Trial Outcomes & Findings for Effect of Increased Light Exposure on Fatigue in Breast Cancer (NCT NCT00478257)

NCT ID: NCT00478257

Last Updated: 2019-02-06

Results Overview

The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is -24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: four cycles of chemotherapy
• Results posted on: 2019-02-06

Participant Flow

Participant milestones

Measure	Effect of Bright Light Effect of bright light on fatigue in women with breast cancer	Effect of Red Light effect of red light on fatigue in women with breast cancer
Overall Study STARTED	23	16
Overall Study COMPLETED	15	13
Overall Study NOT COMPLETED	8	3

Reasons for withdrawal

Measure	Effect of Bright Light Effect of bright light on fatigue in women with breast cancer	Effect of Red Light effect of red light on fatigue in women with breast cancer
Overall Study Withdrawal by Subject	8	3

Baseline Characteristics

Effect of Increased Light Exposure on Fatigue in Breast Cancer

Baseline characteristics by cohort

Measure	Effect of Bright Light n=23 Participants Effect of bright light on fatigue in women with breast cancer	Effect of Red Light n=16 Participants effect of red light on fatigue in women with breast cancer	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	54.3 years STANDARD_DEVIATION 9 • n=5 Participants	53.5 years STANDARD_DEVIATION 9 • n=7 Participants	53.9 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	16 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	16 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: four cycles of chemotherapy

Population: All participants that were randomized and began the protocol were included in analyses.

The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is -24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.

Outcome measures

Measure	Effect of Bright Light n=23 Participants Effect of bright light on fatigue in women with breast cancer	Effect of Red Light n=16 Participants effect of red light on fatigue in women with breast cancer
Fatigue	15.25 units on a scale Standard Error 5.5	21.6 units on a scale Standard Error 7.2

Adverse Events

Effect of Bright Light

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Effect of Red Light

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sonia Ancoli-Israel

UCSD

Phone: 858 642-7710

Email: sancoliisrael@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place