Aromatherapy for Chemotherapy-induced Symptoms

University of Rochester

Status and phase: Terminated; Early Phase 1

Conditions: Chemotherapy Symptoms

Treatments: Drug: Jojoba; Drug: Lavender; Drug: Ginger; Drug: Orange

Study type: Interventional

Funder types: Other

Identifiers

NCT02670941

RSRB57258

Details and patient eligibility

About

The rationale behind the proposed study is to determine the initial effectiveness of aromatherapy in relief of commonly reported symptoms in cancer patients undergoing chemotherapy.

Full description

The proposed study is an exploratory trial to evaluate the use of aromatherapy for symptom management in patients undergoing chemotherapy. The investigators will accrue 120 adult cancer subjects undergoing chemotherapy in a initial efficacy study to determine the effectiveness of three different aromatherapies (ginger, lavender, or orange) on chemotherapy-related symptoms (nausea, vomiting, pain, anxiety, sleep difficulties, fatigue, and lack of appetite) compared to placebo (i.e., jojoba). All subjects will be randomized to one of the four arms for symptom management during three different chemotherapy cycles. The investigators will examine the incidence and severity of the seven symptoms at each chemotherapy cycle. The preliminary data from this study will elucidate the relationships between certain aromatherapies and specific symptom relief, which can be further evaluated in a larger confirmatory study of subjects undergoing chemotherapy or other types of cancer treatment. This study will provide clinical evidence regarding the incorporation of aromatherapy into cancer patient care.

Enrollment: 31 patients

Sex: All

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-pregnant adults between the ages of 21 to 89 years of age with diagnosis of cancer and be scheduled to receive at least three more cycles of chemotherapy.
• Subjects must have had at least one chemotherapy cycle in their current prescribed course and have at least three additional chemotherapy cycles planned.
• Day 1 of each chemotherapy cycle must be separated from Day 1 of the next chemotherapy cycles by at least 12 days.
• All chemotherapy regimens are eligible.
• Any number of chemotherapy administrations per week during a chemotherapy treatment cycle is allowed.
• Subjects agree to discontinue any current aromatherapy usage and only use the study aromatherapy for symptom management during the course of the study. NOTE: Patients can continue to use scented soaps, lotions, shampoos, body sprays, perfume/cologne, candles, or air fresheners that they regularly use.
• Subjects must be able to read and understand English, as well as provide informed consent in order to participate in this study.

Exclusion criteria

• Subjects < 21 years old or > 89 years old are not eligible for participation in this study at the University of Rochester.
• Pregnant females are ineligible for the study because pregnancy is a contraindication for chemotherapy and exposure to essentials oils.
• Subjects who are chemotherapy-naïve are ineligible.
• Subjects with more than four weeks between chemotherapy treatment cycles are not eligible.
• Concurrent radiation therapy or interferon treatment is not allowed.
• Subjects that have used or are currently using aromatherapy inhalation for symptom management are not eligible.
• Subjects with any known allergy to ginger, lavender, orange, citrus of any kind, jojoba, or essential oils.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

31 participants in 4 patient groups, including a placebo group

Ginger

Experimental group

Description:

Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime).

Treatment:

Drug: Ginger

Lavender

Experimental group

Description:

Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime).

Treatment:

Drug: Lavender

Orange

Experimental group

Description:

Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime).

Treatment:

Drug: Orange

Jojoba

Placebo Comparator group

Description:

Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime).

Treatment:

Drug: Jojoba