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

NCT06164691 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-05-21

Study results available
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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.

Conditions

  • Pancreatic Neoplasms
  • Rectal Neoplasms

Interventions

DEVICE

Blue light

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

DEVICE

Amber light

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

OTHER

Ambient White Light

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

Sponsors & Collaborators

  • Matthew Neal MD

    lead OTHER

Principal Investigators

  • Matthew Neal, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-14
Primary Completion
2023-04-29
Completion
2023-04-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06164691 on ClinicalTrials.gov