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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether hyperbaric oxygen therapy can support individuals with multiple myeloma, a type of blood cancer, who are set to undergo high-dose therapy and stem cell transplants. The goal is to determine if breathing pure oxygen in a pressurized room can improve outcomes during this intense treatment phase. Participants will receive hyperbaric oxygen treatment on specific days around their chemotherapy and transplant. This trial is suitable for individuals with multiple myeloma who are physically fit for high-dose treatment and have good heart, liver, and lung function. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to explore this innovative therapy.

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.

What prior data suggests that hyperbaric oxygen therapy is safe for multiple myeloma patients?

Research has shown that hyperbaric oxygen therapy (HBO) is generally safe for people with cancer. In studies involving patients with multiple myeloma, repeated HBO treatments were well tolerated, with no severe side effects that would halt the treatment. Reviews of various studies also confirm HBO's safety for cancer patients. Overall, evidence suggests that HBO is a well-tolerated treatment option, with no major safety concerns reported in past research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Hyperbaric oxygen therapy is unique because it involves breathing pure oxygen in a pressurized room or chamber, which isn't a typical approach for treating multiple myeloma. Most treatments for this condition, like chemotherapy and stem cell transplants, target cancer cells directly. However, hyperbaric oxygen therapy may enhance the effectiveness of these treatments by improving oxygen delivery to tissues, potentially aiding recovery and boosting the body's response to other therapies. Researchers are excited about this method because it could offer a new way to support and enhance the efficacy of existing treatments, providing a fresh approach to managing multiple myeloma.

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

Research has shown that hyperbaric oxygen (HBO) therapy might benefit people with multiple myeloma, a type of blood cancer. In this trial, participants will undergo repeated HBO treatments on Days 0, +1, and +2 of high-dose therapy with melphalan and autologous transplants. One study found that multiple HBO treatments were safe and did not cause major side effects for patients receiving high-dose therapy and stem cell transplants. Some evidence suggests that HBO can aid in blood count recovery, which is crucial after intense treatments. While HBO has shown promise in controlling tumors in other types of cancer, its effects on multiple myeloma remain under investigation. Early results are encouraging, but further research is needed to confirm its benefits for this specific condition. ^{2 3 4 5 6}

Who Is on the Research Team?

Omar Aljitawi, MMBS

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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 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 (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]

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 (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/144/Supplement%201/4741/533684/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 ...

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. 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.

4. 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.

5. 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 ...

6. 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.