Hyperbaric Oxygen Therapy for Multiple Myeloma

No longer recruiting at 2 trial locations

Overseen By Erin Cebula, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Omar Aljitawi

Disqualifiers: Pregnant, COPD, Pneumothorax, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Varies

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether hyperbaric oxygen therapy (breathing pure oxygen in a special chamber) can help people with multiple myeloma recover blood counts faster after a stem cell transplant. Participants will be divided into two groups: one will receive the oxygen therapy before the transplant, and the other will not. The researchers aim to determine if the oxygen therapy speeds up recovery. Individuals diagnosed with multiple myeloma and planning to undergo a stem cell transplant might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hyperbaric oxygen therapy (HBO) is generally safe for people with cancer. Studies have found that patients with multiple myeloma tolerate HBO well, without serious side effects. Specifically, one study found that repeated HBO treatments did not cause harmful effects in these patients. Another review confirmed HBO's safety for individuals with various types of cancer. Overall, this evidence suggests that HBO therapy is a safe option for patients undergoing treatments such as stem cell transplants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Researchers are excited about hyperbaric oxygen therapy for multiple myeloma because it offers a unique approach that could enhance the effectiveness of existing treatments. Unlike standard options like chemotherapy, radiation, or stem cell transplants alone, hyperbaric oxygen therapy involves breathing pure oxygen in a pressurized environment. This method may improve the oxygen supply to tissues, potentially boosting the success rate of hematopoietic stem cell infusions by creating a more favorable environment for cell growth and recovery. This innovative approach could lead to better outcomes and quicker recovery times for patients.

What evidence suggests that hyperbaric oxygen therapy might be an effective treatment for multiple myeloma?

This trial will compare Hyperbaric Oxygen Therapy (HBO) with no HBO in patients undergoing hematopoietic stem cell infusion for multiple myeloma. Research has shown that HBO might assist in treating multiple myeloma, particularly during stem cell transplants. Studies have found that HBO can accelerate the recovery of crucial blood cells, like CD-4 and CD-8, which support the immune system. Patients have tolerated this therapy well without serious side effects. Additionally, evidence suggests that HBO might help control tumors in some cancers. Overall, these findings indicate that HBO could be effective in aiding recovery during treatments for multiple myeloma. ^{1 3 6 7 8}

Who Is on the Research Team?

Omar Aljitawi, MD

Principal Investigator

Wilmot Cancer Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am being considered for a high-dose therapy and stem cell transplant at Wilmot Cancer Institute.

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.

Exclusion 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.

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants receive one hyperbaric oxygen therapy session approximately six hours prior to hematopoietic stem cell infusion

1 day

1 visit (in-person)

Treatment

Participants undergo high-dose therapy and autologous hematopoietic stem cell transplantation

Varies

Follow-up

Participants are monitored for blood count recovery and progression-free survival

100 days for neutrophil count recovery, up to 1 year for progression-free survival

What Are the Treatments Tested in This Trial?

Interventions

• Hyperbaric Oxygen Therapy
• No Hyperbaric Oxygen Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Hyperbaric Oxygen Therapy Experimental Treatment 1 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 Therapy Active Control 1 Intervention

Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.

Who Is Running the Clinical Trial?

Omar Aljitawi

Lead Sponsor

Trials

2

Recruited

120+

Published Research Related to This Trial

In a study of 23 oncological patients undergoing hyperbaric oxygen therapy (HBOT) for radiotherapy complications, it was found that HBOT may reduce bone remodeling activity, as indicated by a 6% decrease in the serum levels of the bone formation marker P1NP after treatment.

Patients with neoplasms exhibited higher baseline bone turnover compared to those with chronic anal fissures, suggesting that HBOT could be beneficial in managing increased bone remodeling in cancer patients post-radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of hyperbaric oxygen therapy on bone metabolism in patients with neoplasm. Salmón-González, Z., Anchuelo, J., Borregán, JC., et al.[2022]

Hyperbaric oxygen therapy, which involves breathing 100% oxygen under high pressure, significantly increases the amount of oxygen available for cellular metabolism, leading to various beneficial effects that support healing in conditions like clostridial myonecrosis and chronic wounds.

While hyperbaric oxygen is now recognized as an effective adjunctive treatment for several medical conditions, further randomized controlled trials are needed to fully establish its efficacy and optimize its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy in trauma surgery]. Mutschler, W., Muth, CM.[2019]

Hyperbaric oxygen therapy (HBO) showed a significant reduction in pain intensity for pediatric oncology patients with bone marrow edema (BME) and aseptic osteonecrosis (AON), particularly in younger girls, where pain scores decreased from an average of 2.4 to 0 during treatment.

While HBO therapy appeared to help reduce AON lesions in younger girls, it did not demonstrate a beneficial effect on BME in older children, indicating that the effectiveness of HBO may vary by age and type of lesion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow oedema and aseptic osteonecrosis in children and adolescents with acute lymphoblastic leukaemia or non-Hodgkin-lymphoma treated with hyperbaric-oxygen-therapy (HBO): an approach to cure? -- BME/AON and hyperbaric oxygen therapy as a treatment modality. Bernbeck, B., Christaras, A., Krauth, K., et al.[2019]

Citations

1. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/7068/505921/A-Pilot-Study-to-Determine-the-Safety-and-Efficacy

A Pilot Study to Determine the Safety and Efficacy of Repeated ... Multiple HBO treatment were well tolerated without treatment limiting toxicity during autologous HSCT for multiple myeloma.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3510426/

Hyperbaric oxygen therapy and cancer—a review They concluded that there is some evidence that HBO improves local tumor control and mortality in tumors of the head and neck; however, the outcomes seem to be ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124074998

Hyperbaric Oxygen (HBO) Effects on Blood Count ... HBO resulted in lower EPO levels at Day +1 of auto-HSPC, translating to faster ALC recovery, improved CD-4 and CD-8 cell subset recovery, and improved 1-year ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04862676

Repeated HBO Therapy in Myeloma Patients Undergoing ... Possible long-term effects of hyperbaric oxygen therapy treatment prior to autologous peripheral blood stem cell transplant will be assessed at day +100 post- ...

5. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/2221/498879/Hyperbaric-Oxygen-HBO-Effects-on-Blood-Count

Hyperbaric Oxygen (HBO) Effects on Blood Count Recovery ... A Pilot Study to Determine the Safety and Efficacy of Repeated Hyperbaric Oxygen Therapy in Multiple Myeloma Patients Undergoing High-Dose ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0006497123136640

A Pilot Study to Determine the Safety and Efficacy of ... Multiple HBO treatment were well tolerated without treatment limiting toxicity during autologous HSCT for multiple myeloma.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03398200

NCT03398200 | Effects of Hyperbaric Oxygen (HBO) on ... Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.

8. clinicaltrial.be clinicaltrial.be/en/details/44617?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Repeated HBO Therapy in Myeloma Patients Undergoing ... Possible long-term effects of hyperbaric oxygen therapy treatment prior to autologous peripheral blood stem cell transplant will be assessed at ...