Aromatherapy in the Treatment of Early Breast Cancer
ConditionEarly Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About this trial
Breast cancer is a major threat to women's health, and chemotherapy is one of the most important treatment method. Chemotherapy is cytotoxic , and has a positive tumor immune effect. However, it is worth noting that anxiety caused by breast cancer itself and adverse reactions of chemotherapy not only affects the patients' quality of life, but also reduces the treatment compliance and even survival benefits of patients. Previous literatures have shown that aromatherapy may improve chemotherapy-induced anxiety and even affect anti-tumor immunity.
Therefore,we envisage that aromatherapy conbimed with chemotherapy in the treatment of breast cancer in clinical practice has the advantages of improving efficacy and survival.
However, there is still a lack of relevant clinical studies. We planned to design a prospective clinical trial to evaluate the efficacy and safety of aromatherapy combined with chemotherapy on anxiety, relevant sympathetic neurotransmitters and tumor immunity in breast cancer patients.
Eligibility criteria
Qualifiers
Adult female patients (age 18-80 years) with early breast cancer confirmed by pathology.
Patients have not received any anti-tumor treatment,and are planning to receive neoadjuvant chemotherapy.
Patients with mild anxiety scored 50 in Self-Rating Anxiety Scale.
ECOG physical status score ≤ 2 and expected survival of not less than 3 months.
Disqualifiers
Patients who are not able to receive aromatherapy:be allergic to aromatherapy materials or suffer from heterosmia.
Received surgery within 2 weeks prior to enrollment.
Patients with severe cardiovascular and cerebrovascular events within 12 months, including but not limited to unstable angina, myocardial infarction, cerebral hemorrhage, and cerebral infarction (except asymptomatic lacunar infarction requiring no treatment)
Patients with active autoimmune diseases requiring treatment (e.g., corticosteroids or immunosuppressive drugs) within the past 2 years. Patients who need corticosteroid replacement therapy for adrenal insufficiency were excluded.
Trial design
Treatments tested in this trial
- neoadjuvant chemotherapy
- aromatherapy
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov