This phase III trial compares the effect of circadian effective light to circadian ineffective light for improving sleep and symptom burden in patients with multiple myeloma, lymphoma and leukemia that are undergoing an allogeneic or autologous stem cell transplant. Patients who undergo an allogeneic or autologous stem cell transplant can experience transplant-related complications that include sleep problems. These sleep problems can be worsened when the sleep-wake cycle is not aligned with the environment (circadian rhythm). Exposure to light is an important factor in circadian rhythms. Being exposed to circadian effective light may promote better nighttime sleep and improve quality of life.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05737732.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Sergio Andres Giralt
Icahn School of Medicine at Mount SinaiStatus: Active
Contact: Heiddis B. Valdimarsdottir
Phone: 917-453-7469
PRIMARY OBJECTIVES:
I. Confirm and extend our R21 results showing that the ambient lighting intervention promotes the alignment of sleep and nocturnal melatonin production.
II. Examine if circadian alignment reduces inflammation.
III. Determine whether better alignment and lower levels of pro-inflammatory markers are associated with fewer occurrences of neutropenic fever and reduced symptom burden.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo circadian effective light therapy and wear Actiwatch to assess sleep and activity and Daysimeter to monitor light exposure on study. Patients also undergo urine sample collection at baseline and 3 days after engraftment and undergo blood sample collection at baseline, 3 days after engraftment, and 4 weeks after engraftment on study.
ARM II: Patients undergo circadian ineffective light therapy and wear Actiwatch to assess sleep and activity and Daysimeter to monitor light exposure on study. Patients also undergo urine sample collection at baseline and 3 days after engraftment and undergo blood sample collection at baseline, 3 days after engraftment, and 4 weeks after engraftment on study.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationIcahn School of Medicine at Mount Sinai
Principal InvestigatorHeiddis B. Valdimarsdottir
