A single institution clinical trial to verify the utility of aroma Lymphatic tressage for edema of lower extremities associated with the taxane chemotherapy in patients with breast cancer

A single institution clinical tril to verify the utility of aroma Lymphatic tressage for edema of lower extremities associated with the taxane chemotherapy in patients with breast cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005951

Enrollment

Registered

2021-03-04

Start date

2019-08-13

Completion date

Unknown

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : Start the first Aroma Lymphatic Trisage (ALT) within 7 days after the baseline evaluation. A total of 8 treatments are performed twice a week for 40 minutes each for 1 month. Aroma Lymphatic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with breast cancer who are indicated for taxane treatmentn (regardless of adjuvant or palliative purpose) (AC followed by Docetaxel/Paclitaxel, AC followed by Docetaxel/Paclitaxel + Trastuzumab, TAC, TC, TCHP, Docetaxel/Paclitaxel monotherapy, Paclitaxel+Cisplatin, Paclitaxel+Carboplatin, Docetaxel+Epirubicin, Paclitaxel+Ifosfamide) 2. Patients within 6 weeks after completion of treatment with taxane anticancer drugs (Docetaxel, paclitaxel) 3. Patients with lower extremity edema of CTCAE v5.0 Generalized edema grade 2 or higher after taxane administration 4. Over 20 years old 5. A person who agrees to the subject explanation and consent form 6. A person who can fill out a questionnaire in Korean according to the standards. 7. A person who is willing to comply with the research plan and adhere to the treatment plan during the research period.

Exclusion criteria

Exclusion criteria: 1. Patients with known side effects of Taxane-based anticancer drugs. 2. Patients with soft tissue infection at the massage site 3. Patients with extensive bone metastases 4. Patients with severe musculoskeletal disorders or peripheral vascular disease, as judged by the researcher 5. Those who are currently receiving massage care. 6. History of major surgery or severe trauma within 28 days of study start. 7. Substance abusers who are judged to interfere with research participation and interpretation of research results Those with medical/psychiatric/social diseases. 8. According to the researcher's judgment, a patient who has a medical condition that may increase the risk due to participation in the study or interfere with the interpretation of the study results, or who have abnormal laboratory test values.

Design outcomes

Primary

Measure	Time frame
FACT TAXANE survey;the circumference of lower extremities (minimum circumference of thigh and calf)	—

Secondary

Measure	Time frame
EORTC-QLQ-C30 survey;Patient-reported degree of swelling;Cellulite film paper measurement	—

Countries

Korea, Republic of

Contacts

Public ContactJuwon Kim

Korea University Anam Hospital

Outcome results