Advanced or metastatic cancer Cancer Advanced or metastatic cancer
Conditions
Interventions
The study takes place over three study visits, separated by two to three weeks. All patients begin with a baseline observational period, and then participate in both blue-blocking eyeglasses and sham
Sponsors
Block Center for Integrative Cancer Treatment
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed, advanced or metastatic cancer (solid tumors other than brain, esophageal or pancreatic cancer) 2. Patients with more than one malignancy or with a prior malignancy are eligible to participate, if that other cancer is currently under control 3. Life expectancy of 6 months or more in the judgment of the treating physician 4. Patient must be scheduled to receive at least 3 cycles of chemotherapy, other systemic anti-cancer therapy, or ongoing active palliative care 5. Patient may start this study at any cycle in their treatment, and any reasonable cycle length is acceptable as long as measurements can be taken before each treatment 6. Any number of previous treatments with chemotherapy and/or other systemic targeted therapies are permitted 7. Prior or concurrent treatment on another clinical trial is not exclusionary for participation 8. ECOG Performance Status of 0, 1, or 2
Exclusion criteria
Exclusion criteria: 1. Active concomitant malignancy not currently under control 2. Women who are pregnant, breast-feeding or planning to become pregnant during the study 3. Less than 30 days from major surgery 4. Less than 30 days from radiation therapy 5. Uncontrolled/Symptomatic brain or CNS metastases 6. Symptomatic spinal cord compression 7. Uncontrolled psychiatric disorders that would prevent participation in the study in the judgment of the treating physician 8. Serious co-morbidity that would interfere with the patient’s capacity to participate in the study in the judgment of the treating physician 9. Blindness from any cause 10. Night shift workers 11. Melatonin supplementation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Circadian organization of sleep and activity rhythms as measured by actigraphy. The 24-hour autocorrelation of motion levels at each time of day for all intervention days will be the main actigraphic variable is measured using the actigraphy during the baseline, blue-blocker and sham glasses study periods. 2. Level of urinary 6-sulfatoxymelatonin in overnight urine sample at the end of the baseline, blue-blocker and sham glasses study periods | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Self-assessed nocturnal sleep using the Pittsburgh Sleep Quality Index (PSQI) and a sleep log at the end of the baseline, blue-blocker and sham glasses study periods 2. Cancer-associated self-assessed anxiety and depression using the Hospital Anxiety and Depression Scale at the end of the baseline, blue-blocker and sham glasses study periods 3. Self-assessed daytime fatigue as measured by Pittsburgh Sleep Quality Index at the end of the baseline, blue-blocker and sham glasses study periods 4. Self-assessed cancer-related quality of life using the EORTC and Powers and Ferrans Quality of Life scales at the end of the baseline, blue-blocker and sham glasses study periods 5. Self-assessed fatigue using the Piper Fatigue Scale at the end of the baseline, blue-blocker and sham glasses study periods | — |
Countries
United States of America
Contacts
Public ContactCharlotte Gyllenhaal
Outcome results
None listed