An international multicentric phase Ⅲ randomized controlled trial of time-acupoints-space acupuncture for the prevention of chemotherapy-induced fatigue in patients with early stage breast cancer: a study protocol

doi:10.19852/j.cnki.jtcm.2022.02.008

Abstract

Abstract:

OBJECTIVE: To determine the difference in prevention of chemotherapy-induced fatigue between time-acupoints-space acupuncture (ATAS) administered weekly compared to sham acupuncture and non-acupuncture in patients with early breast cancer receiving adjuvant chemotherapy by epirubicine-cyclophosphamide (EC) followed by paclitaxel, as measured by the multi-dimensional fatigue inventory (MFI) over the previous week and Visual Analogue Scale measuring fatigue (VAS-F), and to evaluate the effects of ATAS on self-reported neuropathy pain, sleep, anxiety and depression.

METHODS: In this multicenter clinical trial, we have randomized patients into 3 groups: ATAS, Sham and non-acupuncture with an unequal randomization of 2∶1∶1. A cloud related electronical clinical report form and smartphone platform was established for data entry. Patients with a history of stage Ⅰ-Ⅲ breast cancer scheduled to receive adjuvant chemotherapy. Acupuncture will be delivered once a week during chemotherapy with VAS-F evaluation. In order to qualify and quantify the mechanism of fatigue induced by chemotherapy with or without acupuncture, an evaluation of immune profiling was incorporate in this study.

RESULTS: The presence and seriousness of chemotherapy-induced fatigue should be considered in therapeutic programs for early breast cancer treatment. Fatigue induced by adjuvant chemotherapy in patients with breast cancer remains a major concern affecting the quality of life significantly. Unfortunately, we do not have effective pharmacological interventions yet. And clinical trials of acupuncture in preventing chemotherapy-induced fatigue in patients with early breast cancer have not been reported.

CONCLUSION: The findings of the trial will allow us to determine the effects of acupuncture treatment approach. We will also be able to confirm whether ATAS is better than sham acupuncture and non-acupuncture treatments.

Key words: breast neoplasms, chemotherapy, adjuvant, fatigue, immunity, clinical protocols, time-acupoints-space acupuncture

Saghachian Mahasti, Barry Caroline, Asselain Bernard, LI Yunfen, NIE Jianyun, LIU Dequan, CHEN Dedian, CHEN Chunxin, Laura Estevez, LI Wenhui, Jean-Pierre Armand, ZHU Miansheng, JU Liya. An international multicentric phase Ⅲ randomized controlled trial of time-acupoints-space acupuncture for the prevention of chemotherapy-induced fatigue in patients with early stage breast cancer: a study protocol[J]. Journal of Traditional Chinese Medicine, 2022, 42(2): 289-295.

Figures/Tables 5

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Center	EC	T
Center	Epirubicin + cyclophosphamide	Paclitaxel
Paris: Gustave Roussy Cancer Institute	E90 mg/m² + C600 mg/m², q3w×4	80 mg/m²,q1w × 12
Kunming: Yunnan Cancer Hospital	E90 mg/m² + C 600 mg/m², q3w×4	175 mg/m², q3w × 4
Madrid: MD Anderson Madrid	E90 mg/m² + C600 mg/m², q3w×4	100 mg/m², q1w × 8

Center	EC	T
Center	Epirubicin + cyclophosphamide	Paclitaxel
Paris: Gustave Roussy Cancer Institute	E90 mg/m² + C600 mg/m², q3w×4	80 mg/m²,q1w × 12
Kunming: Yunnan Cancer Hospital	E90 mg/m² + C 600 mg/m², q3w×4	175 mg/m², q3w × 4
Madrid: MD Anderson Madrid	E90 mg/m² + C600 mg/m², q3w×4	100 mg/m², q1w × 8

Assessment	Time points
Assessment	T1	T2	T3	T4
Multidimensional Fatigue Inventory (MFI)	×	×	×	×
Visual Analogue Scale measuring fatigue (VAS-F)	×	×	×	×
Hospital Anxiety and Depression Scale (HADS)	×	×	×	×
FACT/GOG-NTX (VERSION 4) (Functional Assessment of Cancer Therapy - Gynecologic Oncology Group)	×	×	×	×
Sleep quality: Insomnia Severity Index (ISI)	×	×	×	×
Serum hormones and inflammatory markers	×	×	×	×

Assessment	Time points
Assessment	T1	T2	T3	T4
Multidimensional Fatigue Inventory (MFI)	×	×	×	×
Visual Analogue Scale measuring fatigue (VAS-F)	×	×	×	×
Hospital Anxiety and Depression Scale (HADS)	×	×	×	×
FACT/GOG-NTX (VERSION 4) (Functional Assessment of Cancer Therapy - Gynecologic Oncology Group)	×	×	×	×
Sleep quality: Insomnia Severity Index (ISI)	×	×	×	×
Serum hormones and inflammatory markers	×	×	×	×

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