Aromatherapy for Cancer Distress

Recruiting at 2 trial locations

Overseen By Aubrey Florom-Smith, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: CART infusion, Germ cell tumor, ICANS, Scleroderma, Atrial fibrillation, others

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

Compensation: Varies

Number of Visits: 3

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an aromatherapy inhaler can reduce stress and improve coping for patients undergoing a specific type of stem cell transplant. The inhaler contains essential oils, such as lavender and peppermint, known for their calming effects. Participants will either use the inhaler alongside their regular care or receive standard care first and then try the inhaler. Patients with blood cancers who have undergone chemotherapy and are not allergic to these essential oils might be suitable candidates. As an unphased trial, this study offers patients the opportunity to explore innovative stress-reduction methods during their treatment journey.

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

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

What prior data suggests that aromatherapy inhalers are safe for cancer patients?

Research has shown that aromatherapy inhalers are generally safe for cancer patients. Studies have found that aromatherapy can help reduce anxiety in these patients. In a clinical setting, essential oils used in aromatherapy must be clearly labeled, and safety information must be available to ensure safe use. This ensures careful handling of the oils to minimize any risks.

While strong evidence supports aromatherapy's effectiveness for anxiety, it may not address other issues like depression or overall mental well-being. Overall, aromatherapy is considered safe and is usually well-tolerated, with few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the aromatherapy inhaler for cancer distress because it offers a non-pharmacological way to manage stress and emotional discomfort. Unlike standard treatments that rely on medications, this inhaler uses natural essential oils, allowing for a potentially calming effect without the side effects associated with drugs. The inhaler can be used as needed, offering flexibility and immediate relief throughout the day. Additionally, it taps into the power of scent to directly influence mood and well-being, which is a novel approach compared to traditional methods.

What evidence suggests that aromatherapy inhalers might be effective for cancer distress?

Research has shown that aromatherapy can help reduce anxiety in cancer patients. Previous studies found that aromatherapy inhalers noticeably calmed anxiety. Essential oils, such as lavender, have been shown to lower stress and anxiety levels. However, the effects on depression and overall mental well-being remain less clear. About 70% of studies reported a positive impact on stress and anxiety after using aromatherapy. In this trial, participants will experience different sequences of aromatherapy inhaler use and standard care to evaluate its impact. While results can vary, many patients find some relief from their anxiety and stress through aromatherapy. ^{1 2 3 6 7}

Who Is on the Research Team?

Anna Oh, PhD, MPH, RN

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adult cancer patients who are undergoing bone marrow transplant (HSCT) and have experienced cancer-related distress. Participants must be over 18, speak English, and able to consent. They should not have allergies to lavender or peppermint oils, a history of certain conditions like scleroderma or atrial fibrillation, nor be receiving treatment for germ cell tumors.

Inclusion Criteria

I am scheduled for a stem cell transplant at E1.

I have received chemotherapy as part of my treatment preparation.

I need a stem cell transplant for my blood cancer.

Exclusion Criteria

I am admitted for a specific immune cell therapy.

Unexpected/unplanned admission (e.g., neutropenic fever, confusion, clinical deterioration)

I have a history of scleroderma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Phase 1

Participants use the aromatherapy inhaler as needed for up to two hours in the morning and complete the Aromatherapy Inhaler Use Log. Study personnel administer the NCCN Distress Thermometer and Problem List.

1 day

1 visit (in-person)

Phase 2

Participants receive standard of care pharmacological intervention only.

1 day

1 visit (in-person)

Phase 3

Participants use the aromatherapy inhaler as needed and complete the Aromatherapy Inhaler Use Log. Study personnel administer the NCCN Distress Thermometer and Problem List.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Aromatherapy Inhaler

Trial Overview The study is testing whether using an aromatherapy inhaler with essential oils can help reduce distress and improve coping in patients right after they've had a hematopoietic stem cell transplant.

How Is the Trial Designed?

