SPOT-ON for Shortness of Breath in Cancer Patients

Overseen By David Hui, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Hemodynamic instability, Delirium, Severe hypoxemia, 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: Unknown

Duration: 72 hours

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

To learn about the effect of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) treatment on the severity of shortness of breath in patients with cancer.

Will I have to stop taking my current medications?

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

Is the SPOT-ON treatment generally safe for humans?

Oxygen therapy, which is part of the SPOT-ON treatment, is generally safe but can increase carbon dioxide levels in the blood in some respiratory conditions. Long-term oxygen therapy has been used safely in conditions like chronic obstructive pulmonary disease (COPD), but it should be carefully managed to avoid potential harm. ^{1 2 3 4 5}

How is the SPOT-ON treatment for shortness of breath in cancer patients different from other treatments?

The SPOT-ON treatment is unique because it combines personalized oxygen therapy with supportive therapies specifically structured for cancer patients experiencing shortness of breath, unlike standard oxygen therapy which may not be effective for mildly- or non-hypoxaemic cancer patients. ^{5 6 7 8 9}

What data supports the effectiveness of the SPOT-ON treatment for shortness of breath in cancer patients?

Research shows that non-drug approaches like breathing retraining and psychosocial support can help cancer patients manage shortness of breath and anxiety. However, using oxygen alone hasn't shown clear benefits for cancer patients with mild breathing issues. ^{4 5 6 7 9}

Who Is on the Research Team?

David Hui

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for cancer patients experiencing shortness of breath. Specific eligibility details are not provided, but typically participants must meet certain health conditions to join.

Inclusion Criteria

My cancer is advanced and has spread or cannot be cured.

I experience significant shortness of breath even when resting.

I am currently admitted to a hospital ward.

Exclusion Criteria

Severe hypoxemia (SpO2 < 90% despite supplemental oxygen of up to 6 L/min)

Patients with known pregnancy

I need a machine to help me breathe and will undergo a procedure to remove fluid from my chest soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SPOT-ON and Enhanced Usual Care to manage dyspnea, with education and standard treatments provided by the healthcare team

72 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and quality of life assessments

1 year

What Are the Treatments Tested in This Trial?

Interventions

• SPOT-ON Delayed Start
• SPOT-ON Early Start

Trial Overview The study tests the SPOT-ON treatment's impact on easing shortness of breath in cancer patients. It compares two groups: one starts treatment early (Early Start), and the other later (Delayed Start).

How Is the Trial Designed?

Group I: Group 2: SPOT-ON Waitlist Experimental Treatment 2 Interventions

Participants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team.

Group II: Group 1: SPOT-ON Experimental Treatment 2 Interventions

Participants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a meta-analysis of 134 cancer patients, palliative oxygen therapy did not significantly improve dyspnoea symptoms in patients who were not hypoxaemic, indicating limited efficacy for this treatment in such cases.

The study suggests that despite the common use of oxygen therapy for symptom relief, it may not provide benefits for cancer patients with refractory dyspnoea who do not qualify for home oxygen therapy, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen for relief of dyspnoea in mildly- or non-hypoxaemic patients with cancer: a systematic review and meta-analysis. Uronis, HE., Currow, DC., McCrory, DC., et al.[2022]

A tailored non-pharmacological intervention combining breathing retraining and psychosocial support significantly improved average dyspnea and perceived control over dyspnea in 144 cancer patients over an 8-week period compared to standard care.

The intervention also led to a notable reduction in anxiety levels among participants, highlighting its potential benefits for managing emotional distress related to dyspnea, although it did not affect worst dyspnea or other measures like functional status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Non-pharmacological Intervention for Cancer-Related Dyspnea. Yates, P., Hardy, J., Clavarino, A., et al.[2020]

Long-term oxygen therapy (LTOT) has been proven to prolong life in patients with chronic obstructive pulmonary disease (COPD) and severe daytime hypoxemia, based on landmark trials involving 290 patients over 35 years ago.

Despite the expansion of oxygen therapy indications, most randomized controlled trials have not shown significant benefits outside of LTOT for severely hypoxemic COPD patients, highlighting the need for further research on the mechanisms, adherence, and cost-effectiveness of oxygen therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Oxygen in Chronic Obstructive Pulmonary Disease. Lacasse, Y., Tan, AM., Maltais, F., et al.[2019]

A double-blind, randomized controlled trial involving cancer patients demonstrated that dexamethasone significantly reduces dyspnoea, or difficulty breathing, indicating its efficacy in managing this distressing symptom.

