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

The Effect of Peri-surgery Blue and Amber Light Exposure in Subjects Undergoing Medical and Surgical Treatment of Cancer

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06164691
Enrollment
2
Registered
2023-12-11
Start date
2022-08-14
Completion date
2023-04-29
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms, Rectal Neoplasms

Brief summary

This study will evaluate light therapy used in combination with standard therapies for pancreatic and rectal cancer. Participants will receive chemotherapy, radiation, and surgical treatments identical to that they had not been involved in the study. The only alteration is that some participants will be exposed additionally to either blue or amber light using commercially available seasonal affective disorder (SAD) lights that are approved for human use. Participants will use the SAD light in their own homes throughout the course of their radiation and chemotherapy treatments. They will wear goggles that filter with the desired color of light. As a comparison, another group of participants will be exposed only to their usual lighting conditions. The assignment to blue light, amber light, or usual light groups will be random. In addition to the light exposure, participants will be asked to have 10 mL of blood drawn for research purposes at 4 time points. This blood will be analyzed for markers of inflammation and circadian clock activation. Participants also will be asked to complete surveys at 3 time points. These surveys will evaluate for effects changs in sleep, pain, and quality of life. Finally, participants will be asked to wear a small clip-on light sensor and a heart rate variability monitor for 7 days. These monitors will provide information on the level of light exposure and the participant's physiologic response to the light. For participants going on to surgery, we will obtain a small sample of the resected pancreas or rectal tumor for research analysis. The investigators will obtain this sample only after the necessarily analysis has been performed for their clinical care.

Detailed description

The investigators incorporate appropriate control participants, which include participants who are matched for stage and age and who undergo neoadjuvant chemoradiation and/or surgery but who are not exposed to modulation of their environmental light. There are no deviations from the standard of care for these patients. They will be receiving care identical to that had they not been involved in this study. The only alteration is that some participants will be exposed additionally to either blue or amber light. The investigators use commercially available seasonal affective disorder (SAD) lights that are already approved for therapeutic human use. These lights are small and portable and approved for use for seasonal affective disorder (SAD). The investigators have used them in other human trials and have not identified any adverse or unexpected events. The participants will be asked to have 10 mL of blood drawn for research purposes at 4 time points to assess for markers of the inflammatory response and circadian clock activation. Additionally, they will be asked to complete surveys at 3 time points to assess for quality-of-life measures. They will be asked to wear a small light sensor and a heart rate variability monitor for 7 days to measure the adequacy of light exposure and physiologic response to the exposure, respectively. In the participants who undergo definitive operative resection (e.g., Whipple (pancreaticoduodenectomy) procedure, mesorectal proctectomy), we will analyze a sample of the resected specimen. The investigators will obtain this sample only after complete pathological examination and reporting in accordance with best practices of care. Thus, the sample being acquired for research purposes is discarded biological tissue and no additional sampling is performed. In fact, there are absolutely no deviations or interference with the processes of delivering care.

Interventions

Participants undergoing this intervention will be exposed to blue (442nm) light.

DEVICEAmber light

Participants undergoing this intervention will be exposed to amber (617nm) light.

OTHERAmbient White Light

This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments

Sponsors

Matthew Neal MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomization will achieved with block randomization on the following characteristics: 1. Type of cancer: group 1: pancreatic cancer; group 2: rectal cancer. 2. Stage of cancer as defined by Tumor Node Metastasis classification. b. Age (\<55 years, \>/= 55 years)

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. greater than 18 and less than 80 years of age 2. adenocarcinoma of the pancreas (unresectable) or adenocarcinoma of the rectum (stage II or III).

