Hyperbaric Oxygen Therapy for Multiple Myeloma

Overseen By Omar Aljitawi

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Rochester

Disqualifiers: Pregnant, COPD, Pneumothorax, Seizures, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 days

15 Participants Needed

Trial Summary

What is the purpose of this trial?

Subjects with multiple myeloma (MM) who are considered eligible for high-dose therapy and autologous stem cell transplantation by the transplant team at WCI will be enrolled in the study.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.

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

Hyperbaric oxygen therapy (HBOT) is unique because it involves breathing 100% oxygen in a pressurized chamber, which increases oxygen levels in the body and can help improve tissue healing and reduce complications from other cancer treatments. Unlike traditional chemotherapy or radiation, HBOT is not a drug but a supportive therapy that may enhance the effectiveness of other treatments and improve quality of life. ^{1 2 3 4 5}

Research Team

Omar Aljitawi, MMBS

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for adults with multiple myeloma who are fit enough for high-dose therapy and autologous stem cell transplantation. They must have good organ function and be able to perform daily activities without significant assistance. Pregnant or breastfeeding individuals, those with severe lung conditions, recent chest surgery or radiation, active infections, tobacco use before transplant, history of pneumothorax, ear/sinus issues or seizures cannot participate.

Inclusion Criteria

My liver, heart, and lungs are functioning well.

My heart condition allows me to perform daily activities with no or slight limitations.

I have been diagnosed with multiple myeloma.

Exclusion Criteria

I have had chest surgery or radiation to my lungs before.

You have used tobacco in the 3 days before the transplant.

I haven't had chemotherapy in the spine or brain radiation in the last 2 to 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hyperbaric oxygen therapy on Days 0, +1, and +2 of the transplant

3 days

3 visits (in-person)

Post-Transplant Monitoring

Participants are monitored daily until neutrophil recovery, then weekly through Day +100

100 days

Daily visits until neutrophil recovery, then weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Hyperbaric oxygen

Trial Overview The study is testing the effects of repeated Hyperbaric Oxygen (HBO) Therapy in patients with multiple myeloma undergoing high-dose chemotherapy followed by their own stem cell transplant. The goal is to see if HBO can improve outcomes during this intense treatment process.

Participant Groups

Group I: Experimental Arm:single Experimental Treatment 1 Intervention

Repeated treatments with hyperbaric oxygen on Days 0, +1 and +2 of high-dose therapy melphalan and autologous transplants.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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 oxygenation (HBO) has been shown to be a feasible and beneficial addition to polychemotherapy, enhancing treatment outcomes.

HBO procedures have demonstrated therapeutic effects in various postoperative conditions, including lymphorrhea after breast surgery, enteroparesis, wound infections, and posthemorrhagic anemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygenation--a method that improves the quality of life for cancer patients in the process of surgical and combined therapy]. Evtiukhin, AI., Shul'ga, NI., Dunaevskiĭ, IV.[2006]

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 (HBO) therapy involves breathing 100% oxygen at pressures greater than one atmosphere, which helps reduce gas-filled spaces and increases oxygen levels in tissues.

Research, including animal studies and clinical trials, has identified 12 specific medical conditions where HBO therapy may provide therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy. Fitzpatrick, DT.[2017]

Hyperbaric oxygen therapy (HBO2) is an approved treatment for severe anemia, and a systematic review of 35 publications shows that all studies report positive outcomes when using HBO2 for this condition.

The review emphasizes the importance of evidence-based medicine, with HBO2 being evaluated against rigorous standards, and suggests that it can be used alongside other treatments, although many alternatives lack robust clinical trial data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the application of hyperbaric oxygen in the treatment of severe anemia: an evidence-based approach. Van Meter, KW.[2018]

References

1. Poland pubmed.ncbi.nlm.nih.gov

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

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygenation--a method that improves the quality of life for cancer patients in the process of surgical and combined therapy]. [2006]

3. 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]

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

Hyperbaric oxygen therapy. [2017]

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

A systematic review of the application of hyperbaric oxygen in the treatment of severe anemia: an evidence-based approach. [2018]