Evaluating the Feasibility and Acceptability of Inhalation Aromatherapy for Patients Undergoing Autologous Haematopoietic Stem Cell Transplant (HSCT)

Not Applicable

• Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)

• Registration Number: NCT07209501
• Lead Sponsor: Singapore General Hospital

Brief Summary

The goal of this clinical trial is to evaluate whether aromatherapy inhaler sticks can reduce nausea and vomiting in patients receiving chemotherapy as part of their stem cell transplant treatment. The main questions it aims to answer are:

* Can aromatherapy inhaler sticks be practically used by patients undergoing stem cell transplant (feasibility)?

* Do patients find aromatherapy inhaler sticks acceptable to use during their treatment?

* How effective are aromatherapy inhaler sticks at reducing chemotherapy-induced nausea and vomiting?

* What are patients' experiences when using aromatherapy during stem cell transplant?

Researchers will compare patients using aromatherapy inhaler sticks with essential oils to patients using inhaler sticks with only jojoba oil (placebo) to see if the essential oils provide additional benefits for reducing nausea and vomiting.

Participants will:

* Use their assigned inhaler stick every four hours when awake and whenever they feel nauseous

* Hold the inhaler stick a finger's length from their nostrils and inhale through one nostril at a time

* Use the inhaler stick for no more than 5 minutes per session

* Begin using the inhaler on the day of chemotherapy and continue until five days after chemotherapy completion (total of six days)

* Receive standard care for nausea and vomiting alongside the inhaler stick

* Complete study journals to record their experiences This is a single-blinded study, meaning participants will not know whether they received the aromatherapy or placebo inhaler stick.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-15
• Status Verified: 2025-10
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Primary Completion: 2026-06-23
• Study Completion: 2026-06-24

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1. At least 21 years and older 2. Able to provide informed consent 3. Admitted for autologous stem cell transplant receiving melphalan conditioning chemotherapy regime 4. Willing to have interviews audio-recorded

Exclusion Criteria

• 1. Currently using essential oils of any form (e.g. diffuser, topical application, massage rollers) 2. Known sensitivity/ allergy to essential oils 3. Any olfactory impairments (i.e. conditions that impair or alter sense of smell - for example, allergic rhinitis, chronic lung disease, blocked nose)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment Rate	From commencement of study (Day 1) to the end of treatment (Day 6)	Percentage of eligible patients who consent to join the study will be measured to evaluate the feasibility of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)
Retention Rate	From commencement of study (Day 1) to the end of treatment (Day 6)	Percentage of participants who complete the study will be measured to evaluate the feasibility of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)
Adherence rate	From commencement of study (Day 1) to the end of treatment (Day 6)	Percentage of participants in the intervention group who use the inhaler stick as instructed measured to evaluate the feasibility of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)
Patient-reported satisfaction	From commencement of study (Day 1) to the end of treatment (Day 6)	Measured through Likert-scale items at the end of the study to evaluate the acceptability of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)
Perceptions and Overall Experience	From commencement of study (Day 1) to the end of treatment (Day 6)	Qualitative insights from semi-structured interviews on ease of use, perceived helpfulness and overall experience to evaluate acceptability of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT)

Secondary Outcome Measures

Name	Time	Method
Severity of Nausea	From commencement of study (Day 1) to the end of treatment (Day 6)	Patient-reported nausea severity measured daily using a Visual Analog Scale (VAS, 0 = no nausea, 10 = worst possible nausea).
Frequency of Vomiting	From commencement of study (Day 1) to the end of treatment (Day 6)	Number of vomiting episodes recorded in patient journals and verified against electronic medical records
Use of Rescue Anti-Emetics	From commencement of study (Day 1) to the end of treatment (Day 6)	Frequency and dosage of rescue anti-emetic medication administered, retrieved from electronic medical records
Oral Intake	From commencement of study (Day 1) to end of treatment (Day 6)	Daily oral intake as documented in medical records as an indicator of nausea levels
Grading of Chemotherapy-Induced Nausea and Vomiting (CINV)	From commencement of study (Day 1) to end of treatment (Day 6)	Grading of CINV severity using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) on a 0-4 scale, where higher scores indicate more severe symptoms

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore