Clinical trial NCT06164691: Blue and Amber Light Exposure in Patients With Rectal and Pancreatic Cancer
Official title: The Effect of Peri-surgery Blue and Amber Light Exposure in Subjects Undergoing Medical and Surgical Treatment of Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Neoplasms
Rectal Neoplasms
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 2
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Complete Response
timeFrame: Six months
Secondary outcomes:
measure: Sleep Quality
timeFrame: Six months
measure: Pain Control
timeFrame: Six months
measure: Quality of Life as Determined by WHO QOL Survey.
timeFrame: Six months
measure: Functional Status
timeFrame: Six months
measure: Weight Loss
timeFrame: Six months
measure: Circadian Activation
timeFrame: Six months
measure: Immune Modulation
timeFrame: Six months
measure: Chemoradiation Tolerance
timeFrame: Six months
measure: Prealbumin Level
timeFrame: Six months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Matthew Neal, MD
role: PRINCIPAL_INVESTIGATOR
References: