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

Early Phase 1

Withdrawn

• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Interventions: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Thermotherapy

• Registration Number: NCT04803630
• Lead Sponsor: Roswell Park Cancer Institute

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 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.

Study Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-18
• Study Start: 2021-05-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-12
• Primary Completion: 2026-05-06
• Study Completion: 2027-05-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment of depression (thermal therapy)	Questionnaire Administration	Patients undergo thermal therapy over 2.5 hours.
Treatment of depression (thermal therapy)	Quality-of-Life Assessment	Patients undergo thermal therapy over 2.5 hours.
Treatment of depression (thermal therapy)	Thermotherapy	Patients undergo thermal therapy over 2.5 hours.

Primary Outcome Measures

Name	Time	Method
Change in depression	Baseline to 1 or 2 weeks after completion of therapy	Measured by the Hamilton Depression Rating Scale.

Secondary Outcome Measures

Name	Time	Method
Change in Pittsburgh Sleep Quality Index scores	Baseline, up to 4 months	A 19 self-rated questionnaire. Each item is weighted on a 0-3 interval scale where lower scores denote a healthier sleep quality.
Durability of and variability in the response over time	Up to 4 months after completion of therapy	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.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States