What side effects are associated with this type of intervention?

Common treatments for stem cell transplant, particularly myeloablative conditioning regimens, are associated with significant toxicity, including hematologic, gastrointestinal, hepatic, hemorrhagic, infectious, metabolic, and pulmonary complications, with treatment-related mortality rates of 30 to 50 percent. Reduced intensity and nonmyeloablative conditioning regimens have lower non-relapse mortality but still pose risks such as relapse and graft-versus-host disease (GVHD). Supportive care measures like high heated humidity aim to reduce mucositis by maintaining moisture in mucous membranes, thereby reducing inflammation and discomfort.

What prior FDA approvals exist?

FDA-approved treatments for stem cell transplants often focus on managing complications such as graft-versus-host disease (GVHD) and mucositis. Palifermin (Kepivance) is one such drug approved to reduce the incidence and duration of severe oral mucositis in patients undergoing high-dose chemotherapy and radiation therapy followed by stem cell rescue. Additionally, various supportive care measures, including hydration and pain management, are commonly employed to maintain mucous membrane moisture and reduce inflammation and discomfort. While specific FDA approvals for high heated humidity are not detailed, these treatments collectively aim to improve patient outcomes during stem cell transplants.

What other types of research exist?

Promising alternatives to High Heated Humidity for stem cell transplant patients include: 1) Active Heat and Moisture Exchanging Filters (aHMEF), which provide effective, controllable, and convenient humidification of inspired gases. 2) Omega-3 fatty acid supplementation, which has shown benefits in reducing inflammation and improving mucosal health. 3) Lifitegrast ophthalmic solution, which has demonstrated efficacy in reducing inflammation and discomfort in dry eye disease and may have potential applications in mucosal membrane care.

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High Heated Humidity for Stem Cell Transplant Patients

Phase 2

Waitlist Available

Led By Lisa Lem

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum 18 years of age

Performance status of ECOG 0-2

Must not have

Patients who have Obstructive Sleep Apnea who use a CPAP machine at night. This population would not be able to use the intervention concurrently with the CPAP device as both utilize the nares.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during treatment (up to 14 days)

Awards & highlights

Summary

This trial is testing a machine that provides warm, moist air to help heal mouth and throat sores in cancer patients undergoing intense treatments. The goal is to reduce pain and speed up recovery for these patients.

Who is the study for?

Adults with non-Hodgkin lymphoma, Hodgkin lymphoma, or multiple myeloma who need high-dose chemotherapy and a stem cell transplant. They must be able to consent, follow the study plan, and have an ECOG performance status of 0-2. Not for those with sleep apnea using CPAP machines, nasal blockages, influenza-like illness or tracheostomy tubes.

What is being tested?

The trial is testing the effects of high heated humidity delivered through a device called Airvo on mucositis in patients undergoing stem cell transplants as part of their cancer treatment.

What are the potential side effects?

Potential side effects may include discomfort from the heat and humidity delivery system or irritation in the nose if there's sensitivity due to existing conditions like polyps or deviated septum.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old.

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I can take care of myself and perform daily activities.

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I have lymphoma or multiple myeloma and need a specific stem cell transplant.

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I have lymphoma or multiple myeloma and need a specific stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have Obstructive Sleep Apnea and use a CPAP machine at night.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the comparison will be weight at admission vs weight at discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the comparison will be weight at admission vs weight at discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and the comparison will be weight at admission vs weight at discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Patient weight

Mucositis severity assessment

Mucositis severity symptoms

Secondary study objectives

Febrile Neutropenia

Length of stay to be changed in hospital

Nosocomial infections

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention using the Airvo deviceExperimental Treatment1 Intervention

Patients randomized to this group will receive the standard of care as well as wear the Airvo (equipment to provide high heated humidity) starting on Day 0 of their transplant for a minimum of 4 hours a day (to be worn in one continuous block of time). The humidity is delivered by nasal cannula that goes into your nose, similar to wearing oxygen. The equipment stands on a pole and plugs into a power outlet. Patients may take off the equipment for short periods of time. Eg to go to the bathroom.

Group II: Standard of CareActive Control1 Intervention

Patients randomized into this group will receive the usual standard of care for mucositis. The standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stem cell transplant include conditioning regimens like myeloablative conditioning (MAC) and reduced-intensity conditioning (RIC), which work by eradicating malignant cells and suppressing the immune system to prevent graft rejection. Supportive care measures, such as high heated humidity, help maintain moisture in mucous membranes, reducing inflammation and discomfort. These treatments are vital for ensuring successful engraftment and minimizing complications, thereby improving patient outcomes and quality of life during the recovery process.