Clinical trial · Interventional
Thermal Therapy for the Treatment of Depression in Cancer Survivors, the S-WARM Study
Survivor Warming to Alter Mood (S-WARM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Awaiting grant funding for next phase of study
Summary
Brief summary (as posted)
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 capacity, fatigue, and enhance positive mood and sleep quality. The purpose of this study is to evaluate the potential of thermal therapy to improve patient's quality of life by reducing symptoms of depression, sleep disruption, fatigue and anxiety in cancer survivors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Thermotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment of depression (thermal therapy)
- description
- Patients undergo thermal therapy over 2.5 hours.
- interventionNames
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Procedure: Thermotherapy
Primary outcomes (1)
- measure
- Change in depression
- timeFrame
- Baseline to 1 or 2 weeks after completion of therapy
- description
- Measured by the Hamilton Depression Rating Scale.
Secondary outcomes (2)
- measure
- Durability of and variability in the response over time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available