Bright Light Therapy (called BLT) for Fatigue

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
MD Anderson Cancer Center, Houston, TX
Fatigue+6 More
Melatonin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

To learn if Cognitive Behavior Therapy (called CBT), combined with either Bright Light Therapy (called BLT), methylphenidate, and/or melatonin, can help improve sleep and other related symptoms such as fatigue, anxiety, and depression in cancer patients. This is an investigational study. In this study, BLT, Methylphenidate and Melatonin will be compared to their placebos.

Eligible Conditions

  • Sleep
  • Fatigue
  • Anxiety
  • Malignancies
  • Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Through the study completion, an average of 1 year.

Year 1
Pittsburgh Sleep Quality Index (PSQI) questionnaires
Year 1
Edmonton Symptom Assessment System (ESAS) questionnaires

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

8 Treatment Groups

Bright Light Therapy (called BLT)
1 of 8
Methylphenidate
1 of 8
Melatonin
1 of 8
Cognitive Behavior Therapy (called CBT)
1 of 8
Bright light and Melatonin (BLT + MT+ placebo MP with CBT)
1 of 8
Methylphenidate (CLT + placebo MT + MP with CBT)
1 of 8
Combination Therapy (BLT+MT+MP with CBT)
1 of 8
Placebo (CLT+ placebo MT + placebo MP with CBT)
1 of 8
Experimental Treatment

188 Total Participants · 8 Treatment Groups

Primary Treatment: Bright Light Therapy (called BLT) · Has Placebo Group · Phase 2 & 3

Bright Light Therapy (called BLT)
Behavioral
Experimental Group · 1 Intervention: Bright Light Therapy · Intervention Types: Behavioral
Methylphenidate
Drug
Experimental Group · 1 Intervention: Methylphenidate · Intervention Types: Drug
Melatonin
Drug
Experimental Group · 1 Intervention: Melatonin · Intervention Types: Drug
Cognitive Behavior Therapy (called CBT)
Behavioral
Experimental Group · 1 Intervention: Cognitive Behavior Therapy · Intervention Types: Behavioral
Bright light and Melatonin (BLT + MT+ placebo MP with CBT)Experimental Group · 2 Interventions: Placebo for Melatonin, Methylphenidate · Intervention Types: Other, Drug
Methylphenidate (CLT + placebo MT + MP with CBT)
Drug
Experimental Group · 1 Intervention: Melatonin · Intervention Types: Drug
Combination Therapy (BLT+MT+MP with CBT)Experimental Group · 3 Interventions: Placebo for Melatonin, Melatonin, Methylphenidate · Intervention Types: Other, Drug, Drug
Placebo (CLT+ placebo MT + placebo MP with CBT)Experimental Group · 2 Interventions: Placebo for Melatonin, Melatonin · Intervention Types: Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150
Methylphenidate
2014
Completed Phase 4
~432010
Cognitive Behavior Therapy
2010
Completed Phase 3
~2360
Bright Light Therapy
2010
Completed Early Phase 1
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through the study completion, an average of 1 year.
Closest Location: MD Anderson Cancer Center · Houston, TX
Photo of MD Anderson Cancer Center  1Photo of MD Anderson Cancer Center  2Photo of MD Anderson Cancer Center  3
2004First Recorded Clinical Trial
1 TrialsResearching Fatigue
520 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are cognitively competent to respond appropriately to questions, as measured by the Memorial Delirium Assessment Scale.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.