Exclusion criteria

1. Prior chemotherapy (inability to determine the integrity of the immune response) 2. Autoimmune disorder, immunosuppression therapy, or immunocompromised state (inability to determine the integrity of the immune response) 3. Blindness or other significant vision disorder or prior traumatic brain injury (the inability to determine the integrity of functional optic and suprachiasmatic pathways) 4. Hematological disease - e.g., myelodysplastic syndrome, leukemia (inability to determine the integrity of the immune response) 5. Bipolar disorder or schizophrenia (potential heightened symptoms) 6. Refusal/ineligible to undergo neoadjuvant chemotherapy and/or radiation

Design outcomes

Primary

MeasureTime frameDescription
Clinical Complete ResponseSix monthsRate of complete response to neoadjuvant chemoradiation upon restaging

Secondary

MeasureTime frameDescription
Pain ControlSix monthsThe Brief Pain Inventory (BPI) - Lowest score: 0 (lowest pain severity, least interference with function), Highest score: 10 (greatest pain severity, most interference with function).
Quality of Life as Determined by WHO QOL Survey.Six monthsThe World Health Organization Quality of Life Brief Version - WHOQOL-Bref: scores calculated for each of four domains: physical, psychological, social, and environmental - Lowest score: 4 (very dissatisfied), Highest score: 20 (very satisfied).
Functional StatusSix monthsThe Karnofsky Performance Scale - Lowest score 0% (dead), Highest score 100% (normal; no complaints, no evidence of disease)
Weight LossSix monthsChange in BMI will be used as a marker of nutritional status.
Sleep QualitySix monthsThe 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).
Immune ModulationSix monthsCytokine levels (IL-10,IL-6)
Chemoradiation ToleranceSix monthsPercentage of planned chemoradiation completed
Prealbumin LevelSix monthsChange in prealbumin level will be used as a measure of nutritional status
Circadian ActivationSix monthsRev-erb alpha concentration

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
2
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.
0
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
0
Total2

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyWithdrawal by Subject200

Baseline characteristics

CharacteristicTotalBlue LightAmbient White LightAmber Light
Age, Continuous68.5 years
STANDARD_DEVIATION 7.78
68.5 years
STANDARD_DEVIATION 7.78
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants
Race (NIH/OMB)
White
2 Participants2 Participants
Region of Enrollment
United States
2 participants2 participants
Sex: Female, Male
Female
1 Participants1 Participants0 Participants0 Participants
Sex: Female, Male
Male
1 Participants1 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 20 / 00 / 0
other
Total, other adverse events
0 / 20 / 00 / 0
serious
Total, serious adverse events
0 / 20 / 00 / 0

Outcome results

Primary

Clinical Complete Response

Rate of complete response to neoadjuvant chemoradiation upon restaging

Time frame: Six months

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

Secondary

Chemoradiation Tolerance

Percentage of planned chemoradiation completed

Time frame: Six months

Population: No data collected.

Secondary

Circadian Activation

Rev-erb alpha concentration

Time frame: Six months

Population: No data collected.

Secondary

Functional Status

The Karnofsky Performance Scale - Lowest score 0% (dead), Highest score 100% (normal; no complaints, no evidence of disease)

Time frame: Six months

Population: No data collected.

Secondary

Immune Modulation

Cytokine levels (IL-10,IL-6)

Time frame: Six months

Population: No data collected.

Secondary

Pain Control

The Brief Pain Inventory (BPI) - Lowest score: 0 (lowest pain severity, least interference with function), Highest score: 10 (greatest pain severity, most interference with function).

Time frame: Six months

Population: No data collected.

Secondary

Prealbumin Level

Change in prealbumin level will be used as a measure of nutritional status

Time frame: Six months

Population: No data collected.

Secondary

Quality of Life as Determined by WHO QOL Survey.

The World Health Organization Quality of Life Brief Version - WHOQOL-Bref: scores calculated for each of four domains: physical, psychological, social, and environmental - Lowest score: 4 (very dissatisfied), Highest score: 20 (very satisfied).

Time frame: Six months

Population: No data collected.

Secondary

Sleep Quality

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).

Time frame: Six months

Population: No data were collected.

Secondary

Weight Loss

Change in BMI will be used as a marker of nutritional status.

Time frame: Six months

Population: No data collected.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026