Trial Outcomes & Findings for Blue and Amber Light Exposure in Patients With Rectal and Pancreatic Cancer (NCT NCT06164691)

Results Overview

Rate of complete response to neoadjuvant chemoradiation upon restaging

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Six months

Results posted on

2024-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Blue Light This cohort will be exposed to bright (1700 lux) blue (peak 442 nm) light for 4 hours each morning for 3 days prior to and 3 days following each chemotherapy infusion.They will be exposed to bright (1700 lux) blue (peak 442 nm) light for 1 hour each morning during radiation treatments. Blue light: Participants undergoing this intervention will be exposed to blue (442nm) light.	Amber Light This cohort will be exposed to bright (1700 lux) amber (peak 617 nm) light for 4 hours each morning for 3 days prior to and 3 days following each chemotherapy infusion.They will be exposed to bright (1700 lux) amber (peak 617 nm) light for 1 hour each morning during radiation treatments Amber light: Participants undergoing this intervention will be exposed to amber (617nm) light.	Ambient White Light This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments. Ambient White Light: This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments
Overall Study STARTED	2	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Blue Light This cohort will be exposed to bright (1700 lux) blue (peak 442 nm) light for 4 hours each morning for 3 days prior to and 3 days following each chemotherapy infusion.They will be exposed to bright (1700 lux) blue (peak 442 nm) light for 1 hour each morning during radiation treatments. Blue light: Participants undergoing this intervention will be exposed to blue (442nm) light.	Amber Light This cohort will be exposed to bright (1700 lux) amber (peak 617 nm) light for 4 hours each morning for 3 days prior to and 3 days following each chemotherapy infusion.They will be exposed to bright (1700 lux) amber (peak 617 nm) light for 1 hour each morning during radiation treatments Amber light: Participants undergoing this intervention will be exposed to amber (617nm) light.	Ambient White Light This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments. Ambient White Light: This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments
Overall Study Withdrawal by Subject	2	0	0

Baseline Characteristics

Blue and Amber Light Exposure in Patients With Rectal and Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blue Light n=2 Participants This cohort will be exposed to bright (1700 lux) blue (peak 442 nm) light for 4 hours each morning for 3 days prior to and 3 days following each chemotherapy infusion.They will be exposed to bright (1700 lux) blue (peak 442 nm) light for 1 hour each morning during radiation treatments. Blue light: Participants undergoing this intervention will be exposed to blue (442nm) light.	Amber Light This cohort will be exposed to bright (1700 lux) amber (peak 617 nm) light for 4 hours each morning for 3 days prior to and 3 days following each chemotherapy infusion.They will be exposed to bright (1700 lux) amber (peak 617 nm) light for 1 hour each morning during radiation treatments Amber light: Participants undergoing this intervention will be exposed to amber (617nm) light.	Ambient White Light This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments. Ambient White Light: This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments	Total n=2 Participants Total of all reporting groups
Age, Continuous	68.5 years STANDARD_DEVIATION 7.78 • n=99 Participants	—	—	68.5 years STANDARD_DEVIATION 7.78 • n=7 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants	—	—	2 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Region of Enrollment United States	2 participants n=99 Participants	—	—	2 participants n=7 Participants

PRIMARY outcome

Timeframe: Six months

Population: Trial was terminated before the outcome measure data were collected.

Rate of complete response to neoadjuvant chemoradiation upon restaging

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Six months

Population: No data were collected.

The Pittsburgh Sleep Quality Index (PSQI) - seven component scores on scale 0-3 are summed for a total score: Lowest score: 0 (best sleep quality), Highest score: 21 (worst sleep quality).