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

NCT06164691 | Terminated Results FDA Device

• 1 other identifier: STUDY22060036
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms; Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Clinical Complete Response

  Rate of complete response to neoadjuvant chemoradiation upon restaging

  Six months

Secondary Outcomes (9)

• Sleep Quality

  Six months

• Pain Control

  Six months

• Quality of Life as Determined by WHO QOL Survey.

  Six months

• Functional Status

  Six months

• Weight Loss

  Six months

Study Arms (3)

Blue light

EXPERIMENTAL

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

Amber light

EXPERIMENTAL

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

Ambient white light

ACTIVE COMPARATOR

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

Other: Ambient White Light

Interventions

Blue light DEVICE

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

Blue light

Amber light DEVICE

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

Amber light

Ambient White Light OTHER

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

Ambient white light

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Matthew Neal MD: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr. Matthew Neal
• Organization: University of Pittsburgh

nealm2@upmc.edu

412-647-1158

Study Officials

• Matthew Neal, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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)

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: August 14, 2022
• Primary Completion: April 29, 2023
• Study Completion: April 29, 2023
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 12 months and ending 36 months following article publication.
• 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.

Locations

US (1)