NCT07209501

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
May 2025Jun 2026

Study Start

First participant enrolled

May 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2026

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

October 2, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

aromatherapyChemotherapy-Induced Nausea and VomitingAutologous Haematopoietic Stem Cell Transplant

Outcome Measures

Primary Outcomes (5)

  • Recruitment Rate

    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)

    From commencement of study (Day 1) to the end of treatment (Day 6)

  • Retention Rate

    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)

    From commencement of study (Day 1) to the end of treatment (Day 6)

  • Adherence rate

    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)

    From commencement of study (Day 1) to the end of treatment (Day 6)

  • Patient-reported satisfaction

    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 hematopoietic stem cell transplant (HSCT). The Feasibility of intervention Likert-scale and the Acceptability of intervention Liker-scale will be used. The Likert-scale consist of a rating of 1- 5 where 1 is strongly disagree and 5 is strongly agree and to be rated by participants.

    From commencement of study (Day 1) to the end of treatment (Day 6)

  • Perceptions and Overall Experience

    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)

    From commencement of study (Day 1) to the end of treatment (Day 6)

Secondary Outcomes (5)

  • Severity of Nausea

    From commencement of study (Day 1) to the end of treatment (Day 6)

  • Frequency of Vomiting

    From commencement of study (Day 1) to the end of treatment (Day 6)

  • Use of Rescue Anti-Emetics

    From commencement of study (Day 1) to the end of treatment (Day 6)

  • Oral Intake

    From commencement of study (Day 1) to end of treatment (Day 6)

  • Grading of Chemotherapy-Induced Nausea and Vomiting (CINV)

    From commencement of study (Day 1) to end of treatment (Day 6)

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Participants in the control group will receive the placebo intervention in addition to standard care. Participants will be provided with an identical aromatherapy inhaler stick infused solely with jojoba oil. Jojoba oil, primarily used as a carrier oil for dilution, has little to- no scent and no known therapeutic or anxiolytic effects when inhaled. This ensures that any potential benefits observed in the intervention group can be attributed to the active essential oil blends rather than the inhalation process itself.

Other: Aromatherapy inhaler (placebo)

Intervention group

ACTIVE COMPARATOR

Participants in the intervention group will receive inhalation therapy via an aromatherapy inhaler stick\*, on top of standard care. Participants will be instructed to use the inhaler stick every four hours when they are awake, and whenever they feel nauseous, by holding the inhaler stick a finger's length away from their nostrils and inhaling through one nostril at a time. Each administration should not last more than 5 minutes. Participants will commence using the inhaler stick on the day of chemotherapy, until five days after the completion of chemotherapy (a total of six days).

Other: Aromatherapy inhaler

Interventions

Participants in the intervention group will receive inhalation therapy via an aromatherapy inhaler stick\*, on top of standard care. Participants will be instructed to use the inhaler stick every four hours when they are awake, and whenever they feel nauseous, by holding the inhaler stick a finger's length away from their nostrils and inhaling through one nostril at a time. Each inhaler administration should not last more than 5 minutes. Participants will commence using the inhaler stick on the day of chemotherapy, until five days after the completion of chemotherapy (total of six days). Given the subjective nature of scents, participants in the intervention group will be given a choice between two therapeutic aroma blends - N1 and N2 - before commencing the study. This approach aims to minimize the risk of negative associations with a particular scent and enhance participant adherence to the intervention.

Intervention group

Participants in the control group will receive the placebo intervention in addition to standard care. They will be provided with an identical aromatherapy inhaler stick infused solely with jojoba oil. Jojoba oil, primarily used as a carrier oil for dilution, has littleto- no scent and no known therapeutic or anxiolytic effects when inhaled.

Control Group

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cheryl Tay, Bachelor of Nursing

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2025

First Posted

October 7, 2025

Study Start

May 15, 2025

Primary Completion (Estimated)

June 23, 2026

Study Completion (Estimated)

June 24, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations