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

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.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Neoplasms; Rectal Neoplasms
• Intervention / Treatment: Device: Blue light; Device: Amber light; Other: Ambient White Light

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa M. Vavro, BSN; Phone Number: 412-951-4664; Email: vavrolm@upmc.edu
• Study Contact Backup: Name: Rebecca Kotcher, MD; Email: kotcherre@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. greater than 18 and less than 65 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Blue light; Participants undergoing this intervention will be exposed to blue (442nm) light.
Experimental: 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	Device: Amber light; Participants undergoing this intervention will be exposed to amber (617nm) light.
Active Comparator: Ambient white light; This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments.	Other: Ambient White Light; This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Complete Response	Rate of complete response to neoadjuvant chemoradiation upon restaging	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Six months
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).	Six months
Quality of life	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).	Six months
Functional status	The Karnofsky Performance Scale - Lowest score 0% (dead), Highest score 100% (normal; no complaints, no evidence of disease)	Six months
Weight Loss	Change in BMI will be used as a marker of nutritional status.	Six months
Circadian activation	Rev-erb alpha concentration	Six months
Immune modulation	Cytokine levels (IL-10,IL-6)	Six months
Chemoradiation tolerance	Percentage of planned chemoradiation completed	Six months
Prealbumin Level	Change in prealbumin level will be used as a measure of nutritional status	Six months

Collaborators and Investigators

• Sponsor: Matthew Neal MD
• Investigators: Principal Investigator: Matthew Neal, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2022
• Primary Completion (Actual): April 29, 2023
• Study Completion (Actual): April 29, 2023

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Pancreatic Diseases; Neoplasms; Rectal Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: STUDY22060036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data after de-identification will be shared. A data dictionary will also be made available. Data will be available beginning 12 months and ending 36 months following article publication. Data will be shared with those researchers who provide a methodologically sound proposal. Only those data necessary to achieve the aims in the approved proposal will be shared. Proposals should be directed to the corresponding author and will undergo approval by the investigative team. To gain access after proposal approval, data requestors will need to sign a data access agreement. Data will be available for 1 year after proposal approval.
• IPD Sharing Time Frame: Data will be available beginning 12 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Researcher will provide a proposal to the corresponding author by email or written letter and the proposal will undergo approval by the investigative team. A data access agreement will be required.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes