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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06164691
• Other study ID #: STUDY22060036
• Status: Terminated
• Phase: N/A
• Start date: August 14, 2022
• Est. completion date: April 29, 2023

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 29, 2023
• Est. primary completion date: April 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Pancreatic Neoplasms
• Rectal Neoplasms

Intervention

Device:
• Blue light
Participants undergoing this intervention will be exposed to blue (442nm) light.
• 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

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Matthew Neal MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Complete Response	Rate of complete response to neoadjuvant chemoradiation upon restaging	Six months
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).	Six months
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).	Six months
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).	Six months
Secondary	Functional Status	The Karnofsky Performance Scale - Lowest score 0% (dead), Highest score 100% (normal; no complaints, no evidence of disease)	Six months
Secondary	Weight Loss	Change in BMI will be used as a marker of nutritional status.	Six months
Secondary	Circadian Activation	Rev-erb alpha concentration	Six months
Secondary	Immune Modulation	Cytokine levels (IL-10,IL-6)	Six months
Secondary	Chemoradiation Tolerance	Percentage of planned chemoradiation completed	Six months
Secondary	Prealbumin Level	Change in prealbumin level will be used as a measure of nutritional status	Six months