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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

E

Englewood Hospital and Medical Center

Status

Completed

Conditions

Vomiting
Nausea
Anxiety

Treatments

Other: Acupuncture
Other: Aromatherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04116697
E-19-773

Details and patient eligibility

About

The overall goal of this study is to explore the effectiveness of using acupuncture versus aromatherapy, in conjunction with standard of care anti-emetics, to decrease chemotherapy induced nausea, vomiting, and anxiety in breast cancer patients undergoing Adriamycin and Cytoxan. This study also aims to determine if aromatherapy and anti-emetics is more effective than acupuncture and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving Adriamycin and Cytoxan and if acupuncture and anti-emetics is more effective than aromatherapy and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving Adriamycin and Cytoxan.

Enrollment

26 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 3 patient groups

Acupuncture with Anti-Emetics
Experimental group
Treatment:
Other: Acupuncture
Aromatherapy with Anti-Emetics
Experimental group
Treatment:
Other: Aromatherapy
Control Group
No Intervention group

Trial contacts and locations

1

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Central trial contact

Jamie Ketas

Data sourced from clinicaltrials.gov

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