A Randomized Controlled Trial to Evaluate the Efficacy of Acupuncture Versus Aromatherapy as Treatments to Lessen Nausea, Vomiting and Anxiety Associated With Adriamycin and Cytoxan
Keywords
Abstract
Dates
| Last Verified: | 01/31/2020 |
| First Submitted: | 10/02/2019 |
| Estimated Enrollment Submitted: | 10/02/2019 |
| First Posted: | 10/06/2019 |
| Last Update Submitted: | 02/04/2020 |
| Last Update Posted: | 02/06/2020 |
| Actual Study Start Date: | 10/22/2019 |
| Estimated Primary Completion Date: | 02/28/2021 |
| Estimated Study Completion Date: | 02/28/2021 |
Condition or disease
Intervention/treatment
Other: Acupuncture with Anti-Emetics
Other: Aromatherapy with Anti-Emetics
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Acupuncture with Anti-Emetics | Other: Acupuncture with Anti-Emetics Acupuncture is a form of alternative medicine in which thin needles are inserted into the body. |
| Experimental: Aromatherapy with Anti-Emetics | Other: Aromatherapy with Anti-Emetics Aromatherapy is a form of alternative medicine in which you will inhale aromatic plant extracts and essential oils. |
| No Intervention: Control Group |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | i) Inclusion - At least 18 years of age on the day of signing informed consent - Patient has a diagnosis of breast cancer - Patient is planned to start Adriamycin and Cytoxan chemotherapy ii) Exclusion - Patients who are unable to adhere to the protocol or treatment schedule - Patients who have a concurrent illness or take medication that induces nausea independent of chemotherapy - Patients undergoing radiotherapy or hormone therapy during chemotherapy treatments - Patients who have a sensitive and/or poor sense of smell - Patients who are allergic to essential oils, specifically peppermint, ginger, and/or lavender - Patients who are already using essential oils or acupuncture for symptom management and are unwilling to stop while participating in this study - Patients who are afraid of or unwilling to receive acupuncture stimulation - Patients who are allergic to stainless steel needles - Thrombocytopenia (Platelets < 20,000) - Patients who have received aromatherapy and/or acupuncture treatment within 1 week of starting treatment on this study |
Outcome
Primary Outcome Measures
1. Improvement in Nausea [45 days]
2. improvement in anxiety [45 days]
3. improvement in vomiting [45 days]