Group I: SOC only then SOC plus Aromatherapy Inhaler Experimental Treatment 1 Intervention

1. Participant will receive standard of care pharmacological intervention (SOC) as needed throughout the day. 2. Participants will complete the Standard of Care Pharmacological Intervention Use Log. 3. At between 1300 and 1500 hours, study personnel will administer the NCCN Distress Thermometer and Problem List.

Group II: SOC and Aromatherapy Inhaler then SOC only Experimental Treatment 1 Intervention

1. Participant will use the aromatherapy inhaler as needed for up to two (2) hours in the morning and complete the Aromatherapy Inhaler Use Log. 2. At between 1300 and 1500 hours, study personnel will administer the NCCN Distress Thermometer and Problem List.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Stanford Nurse Alumnae, Stanford University

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study involving 288 cancer patients, aromatherapy massage showed a significant short-term benefit in reducing anxiety and depression at 6 weeks post-treatment, but not at 10 weeks, indicating its effects may diminish over time.

While patients reported greater self-improvement in anxiety after receiving aromatherapy massage, the long-term efficacy compared to usual supportive care was not significant, suggesting that while it may help temporarily, it may not be a lasting solution for managing anxiety and depression in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of aromatherapy massage in the management of anxiety and depression in patients with cancer: a multicenter randomized controlled trial. Wilkinson, SM., Love, SB., Westcombe, AM., et al.[2022]

Aromatherapy massage significantly reduced anxiety levels in breast cancer patients, as evidenced by improvements in the State-Trait Anxiety Inventory and Hospital Anxiety and Depression Scale tests during and after treatment.

The study also indicated that aromatherapy massage may enhance the immunologic state of patients, suggesting potential benefits beyond psychological effects, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiolytic effect of aromatherapy massage in patients with breast cancer. Imanishi, J., Kuriyama, H., Shigemori, I., et al.[2020]

Aromatherapy massage significantly reduced anxiety and depression in cancer patients, with HADS scores improving from 8.9 to 6.2 for anxiety and from 6.1 to 4.0 for depression after six sessions, based on a study of 58 patients.

Over 50% of patients reported significant improvements in common symptoms, indicating that aromatherapy can play a beneficial role in managing psychological distress during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an aromatherapy service at a Cancer Centre. Kite, SM., Maher, EJ., Anderson, K., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9215260/

The Effects of Aromatherapy on Anxiety and Depression in ... In cancer patients, the aromatherapy was effective for relieving anxiety. However, there was no beneficial effect on depression and psychological wellbeing.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876382023000999

Effects of aromatherapy on anxiety in patients with cancer A previous meta-analysis found that aromatherapy is effective in reducing anxiety in patients with cancer; however, it only confirmed the effects of inhalation ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12180096/

The Effect of Aromatherapy on Pain and Anxiety Levels Before ... In women with breast cancer, essential oils, including lavender, have been associated with reduced anxiety, stress (10, 11), pain (12), and ...

4. cancer.gov cancer.gov/about-cancer/treatment/cam/patient/aromatherapy-pdq

Aromatherapy With Essential Oils (PDQ®)–Patient Version Studies of aromatherapy have shown mixed results. There have been some reports of improved mood, anxiety, sleep, nausea, and pain. Other studies ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1744388123000312

Benefit of inhalation aromatherapy as a complementary ... 70% of studies reported a positive effect on stress and anxiety post intervention. •. High variability in mode of application and dosage of essential oil. •.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04826601

The Physical and Psychologic Effects of Aromatherapy in ... Purpose: The aims of this study are to evaluate the effects of aromatherapy on cancer patient receiving chemotherapy: 1) for physical effects by meridian ...

7. accc-cancer.org accc-cancer.org/docs/documents/oncology-issues/articles/2018/so18/so18-safe-essential-oil-practice-in-cancer-centers.pdf?sfvrsn=ded0f0e2_9

Safe Essential Oil Practice in Cancer Centers In the clinical setting, all essential oils should be labeled and safety data sheets should be available. A safety data sheet provides detailed information ...