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Hyperbaric Oxygen Therapy for Multiple Myeloma
Phase 2
Waitlist Available
Led By Omar Aljitawi, MD
Research Sponsored by Omar Aljitawi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days and 1 year
Awards & highlights
Study Summary
This trial will test whether hyperbaric oxygen therapy can speed up blood count recovery in patients with Multiple Myeloma who are receiving high-dose therapy and an autologous transplant.
Who is the study for?
This trial is for adults aged 18-75 with Multiple Myeloma who've had a partial response or better to initial therapy, or relapsed after stem cell transplant but were in remission for at least a year. They must have good heart, liver, and lung function and agree to use contraception if of childbearing potential. Excluded are those pregnant, breastfeeding, with severe lung disease requiring oxygen, ear/sinus infections, claustrophobia, seizures history.Check my eligibility
What is being tested?
The study tests whether one session of Hyperbaric Oxygen Therapy before autologous hematopoietic stem cell infusion can speed up blood count recovery compared to no such therapy. Participants at Wilmot Cancer Institute will be randomly assigned to either receive the therapy or not.See study design
What are the potential side effects?
Potential side effects from Hyperbaric Oxygen Therapy may include ear pressure changes leading to discomfort or pain, sinus problems, temporary vision changes and rarely more serious events like oxygen toxicity which could cause seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 100 days and 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days and 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time From Transplant to Neutrophil Count Recovery
Secondary outcome measures
Length of Hospital Stay
Number of Days of Granulocyte Colony-stimulating Factor
Number of Units of Packed Red Blood Cells Received
+3 moreSide effects data
From 2018 Phase 2 trial • 20 Patients • NCT0236395910%
Repeat bronchoscopy due to bleeding during biopsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hyperbaric Oxygen, Airway Biopsy
No Hyperbaric Oxygen, Airway Biopsy
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hyperbaric Oxygen TherapyExperimental Treatment1 Intervention
Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.
Group II: No Hyperbaric Oxygen TherapyActive Control1 Intervention
Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperbaric Oxygen Therapy
2016
Completed Phase 4
~720
Find a Location
Who is running the clinical trial?
Omar AljitawiLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Omar Aljitawi, MDPrincipal Investigator - Wilmot Cancer Institute
Strong Memorial Hospital
University Of Jordan (Medical School)
E Tn U-J H Quillen College Medicine (Residency)
6 Previous Clinical Trials
151 Total Patients Enrolled
3 Trials studying Multiple Myeloma
64 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy in the spine or brain radiation within the last month.You have a current infection of Hepatitis A, B, or C.I am being considered for a high-dose therapy and stem cell transplant at Wilmot Cancer Institute.I am between 18 and 75 years old.I am able to care for myself but may not be able to do active work.My liver, heart, and lungs are healthy enough for a transplant.My heart condition does not or only mildly limits my daily activities.I have had initial treatment for myeloma and responded well.Women who could become pregnant should have a negative pregnancy test within 4 weeks before starting the treatment.Your heart test (EKG) should not show any serious irregular heartbeats.My multiple myeloma returned after initial treatment or a stem cell transplant, but I was in remission for at least 12 months.I have a history of seizures.I have been diagnosed with multiple myeloma according to the latest standards.I do not have any active infections.My chest scans show signs of collapsed lung or significant lung scarring.I suffer from claustrophobia.I need oxygen therapy for my severe COPD.I have had a collapsed lung without injury.I currently have an ear or sinus infection.I have had chest surgery or radiation before.
Research Study Groups:
This trial has the following groups:- Group 1: Hyperbaric Oxygen Therapy
- Group 2: No Hyperbaric Oxygen Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any attendant risks associated with Hyperbaric Oxygen Therapy?
"While the efficacy of Hyperbaric Oxygen Therapy is yet to be fully understood, evidence suggests it has a level of safety that merits a 2 out of 3 ranking."
Answered by AI
Does this medical trial include individuals aged 30 or older as participants?
"For consideration in this medical trial, applicants must be between 18 and 75 years old. Furthermore, there are 42 clinical trials available for minors and 804 studies open to elderly patients."
Answered by AI
Is it feasible for me to register in this clinical experiment?
"This clinical trial requires 99 patients aged 18-75 years with a multiple myeloma diagnosis. Furthermore, the prospective participants must meet additional requirements such as having received appropriate induction therapy in response to their cancer, possessing an Alanine aminotransferase and Aspartate aminotransferase below 4x institutional upper limit of normal, total bilirubin less than 2 mg/dL; Ejection fraction higher than 45%, Forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide greater or equal to 50% of predicted value"
Answered by AI
Are there any vacancies available for individuals wishing to partake in this experiment?
"This medical trial is not presently enrolling patients, with its last edit taking place on August 10th 2022. Despite this fact, clinicaltrials.gov indicates that 818 other studies are currently seeking participants."
Answered by AI
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