dim red lightDim red light exposure every morning for 30 minutes for 28 consecutive days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- Non metastatic cancer
- At least 3 months post chemotherapy/radiation treatment (hormone treatment ok)
- Meets criteria for cancer-related fatigue
Key exclusion criteria (7 listed)
- Under 18 years of age
- Presence of a sleep disorder other than insomnia or hypersomnia
- Shift work
- Presence of an Axis-I psychiatric condition
- Presence of a medical condition that may impact levels of fatigue
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 |
|---|---|---|
| Bright white lightAlso: Light box, LiteBook | Device | Bright White Light |
| Dim red lightAlso: Light box, LiteBook | Device | Dim Red Light |
Primary outcome
Change in fatigue symptoms from baseline to post-treatment
Time frame: Baseline, after each treatment week (each week for 4 weeks), and at week 5
8 secondary outcomes
Change in objective measures of sleep using wrist actigraphy from baseline to post-treatment
Time frame: Baseline (for 7 days), week 5 (for 7 days)
Change in subjective measures of sleep using sleep diaries from baseline to post-treatment
Time frame: Baseline (for 7 days), week 5 (for 7 days)
Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment
Time frame: Baseline, week 5
Change in Profile of Mood States scores from baseline to post-treatment
Time frame: Baseline, week 5
Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment
Time frame: Baseline, week 5
Change in salivary cortisol from baseline to post-treatment
Time frame: Baseline (for 3 days), week 5 (for 3 days)
Change in inflammatory cytokines from baseline to post-treatment
Time frame: Baseline, week 5
Change in Insomnia Severity Index scores from baseline to post-treatment
Time frame: Baseline, week 3, week 5
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 8 Apr 2016.
- Derived from this study: PubMed 33070045Johnson JA, Subnis U, Carlson LE, Garland SN, Santos-Iglesias P, Piedalue KL, Deleemans JM, Campbell TS. Effects of a light therapy intervention on diurnal salivary cortisol in fatigued cancer survivors: A secondary analysis of a randomized controlled trial. J Psychosom Res. 2020 Dec;139:110266. doi: 10.1016/j.jpsychores.2020.110266. Epub 2020 Oct 6.
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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.
Tavis S Campbell, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright white light and Dim red light in people with Cancer, run by University of Calgary at 1 site in Canada.
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 7 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 8 Apr 2016. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in fatigue symptoms from baseline to post-treatment (time frame: Baseline, after each treatment week (each week for 4 weeks), and at week 5). 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 NCT01780623, which also lists 1 linked publication.
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 8 Apr 2016.