Pancreatic Neoplasms, Rectal Neoplasms
Conditions
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.
Interventions
Participants undergoing this intervention will be exposed to blue (442nm) light.
Participants undergoing this intervention will be exposed to amber (617nm) light.
This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments
Sponsors
Study design
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)
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Complete Response | Six months | Rate of complete response to neoadjuvant chemoradiation upon restaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Control | Six months | 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). |
| Quality of Life as Determined by WHO QOL Survey. | Six months | 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). |
| Functional Status | Six months | The Karnofsky Performance Scale - Lowest score 0% (dead), Highest score 100% (normal; no complaints, no evidence of disease) |
| Weight Loss | Six months | Change in BMI will be used as a marker of nutritional status. |
| Sleep Quality | Six months | 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). |
| Immune Modulation | Six months | Cytokine levels (IL-10,IL-6) |
| Chemoradiation Tolerance | Six months | Percentage of planned chemoradiation completed |
| Prealbumin Level | Six months | Change in prealbumin level will be used as a measure of nutritional status |
| Circadian Activation | Six months | Rev-erb alpha concentration |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Blue light: Participants undergoing this intervention will be exposed to blue (442nm) light. | 2 |
| 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
Amber light: Participants undergoing this intervention will be exposed to amber (617nm) light. | 0 |
| Ambient White Light This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments.
Ambient White Light: This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments | 0 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Blue Light | Ambient White Light | Amber Light |
|---|---|---|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 7.78 | 68.5 years STANDARD_DEVIATION 7.78 | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | — | — |
| Region of Enrollment United States | 2 participants | 2 participants | — | — |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 2 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 | 0 / 0 |
Outcome results
Clinical Complete Response
Rate of complete response to neoadjuvant chemoradiation upon restaging
Time frame: Six months
Population: Trial was terminated before the outcome measure data were collected.
Chemoradiation Tolerance
Percentage of planned chemoradiation completed
Time frame: Six months
Population: No data collected.
Circadian Activation
Rev-erb alpha concentration
Time frame: Six months
Population: No data collected.
Functional Status
The Karnofsky Performance Scale - Lowest score 0% (dead), Highest score 100% (normal; no complaints, no evidence of disease)
Time frame: Six months
Population: No data collected.
Immune Modulation
Cytokine levels (IL-10,IL-6)
Time frame: Six months
Population: No data collected.
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).
Time frame: Six months
Population: No data collected.
Prealbumin Level
Change in prealbumin level will be used as a measure of nutritional status
Time frame: Six months
Population: No data collected.
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).
Time frame: Six months
Population: No data collected.
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).
Time frame: Six months
Population: No data were collected.
Weight Loss
Change in BMI will be used as a marker of nutritional status.
Time frame: Six months
Population: No data collected.