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Published in: Trials 1/2020

Open Access 01-12-2020 | Breast Cancer | Study protocol

Does a ketogenic diet as an adjuvant therapy for drug treatment enhance chemotherapy sensitivity and reduce target lesions in patients with locally recurrent or metastatic Her-2-negative breast cancer? Study protocol for a randomized controlled trial

Authors: Yan Wang, Ming-Xi Jing, Lei Jiang, Yu-Feng Jia, E. Ying, Hui Cao, Xiang-Yu Guo, Tao Sun

Published in: Trials | Issue 1/2020

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Abstract

Background

Recent studies have indicated that a ketogenic diet can be used as an adjuvant therapy to enhance sensitivity to chemotherapy and radiotherapy in cancer patients. However, there are no sufficient data and no consistent international treatment guidelines supporting a ketogenic diet as an adjuvant therapy for metastatic breast cancer. Therefore, this trial was designed to observe whether irinotecan with a ketogenic diet can promote sensitivity to chemotherapy and remit target lesions in locally recurrent or metastatic Her-2-negative breast cancer patients.

Methods/design

This trial aims to recruit 518 women with locally recurrent or metastatic breast cancer admitted to the Liaoning Cancer Hospital and Institute (Shenyang, China) in northeast China. All patients will be randomly assigned into the combined intervention group (n = 259) or the control group (n = 259), followed by treatment with irinotecan + ketogenic diet or irinotecan + normal diet, respectively. The primary endpoints are sensitivity to irinotecan and the objective response rate of target lesions; the secondary endpoints include quality of life scores (EORTC QLQ-C30), progression-free survival, overall survival time, incidence of adverse events, and cost-effectiveness. The endpoints will be evaluated at baseline (before drug administration), during treatment, 4 weeks after treatment completion, and every 3months (beginning 2 months after treatment completion).

Discussion

This trial attempts to investigate whether irinotecan treatment with a ketogenic diet for locally recurrent or metastatic breast cancer among women in northeast China can enhance the disease’s sensitivity to chemotherapy and reduce target lesions.

