Pancreatic NeoplasmsNCT06164691
Blue and Amber Light Exposure in Patients With Rectal and Pancreatic Cancer
A study testing Blue light, Amber light and Ambient White Light in people with Pancreatic Neoplasms and Rectal Neoplasms, run by Matthew Neal MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Pancreatic Neoplasms, Rectal Neoplasms
- What is being tested?
- Blue light, Amber light and Ambient White Light
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2022to 29 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- greater than 18 and less than 80 years of age
- adenocarcinoma of the pancreas (unresectable) or adenocarcinoma of the rectum (stage II or III).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Effect of Peri-surgery Blue and Amber Light Exposure in Subjects Undergoing Medical and Surgical Treatment of Cancer
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.
Read the 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.
- Conditions
- Pancreatic Neoplasms, Rectal Neoplasms
- Being tested
- Blue light, Amber light, Ambient White Light
- Medical subject headings
- Pancreatic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue lightDevice
Participants undergoing this intervention will be exposed to blue (442nm) light.
Amber lightDevice
Participants undergoing this intervention will be exposed to amber (617nm) light.
Ambient White LightOther
This cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Other: Ambient White Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Complete Response
Rate of complete response to neoadjuvant chemoradiation upon restaging
Measured: Six months
Secondary outcomes (9)
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).
Measured: Six months
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).
Measured: 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).
Measured: Six months
Functional Status
The Karnofsky Performance Scale - Lowest score 0% (dead), Highest score 100% (normal; no complaints, no evidence of disease)
Measured: Six months
Weight Loss
Change in BMI will be used as a marker of nutritional status.
Measured: Six months
Circadian Activation
Rev-erb alpha concentration
Measured: Six months
Immune Modulation
Cytokine levels (IL-10,IL-6)
Measured: Six months
Chemoradiation Tolerance
Percentage of planned chemoradiation completed
Measured: Six months
Prealbumin Level
Change in prealbumin level will be used as a measure of nutritional status
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start14 Aug 2022
- Primary completion29 Apr 2023
- Study completion29 Apr 2023
Why it stopped: PI terminated study due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Neal MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Neal MD, University of Pittsburgh
- Investigators
- Matthew Neal, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164691
- Sponsor's protocol ID
- STUDY22060036
- Status last verified
- May 2024
- First submitted
- 1 Dec 2023
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peri-surgery Blue and Amber Light Exposure in Subjects Undergoing Medical and Surgical Treatment of Cancer
- ClinicalTrials.gov ID
- NCT06164691
- Acronym / sponsor ID
- STUDY22060036
- Conditions
- Pancreatic Neoplasms, Rectal Neoplasms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI terminated study due to lack of enrollment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Matthew Neal MDUniversity, hospital or other
- Study start
- 14 Aug 2022 (actual)
- Primary completion
- 29 Apr 2023 (actual)
- Study completion
- 29 Apr 2023 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Blue light | Experimental | Device: Blue lightThis 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 | Device: Amber lightThis 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 | Other: Ambient White LightThis cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- greater than 18 and less than 80 years of age
- adenocarcinoma of the pancreas (unresectable) or adenocarcinoma of the rectum (stage II or III).
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue lightParticipants undergoing this intervention will be exposed to blue (442nm) light. | Device | Blue light |
| Amber lightParticipants undergoing this intervention will be exposed to amber (617nm) light. | Device | Amber light |
| Ambient White LightThis cohort will be exposed to usual, ambient white lighting of the environment during chemotherapy and radiation treatments | Other | Ambient white light |
Primary outcome
Clinical Complete Response
Time frame: Six months
Rate of complete response to neoadjuvant chemoradiation upon restaging
9 secondary outcomes
Sleep Quality
Time frame: Six months
Pain Control
Time frame: Six months
Quality of Life as Determined by WHO QOL Survey.
Time frame: Six months
Functional Status
Time frame: Six months
Weight Loss
Time frame: Six months
Circadian Activation
Time frame: Six months
Immune Modulation
Time frame: Six months
Chemoradiation Tolerance
Time frame: Six months
Prealbumin Level
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Neal, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue light, Amber light and Ambient White Light in people with Pancreatic Neoplasms and Rectal Neoplasms, run by Matthew Neal MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Complete Response (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.