Clinical trial NCT04803630: Thermal Therapy for the Treatment of Depression in Cancer Survivors, the S-WARM Study
Official title: Survivor Warming to Alter Mood (S-WARM)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in depression
timeFrame: Baseline to 1 or 2 weeks after completion of therapy
Secondary outcomes:
measure: Durability of and variability in the response over time
timeFrame: Up to 4 months after completion of therapy
measure: Change in Pittsburgh Sleep Quality Index scores
timeFrame: Baseline, up to 4 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Anurag K Singh
role: PRINCIPAL_INVESTIGATOR
References: