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

Malignant Solid Neoplasm Clinical Trial

Official title:

Survivor Warming to Alter Mood (S-WARM)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04803630
• Other study ID #: I 79318
• Secondary ID: NCI-2021-01102I
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: May 6, 2021
• Est. completion date: May 6, 2027

Study information

• Verified date: May 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 6, 2027
• Est. primary completion date: May 6, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Thermotherapy
Undergo thermal therapy

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression	Measured by the Hamilton Depression Rating Scale.	Baseline to 1 or 2 weeks after completion of therapy
Secondary	Durability of and variability in the response over time	Hypothesis tests of mixed effect model fixed effect slope parameters representing the population averaged changes in HDRS over time will be used to investigate whether the thermal intervention effects are durable over the course of the study.	Up to 4 months after completion of therapy
Secondary	Change in Pittsburgh Sleep Quality Index scores	A 19 self-rated questionnaire. Each item is weighted on a 0-3 interval scale where lower scores denote a healthier sleep quality.	Baseline, up to 4 months