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

NCT04803630 | Withdrawn Early Phase 1 FDA Drug

• 2 other identifiers: I 79318NCI-2021-01102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Change in depression

  Measured by the Hamilton Depression Rating Scale.

  Baseline to 1 or 2 weeks after completion of therapy

Secondary Outcomes (2)

• Durability of and variability in the response over time

  Up to 4 months after completion of therapy

• Change in Pittsburgh Sleep Quality Index scores

  Baseline, up to 4 months

Study Arms (1)

Treatment of depression (thermal therapy)

EXPERIMENTAL

Patients undergo thermal therapy over 2.5 hours.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Thermotherapy

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment of depression (thermal therapy)

Questionnaire Administration OTHER

Ancillary studies

Treatment of depression (thermal therapy)

Thermotherapy PROCEDURE

Undergo thermal therapy

Also known as: Heat Therapy

Treatment of depression (thermal therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Hyperthermia, Induced; Diathermy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Anurag K Singh

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 18, 2021
• Study Start: May 6, 2021
• Primary Completion: May 6, 2026
• Study Completion (Estimated): May 6, 2027
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

US (1)