Hyperbaric Oxygen Therapy for Multiple Myeloma

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

99 Participants Needed

Trial Summary

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.

How does hyperbaric oxygen therapy differ from other treatments for multiple myeloma?

Hyperbaric oxygen therapy (HBOT) is unique because it involves breathing pure oxygen in a pressurized environment, which increases the amount of oxygen in the blood and can improve tissue oxygenation. This approach is different from standard treatments for multiple myeloma, which typically involve chemotherapy or targeted drugs, as HBOT may enhance the effectiveness of these treatments by improving oxygen delivery to tissues. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial involves patients with Multiple Myeloma who are receiving high-dose therapy and stem cell transplants. Some participants will breathe pure oxygen in a pressurized room before their transplant to see if it helps them recover faster. The study will compare blood recovery times between those who receive the oxygen treatment and those who do not.

Research Team

Omar Aljitawi, MD

Principal Investigator

Wilmot Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Germany 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. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy in trauma surgery]. [2019]

3. Poland pubmed.ncbi.nlm.nih.gov

Influence of hyperbaric oxygen therapy on bone metabolism in patients with neoplasm. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The mechanisms by which hyperbaric oxygen and carbogen improve tumour oxygenation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of hyperbaric oxygen as a chemosensitizer in the treatment of epithelial ovarian cancer in xenografts in mice. [2019]