Hematopoietic and Lymphoid Cell NeoplasmEarly Phase 1NCT04803630
Thermal Therapy for the Treatment of Depression in Cancer Survivors, the S-WARM Study
A Early Phase 1 study testing Quality-of-Life Assessment, Questionnaire Administration and Thermotherapy in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Thermotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2021to 6 May 2027
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Survivor Warming to Alter Mood (S-WARM)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of depression in cancer survivors.
SECONDARY OBJECTIVE:
- To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of sleep disruption in cancer survivors.
EXPLORATORY OBJECTIVE:
- 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.
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Thermotherapy
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
ThermotherapyProcedure or surgery
Also called Heat Therapy
Undergo thermal therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment of depression (thermal therapy) | Experimental | Patients undergo thermal therapy over 2.5 hours. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Thermotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression
Measured by the Hamilton Depression Rating Scale.
Measured: Baseline to 1 or 2 weeks after completion of therapy
Secondary outcomes (2)
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.
Measured: Up to 4 months after completion of therapy
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.
Measured: Baseline, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start6 May 2021
- Primary completion6 May 2026 (estimated)
- Study completion6 May 2027 (estimated)
Why it stopped: Awaiting grant funding for next phase of study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anurag K Singh, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803630
- Sponsor's protocol ID
- I 79318
- Other IDs
- NCI-2021-01102, I 79318
- Status last verified
- May 2022
- First submitted
- 15 Mar 2021
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivor Warming to Alter Mood (S-WARM)
- ClinicalTrials.gov ID
- NCT04803630
- Acronym / sponsor ID
- I 79318
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Awaiting grant funding for next phase of study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 6 May 2026 (estimated)
- Study completion
- 6 May 2027 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of depression in cancer survivors.
SECONDARY OBJECTIVE:
- To evaluate the potential of thermal therapy to improve quality of life by reducing symptoms of sleep disruption in cancer survivors.
EXPLORATORY OBJECTIVE:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of depression (thermal therapy) | Experimental | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: ThermotherapyPatients undergo thermal therapy over 2.5 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment of depression (thermal therapy) |
| Questionnaire AdministrationAncillary studies | Other | Treatment of depression (thermal therapy) |
| ThermotherapyAlso: Heat TherapyUndergo thermal therapy | Procedure or surgery | Treatment of depression (thermal therapy) |
Primary outcome
Change in depression
Time frame: Baseline to 1 or 2 weeks after completion of therapy
Measured by the Hamilton Depression Rating Scale.
2 secondary outcomes
Durability of and variability in the response over time
Time frame: Up to 4 months after completion of therapy
Change in Pittsburgh Sleep Quality Index scores
Time frame: Baseline, up to 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anurag K Singh principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Quality-of-Life Assessment, Questionnaire Administration and Thermotherapy in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression (time frame: Baseline to 1 or 2 weeks after completion of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.