Trial registration

Chinese Clinical Trial Registry, ID: ChiCTR1900024597​. Registered on 18 July 2019. Protocol Version: 1.1, 24 February 2017.
Appendix
Available only for authorised users
Literature
1.
Guo W, Hao B, Luo N, Ruan D, Guo X, Chen HJ, et al. Early re-staging and molecular subtype shift surveillance of locally recurrent or metastatic breast cancer: a new PET/CT integrated precise algorithm. Cancer Lett. 2018;418:221–9.CrossRef
2.
Meng XY, Song ST. Diagnosis and treatment of osteoblastic metastasis in patients with breast cancer. Zhonghua Zhong Liu Za Zhi. 2018;40:401–5.PubMed
3.
Bevers TB, Helvie M, Bonaccio E, Calhoun KE, Daly MB, Farrar WB, et al. Breast cancer screening and diagnosis, Version 3.2018, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Cancer Netw. 2018;16:1362–9.CrossRef
4.
Awada A, Garcia AA, Chan S, Jerusalem GH, Coleman RE, Huizing MT, et al. Two schedules of etirinotecan pegol (NKTR-102) in patients with previously treated metastatic breast cancer: a randomised phase 2 study. Lancet Oncol. 2013;14:1216–25.CrossRef
5.
Perez EA, Hillman DW, Mailliard JA, Ingle JN, Ryan JM, Fitch TR, et al. Randomized phase II study of two irinotecan schedules for patients with metastatic breast cancer refractory to an anthracycline, a taxane, or both. J Clin Oncol. 2004;22:2849–55.CrossRef
6.
Shigeoka Y, Itoh K, Igarashi T, Ishizawa K, Saeki T, Fujii H, et al. Clinical effect of irinotecan in advanced and metastatic breast cancer patients previously treated with doxorubicin- and docetaxel-containing regimens. Jpn J Clin Oncol. 2001;31:370–4.CrossRef
7.
Klement RJ, Sweeney RA. Impact of a ketogenic diet intervention during radiotherapy on body composition: I. initial clinical experience with six prospectively studied patients. BMC Res Notes. 2016;9:143.CrossRef
8.
Branca JJ, Pacini S, Ruggiero M. Effects of pre-surgical vitamin D supplementation and ketogenic diet in a patient with recurrent breast cancer. Anticancer Res. 2015;35:5525–32.PubMed
9.
Morscher RJ, Aminzadeh-Gohari S, Feichtinger RG, Mayr JA, Lang R, Neureiter D, et al. Inhibition of neuroblastoma tumor growth by ketogenic diet and/or calorie restriction in a CD1-Nu mouse model. PLoS One. 2015;10:e0129802.CrossRef
10.
Poff AM, Ari C, Seyfried TN, D'Agostino DP. The ketogenic diet and hyperbaric oxygen therapy prolong survival in mice with systemic metastatic cancer. PLoS One. 2013;8:e65522.CrossRef
11.
Smyl C. Ketogenic diet and cancer—a perspective. Recent Results Cancer Res. 2016;207:233–40.CrossRef
12.
Klement RJ, Champ CE, Otto C, Kämmerer U. Anti-tumor effects of ketogenic diets in mice: a meta-analysis. PLoS One. 2016;11:e0155050.CrossRef
13.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRef
14.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228–47.CrossRef
15.
Crozier JA, Advani PP, LaPlant B, Hobday T, Jaslowski AJ, Moreno-Aspitia A, et al. N0436 (Alliance): a phase II trial of irinotecan with cetuximab in patients with metastatic breast cancer previously exposed to anthracycline and/or taxane-containing therapy. Clin Breast Cancer. 2016;16:23–30.CrossRef
16.
İyikesici MS, Slocum AK, Slocum A, Berkarda FB, Kalamian M, Seyfried TN. Efficacy of metabolically supported chemotherapy combined with ketogenic diet, hyperthermia, and hyperbaric oxygen therapy for stage IV triple-negative breast cancer. Cureus. 2017;9:e1445.PubMedPubMedCentral
17.
Frommelt L, Bielohuby M, Stoehr BJ, Menhofer D, Bidlingmaier M, Kienzle E. Effects of low-carbohydrate, high-fat diets on apparent digestibility of minerals and trace elements in rats. Nutrition. 2014;30:869–75.CrossRef
18.
Jiang B, Zou DJ, Ma XH, Cheng XB, Lu Y, Chen LM, et al. Chinese expert consensus of ketogenic diet intervention for type 2 diabetes [in Chinese]. Shiyong Linchuang Yiyao Zazhi. 2019;23:1–6.
19.
Zhao FZ, Xiao SM, Zhao P. Correlation research of in vitro chemosensitivity of chemotherapy drugs in gastric cancer [in Chinese]. Chongqing Yixue. 2019;48:56–60.
20.
Zhao H, Kanda K. Testing psychometric properties of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30). J Epidemiol. 2004;14:193–203.CrossRef
21.
Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ, et al. Validity and reliability of the U.S. National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol. 2015;1:1051–9.CrossRef
22.
Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23:7794–803.CrossRef
23.
Little RJ, D’Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med. 2012;367:1355–60.CrossRef
24.
O’Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. Oncologist. 2015;10:20–9.CrossRef
Metadata
Title
Does a ketogenic diet as an adjuvant therapy for drug treatment enhance chemotherapy sensitivity and reduce target lesions in patients with locally recurrent or metastatic Her-2-negative breast cancer? Study protocol for a randomized controlled trial
Authors
Yan Wang
Ming-Xi Jing
Lei Jiang
Yu-Feng Jia
E. Ying
Hui Cao
Xiang-Yu Guo
Tao Sun
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04429-5

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