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

NCT ID: NCT04803630

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2027-05-06

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment of depression (thermal therapy)

Patients undergo thermal therapy over 2.5 hours.

Group Type: EXPERIMENTAL

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Thermotherapy

Intervention Type: PROCEDURE

Undergo thermal therapy

Interventions

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Thermotherapy

Undergo thermal therapy

Intervention Type: PROCEDURE

Other Intervention Names

Quality of Life Assessment; Heat Therapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anurag K Singh

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

NCI-2021-01102

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 79318

Identifier Type: OTHER

Identifier Source: secondary_id

I 79318

Identifier Type: -

Identifier Source: org_study_id