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PI terminated study due to lack of enrollment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Ambient white light | Active Comparator | This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue light | Device | Participants undergoing this intervention will be exposed to blue (442nm) light. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Complete Response | Rate of complete response to neoadjuvant chemoradiation upon restaging | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain Control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Neal, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
Individual participant data after de-identification will be shared. A data dictionary will also be made available. Data will be available beginning 12 months and ending 36 months following article publication. Data will be shared with those researchers who provide a methodologically sound proposal. Only those data necessary to achieve the aims in the approved proposal will be shared. Proposals should be directed to the corresponding author and will undergo approval by the investigative team. To gain access after proposal approval, data requestors will need to sign a data access agreement. Data will be available for 1 year after proposal approval.
Data will be available beginning 12 months and ending 36 months following article publication.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Study terminated due to slow recruitment. Participants enrolled only to the Blue Light Arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Complete Response | Rate of complete response to neoadjuvant chemoradiation upon restaging | Trial was terminated before the outcome measure data were collected. | Posted | Six months |
|
Up to 15 days
Study terminated due to slow recruitment. Participants enrolled only to the Blue Light Arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Neal | University of Pittsburgh | 412-647-1158 | nealm2@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2022 | Mar 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Randomization will achieved with block randomization on the following characteristics:
b. Age (<55 years, >/= 55 years)
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| Amber light | Device | Participants undergoing this intervention will be exposed to amber (617nm) light. |
|
| Ambient White Light | Other | This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments |
|
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 |
| 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 |
| Functional Status | The Karnofsky Performance Scale - Lowest score 0% (dead), Highest score 100% (normal; no complaints, no evidence of disease) | Six months |
| Weight Loss | Change in BMI will be used as a marker of nutritional status. | Six months |
| Circadian Activation | Rev-erb alpha concentration | Six months |
| Immune Modulation | Cytokine levels (IL-10,IL-6) | Six months |
| Chemoradiation Tolerance | Percentage of planned chemoradiation completed | Six months |
| Prealbumin Level | Change in prealbumin level will be used as a measure of nutritional status | Six months |
| BG001 | 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. |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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 |
|
| 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). | No data were collected. | Posted | 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). | No data collected. | Posted | 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). | No data collected. | Posted | Six months |
|
|
| Secondary | Functional Status | The Karnofsky Performance Scale - Lowest score 0% (dead), Highest score 100% (normal; no complaints, no evidence of disease) | No data collected. | Posted | Six months |
|
|
| Secondary | Weight Loss | Change in BMI will be used as a marker of nutritional status. | No data collected. | Posted | Six months |
|
|
| Secondary | Circadian Activation | Rev-erb alpha concentration | No data collected. | Posted | Six months |
|
|
| Secondary | Immune Modulation | Cytokine levels (IL-10,IL-6) | No data collected. | Posted | Six months |
|
|
| Secondary | Chemoradiation Tolerance | Percentage of planned chemoradiation completed | No data collected. | Posted | Six months |
|
|
| Secondary | Prealbumin Level | Change in prealbumin level will be used as a measure of nutritional status | No data collected. | Posted | Six months |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 0 | 0 | 0 | 0 | 0 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |