Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • neoadjuvant chemotherapy

    Other intervention

    The neoadjuvant chemotherapy plan will be selected according to the recommendations of the NCCN guidelines and the Chinese CSCO guidelines for early breast cancer.The neoadjuvant chemotherapy plans include:AC-T(HP),TCb(HP),AC-TCb, in which A represents anthracycline, C represents cyclophosphamide, T represents taxane, Cb represents carboplatin, H represents trastuzumab, and P represents pertuzumab.

  • aromatherapy

    Other intervention

    Patients will inhale essential oils during the neoadjuvant chemotherapy courses.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: neoadjuvant chemotherapyOther 1 intervention
Group B: neoadjuvant chemotherapy+aromatherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in anxiety score

Changes of anxiety scores (Hamilton Anxiety Scale and State-trait anxiety inventory scale) before and after two neoadjuvant chemotherapy courses.

Time frame
before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days)

Secondary outcomes

1

Overall Survival, OS

The time from the start of randomization to death due to any cause

Time frame
2 years
2

Quality of life scale score,QoL

The function or quality of a patient's physical, psychological, and social adaptability is also known as quality, which is assessed according to the EROTC C30 scale.

Time frame
before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days)
3

Pathologic complete response,pCR

Proportion of patients with pathologic complete response after neoadjuvant chemotherapy

Time frame
2 years
4

Disease-free survival,DFS

The time from diagnosis to first recurrence or death of the patient

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: