NCT04803630

Thermal Therapy for the Treatment of Depression in Cancer Survivors, the S-WARM Study

Survivor Warming to Alter Mood (S-WARM)

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 potential of thermal therapy to improve quality of life by reducing symptoms of sleep disruption in cancer survivors. EXPLORATORY OBJECTIVE: I. To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of fatigue, anxiety and other generally debilitating aspects of increased stress in cancer survivors. OUTLINE: Patients undergo thermal therapy over 2.5 hours. After completion of study treatment, patients are followed up at weeks 1 or 2, 3 or 4, and then monthly for months 2-4.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Thermotherapy	Undergo thermal therapy

Timeline

• Start date: 2021-05-06
• Primary completion: 2026-05-06
• Completion: 2027-05-06
• First posted: 2021-03-18
• Last updated: 2022-05-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study