The study's design and rigorous methodology provide strong evidence for the use of dexamethasone as a therapeutic option for alleviating dyspnoea in patients with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In cancer with dyspnea, high-dose dexamethasone did not improve dyspnea and increased SAEs. Certo, M., Arnold, R.[2023]

Supplemental oxygen is not routinely recommended for patients with dyspnea and terminal cancer due to potential negative effects, including psychological dependence and impaired quality of life.

Symptomatic treatments like morphine and physical care methods, such as massage, are emphasized as essential alternatives when specific treatments are no longer viable, and any use of supplemental oxygen should be closely monitored for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Supplemental oxygen for dyspnea for cancer patients in end-of-life palliative care]. Béziaud, N., Diab, S., Laval, G.[2016]

High concentration oxygen therapy can increase carbon dioxide levels (PaCO2) not only in COPD but also in other respiratory disorders like asthma and pneumonia, as well as chronic conditions like obesity hypoventilation syndrome.

Consensus guidelines recommend careful titration of oxygen therapy in these conditions to maximize benefits while minimizing the risks associated with excessive oxygen (hyperoxia).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of high concentration oxygen therapy on PaCO2 in acute and chronic respiratory disorders. Pilcher, J., Perrin, K., Beasley, R.[2020]

This study is a large-scale, multicenter trial involving 2126 patients to compare the effects of long-term oxygen therapy (LTOT) for 24 hours a day versus 15 hours a day on all-cause mortality in patients with chronic respiratory conditions, including COPD.

The trial aims to provide comprehensive data on the benefits and potential harms of continuous LTOT, with a primary focus on survival rates after one year, while also assessing quality of life and hospitalization rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol. Sundh, J., Bornefalk-Hermansson, A., Ahmadi, Z., et al.[2020]

Long-term oxygen therapy using portable liquid oxygen systems may help improve functional abilities in patients with severe COPD who experience borderline or exertional hypoxemia, even if they don't meet standard criteria for oxygen therapy.

The proposed study will use a multicentric, randomized design to assess the effectiveness of oxygen therapy through various functional tests, aiming to provide evidence for its benefits in enhancing walking distance and overall health in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of long-term oxygen therapy due to portable liquid oxygen tanks in disabled malnourished chronic obstructive pulmonary disease patients with borderline hypoxemia. Aim of the study and methods. Mitlehner, W.[2018]

A qualitative study involving nine patients with lung cancer or pleural mesothelioma revealed that non-pharmacological breathlessness management programs significantly improve patients' functional capacity and coping strategies.

The benefits of the program are attributed to a combination of effective breathing techniques, activity management, and the supportive qualities of the therapists, highlighting the importance of personalized care in managing dyspnoea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual experiences and impacts of a physiotherapist-led, non-pharmacological breathlessness programme for patients with intrathoracic malignancy: a qualitative study. Wood, H., Connors, S., Dogan, S., et al.[2015]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Oxygen for relief of dyspnoea in mildly- or non-hypoxaemic patients with cancer: a systematic review and meta-analysis. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Non-pharmacological Intervention for Cancer-Related Dyspnea. [2020]

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

Home Oxygen in Chronic Obstructive Pulmonary Disease. [2019]

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

In cancer with dyspnea, high-dose dexamethasone did not improve dyspnea and increased SAEs. [2023]

5. France pubmed.ncbi.nlm.nih.gov

[Supplemental oxygen for dyspnea for cancer patients in end-of-life palliative care]. [2016]

6. Germany pubmed.ncbi.nlm.nih.gov

The effect of high concentration oxygen therapy on PaCO2 in acute and chronic respiratory disorders. [2020]

7. England pubmed.ncbi.nlm.nih.gov

REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of long-term oxygen therapy due to portable liquid oxygen tanks in disabled malnourished chronic obstructive pulmonary disease patients with borderline hypoxemia. Aim of the study and methods. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Individual experiences and impacts of a physiotherapist-led, non-pharmacological breathlessness programme for patients with intrathoracic malignancy: a qualitative study. [2015]