Advanced Search

Journal of Traditional Chinese Medicine >

2022 , Vol. 42 >Issue 2: 289 - 295

DOI: https://doi.org/10.19852/j.cnki.jtcm.2022.02.008

Research Articles

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

  • Mahasti Saghachian ,
  • Caroline Barry ,
  • Bernard Asselain ,
  • Yunfen LI ,
  • Jianyun NIE ,
  • Dequan LIU ,
  • Dedian CHEN ,
  • Chunxin CHEN ,
  • Estevez Laura ,
  • Wenhui LI ,
  • Armand Jean-Pierre ,
  • Miansheng ZHU ,
  • Liya JU
Expand
  • 1 Institute Gustave Roussy, Paris, France
    2 Research Center of Epidemiology and public health, Paris, France
    3 Institute Curie of Paris, Paris, France
    4 Yunnan Cancer Hospital, Third Affiliated Hospital of Kunming Medical University, Kunming, China
    5 PreciMed Platform Europe, Paris, France
    6 MD Anderson Cancer Hospital, Madrid, Spain
    7 ARIATAS Association pour la Recherche et l’ Information de l’ Acupuncture Time-Acupoints-Space, Paris, France; Yunnan Zhu's expert workstation, National famous traditional Chinese medicine expert of Mian-Sheng ZHU, Kunming, China
LI Wenhui, Yunnan Province Cancer Hospital, Kunming, China. wenhuili2014@163.com, Telephone: +86-875-68179408
JU Liya, PreciMed Platform Europe, Paris, France. juliya_eiffel@126.com;

Received date: 2021-06-21

  Accepted date: 2021-09-23

  Online published: 2022-02-22

Supported by

PreciMed Platform Europe; a Financial Support from France Ruban Rose; the Pilot Clinical Study at Kunming Site was Granted By Yunnan Provincial Science and Technology Department Funding(2018IA059)

Fold

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

Cite this article

Mahasti Saghachian , Caroline Barry , Bernard Asselain , Yunfen LI , Jianyun NIE , Dequan LIU , Dedian CHEN , Chunxin CHEN , Estevez Laura , Wenhui LI , Armand Jean-Pierre , Miansheng ZHU , Liya JU . 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 . DOI: 10.19852/j.cnki.jtcm.2022.02.008

References

1. Parkin DM, Fernández LMG. Use of statistics to assess the global burden of breast cancer. Breast J 2006; 12: S70-80.
2. Chen W, Zheng R, Zeng H, Zhang S. The incidence and mortality of major cancers in China, 2012. Chin J Cancer 2016; 35: 430-4.
3. Chen WQ, Zheng RS, Baade PD, et al. Cancer statistics in China, 2015. CA Cancer J Clin 2016; 66: 115-32.
4. Goldhirsch A, Winer EP, Coates AS, et al. Personalizing the treatment of women with early breast cancer: highlights of the st gallen international expert consensus on the primary therapy of early breast cancer 2013. Ann Oncol 2013; 24: 2206-23.
5. Mieog JS, van der Hage JA, van de Velde CJ. Preoperative chemotherapy for women with operable breast cancer. Cochrane Database Syst Rev 2007; 7: CD005002.
6. Senkus E, Kyriakides S, Ohno S, et al. Primary breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2015; 26: v8-30.
7. Campos MP, Hassan BJ, Riechelmann R, Del Giglio A. Cancer-related fatigue: a practical review. Ann Oncol 2011; 22: 1273-9.
8. Butt Z, Rosenbloom SK, Abernethy AP, et al. Fatigue is the most important symptom for advanced cancer patients who have had chemotherapy. J Natl Compr Canc Netw 2008; 6: 448-55.
9. Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life. J Clin Oncol 2000; 18: 743-53.
10. Goldstein D, Bennett BK, Webber K, et al. Cancer-related fatigue in women with breast cancer: outcomes of a 5-year prospective cohort study. J Clin Oncol 2012; 30: 1805-12.
11. Mock V, Atkinson A, Barsevick A, et al. NCCN practice guidelines for cancer-related fatigue. Oncology (Williston Park) 2000; 14: 151-61.
12. Lehmann H. Acupuncture in ancient China: how important was it really? J Integr Med 2013; 11: 45-53.
13. Ma Z. Analysis of syndrome characteristics and related factors of CRF in patients with breast cancer. Beijing: Beijing University of Chinese Medicine, 2010: 7- 9, 33-9.
14. Savard M-H, Savard J, Simard S, Ivers H. Empirical validation of the insomnia severity index in cancer patients. Psychooncology 2005; 14: 429-41.
15. Smets EM, Garssen B, Bonke B, De Haes JC. The multidimensional fatigue inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res 1995; 39: 315-25.
16. Tian J, Hong JS. Validation of the Chinese version of multidimensional fatigue inventory-20 in Chinese patients with cancer. Support Care Cancer 2012; 20: 2379-83.
17. Fillion L, Gélinas C, Simard S, Savard J, Gagnon P. Validation evidence for the French Canadian adaptation of the multidimensional fatigue inventory as a measure of cancer-related fatigue. Cancer Nurs 2003; 26: 143-54.
18. Munguía-Izquierdo D, Segura-Jiméne V, Camiletti-Moirón D, et al. Multidimensional fatigue inventory: Spanish adaptation and psychometric properties for fibromyalgia patients. The Al-Andalus study. Clin Exp Rheumatol 2012; 30: 94-102.
19. Johnston M, Pollard B, Hennessey P. Construct validation of the hospital anxiety and depression scale with clinical populations. J Psychosom Res 2000; 48: 579-84.
Options
Outlines

/

〈 〉