Status:
WITHDRAWN
Thermal Therapy for the Treatment of Depression in Cancer Survivors, the S-WARM Study
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This early phase I trial evaluates the effect of thermal therapy on depression with or without sleep disturbance in cancer survivors. Thermal therapy may help improve quality of life, physical capacit...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of depression in cancer survivors. SECONDARY OBJECTIVE: I. To evaluate the potenti...
Eligibility Criteria
Inclusion
- Patients who have had therapy for malignancy
- Age \>= 18 years
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- Patient denies current pregnancy
- Patients who screen positive on the depression/anxiety domain will be given the Hamilton Depression Rating Scale. Those with a score of 16 or more on this scale will be eligible for intervention
Exclusion
- History of prior myocardial infarction. These patients may be allowed with clearance from a cardiologist
- History of any condition deemed by the principal investigator to be a contraindication to S-WARM therapy (e.g., skin reaction, dysregulation of thermoregulation, etc.)
- All patients with transdermal patches (e.g.; fentanyl, Lidoderm, scopolamine, etc.)
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive S-WARM
- Received an investigational agent within 30 days prior to enrollment
- Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients on dialysis
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04803630
Start Date
May 6 2021
End Date
May 6 2027
Last Update
May 12 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263