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

Trial Summary

What is the purpose of this trial?

The purpose of this research is to evaluate aromatherapy inhaler use and how it may impact cancer distress and coping by patients in the first few days after hematopoietic stem cell transplant (HSCT).

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 data supports the effectiveness of the treatment Aromatherapy Inhaler for cancer distress?

Research shows that aromatherapy, including inhalation, can help reduce anxiety and depression in cancer patients. Studies found significant improvements in anxiety and depression scores after aromatherapy sessions, suggesting it can be a helpful complementary treatment for emotional distress in cancer patients. ^{1 2 3 4 5}

How does aromatherapy inhaler treatment differ from other treatments for cancer distress?

Aromatherapy inhaler treatment is unique because it uses essential oils to help alleviate distress in cancer patients, offering a non-invasive and natural alternative to traditional drug-based therapies. Unlike chemotherapy or other medical treatments, it focuses on improving emotional well-being through the sense of smell, which can be a comforting and soothing experience for patients. ^{6 7 8 9 10}

Research Team

Anna Oh, PhD, MPH, RN

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Effect of inhalation aromatherapy on physical and psychological problems in cancer patients: Systematic review and Meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Development of an aromatherapy service at a Cancer Centre. [2017]

3. United States 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. [2022]

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

Anxiolytic effect of aromatherapy massage in patients with breast cancer. [2020]

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

Aromatherapy with inhalation can effectively improve the anxiety and depression of cancer patients: A meta-analysis. [2022]

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

Phase II study of taxol in patients with untreated advanced non-small-cell lung cancer. [2019]

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

A randomized study of inpatient versus outpatient continuous intravenous infusion chemotherapy: psychosocial aspects. [2019]

8. Thailand pubmed.ncbi.nlm.nih.gov

Paclitaxel and carboplatin plus megestrol acetate in the treatment of advanced non-small cell lung cancer. [2015]

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

Use of a closed system drug-transfer device eliminates surface contamination with antineoplastic agents. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Single agent Taxol, 3-hour infusion, in untreated advanced non-small-cell lung cancer. [2020]