Electro-acupuncture for the Prevention and Treatment of Oxaliplatin-induced Neurotoxicity in Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

Official title:

Electro-acupuncture for the Prevention and Treatment of Oxaliplatin-induced Neurotoxicity in Colorectal Cancer Patients: a Prospective, Randomized, Sham-controlled, Double-blinded and Multicenter Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05798884
• Other study ID #: 2020HMRF
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2023
• Source: Hong Kong Baptist University
• Contact: Linda Zhong
• Phone: 852-34116523
• Email: ldzhong0305[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, a 24-week randomized, sham-controlled, single-blind, multicenter clinical trial will be conducted to explore the effect of electroacupuncture for prevention and treatment of both acute and chronic neurotoxicity through both clinical and biological indicators.

Description:

This is a prospective, randomized, sham-controlled, double-blinded and multiple center trial on electro-acupuncture for preventing and treating symptoms of chemotherapy-induced neurotoxicity in patients with colorectal cancer. A total of 150 candidates will be recruited in this study four weeks before chemotherapy for best preventive effect. They will be assigned randomly into either the electro-acupuncture or the sham-control group with 1:1 ratio. Both groups will receive a total of 24 sessions of interventions (4 weeks before chemotherapy and 8 weeks during chemotherapy, with 2 session per week), and will be followed up regularly for up to 12 weeks after completion of the acupuncture.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• are aged =18 years old;

• are newly diagnosed with stage II to IV colorectal cancer;

• going to receive adjuvant oxaliplatin-based chemotherapy within 4 weeks;

• had not received any acupuncture in the previous 3 months and had a life expectancy = of six months.

Exclusion Criteria:

• are not able to comprehend and communicate;

• are not able to read Chinese;

• have prior peripheral neuropathy caused by other diseases including diabetes, stroke, cardiovascular diseases such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers;

• have a bleeding tendency;

• are pregnant or breastfeeding;

• have impaired hepatic or renal function;

• using any pharmaceutical agents e.g., vitamin B6 and vitamin E, or herbal medication. All the above medication prescribed by physicians or Chinese medicine practitioners during the study will be recorded.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Electro-acupuncture
• Neurotoxicity
• Neurotoxicity Syndromes
• Oxaliplatin

Intervention

Device:
• Acupuncture
Disposable acupuncture needles (0.25 mm in diameter and 25 mm in length) are straightly into body acupuncture points (he gu (LI4), nei guan (PC6), qu chi (LI12), ba xie (EX-UE9), zu san li (ST36), san yin jiao (SP6), tai chung (LV3) and ba feng (EX-LE10)). The use of ba xie (EX-UE9) and ba feng (EX-LE10) will be optional if skin lesions of hands and feet occur due to Capecitabine (Xeloda). Electrical stimulation will be delivered with continuous waves at 2 Hz, at an intensity of each patient's minimum sensation of stimulation through the electrical acupuncture stimulation instrument. The needles will be retained in position for 25 minutes.
• Sham-acupuncture
Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2"/ 0.30 x 30mm) will be applied to serve as a sham control at the same acupoints with the same stimulation modality and then connecting the needle to the incorrect output socket of the electrical acupuncture stimulation instrument. The sham points are "pseudo stimulation".

Locations

Country	Name	City	State
Hong Kong	Linda Zhong	Kowloon Tong	Kowloon

Sponsors (3)

Lead Sponsor	Collaborator
Hong Kong Baptist University	Princess Margaret Hospital, Hong Kong, Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (26)

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. — View Citation

Brami C, Bao T, Deng G. Natural products and complementary therapies for chemotherapy-induced peripheral neuropathy: A systematic review. Crit Rev Oncol Hematol. 2016 Feb;98:325-34. doi: 10.1016/j.critrevonc.2015.11.014. Epub 2015 Nov 23. — View Citation

Calhoun EA, Welshman EE, Chang CH, Lurain JR, Fishman DA, Hunt TL, Cella D. Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy. Int J Gynecol Cancer. 2003 Nov-Dec;13(6):741-8. doi: 10.1111/j.1525-1438.2003.13603.x. — View Citation

Chan K, Lui L, Yu K, Lau K, Lai M, Lau W, Ng B, Zhong LLD, Bian ZX. The efficacy and safety of electro-acupuncture for alleviating chemotherapy-induced peripheral neuropathy in patients with coloreactal cancer: study protocol for a single-blinded, randomized sham-controlled trial. Trials. 2020 Jan 9;21(1):58. doi: 10.1186/s13063-019-3972-5. — View Citation

Derksen TM, Bours MJ, Mols F, Weijenberg MP. Lifestyle-Related Factors in the Self-Management of Chemotherapy-Induced Peripheral Neuropathy in Colorectal Cancer: A Systematic Review. Evid Based Complement Alternat Med. 2017;2017:7916031. doi: 10.1155/2017/7916031. Epub 2017 Mar 16. — View Citation

El-Fatatry BM, Ibrahim OM, Hussien FZ, Mostafa TM. Role of metformin in oxaliplatin-induced peripheral neuropathy in patients with stage III colorectal cancer: randomized, controlled study. Int J Colorectal Dis. 2018 Dec;33(12):1675-1683. doi: 10.1007/s00384-018-3104-9. Epub 2018 Jun 21. — View Citation

Engstrom PF, Arnoletti JP, Benson AB 3rd, Chen YJ, Choti MA, Cooper HS, Covey A, Dilawari RA, Early DS, Enzinger PC, Fakih MG, Fleshman J Jr, Fuchs C, Grem JL, Kiel K, Knol JA, Leong LA, Lin E, Mulcahy MF, Rao S, Ryan DP, Saltz L, Shibata D, Skibber JM, Sofocleous C, Thomas J, Venook AP, Willett C; National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: colon cancer. J Natl Compr Canc Netw. 2009 Sep;7(8):778-831. doi: 10.6004/jnccn.2009.0056. No abstract available. — View Citation

Fleckenstein J, Baeumler PI, Gurschler C, Weissenbacher T, Simang M, Annecke T, Geisenberger T, Irnich D. Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial. Trials. 2014 Jul 21;15:292. doi: 10.1186/1745-6215-15-292. — View Citation

Gewandter JS, Dworkin RH, Finnerup NB, Mohile NA. Painful chemotherapy-induced peripheral neuropathy: lack of treatment efficacy or the wrong clinical trial methodology? Pain. 2017 Jan;158(1):30-33. doi: 10.1097/j.pain.0000000000000653. No abstract available. — View Citation

Greenlee H, Crew KD, Capodice J, Awad D, Buono D, Shi Z, Jeffres A, Wyse S, Whitman W, Trivedi MS, Kalinsky K, Hershman DL. Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in women with early stage breast cancer. Breast Cancer Res Treat. 2016 Apr;156(3):453-464. doi: 10.1007/s10549-016-3759-2. Epub 2016 Mar 25. — View Citation

Griffith KA, Dorsey SG, Renn CL, Zhu S, Johantgen ME, Cornblath DR, Argyriou AA, Cavaletti G, Merkies IS, Alberti P, Postma TJ, Rossi E, Frigeni B, Bruna J, Velasco R, Kalofonos HP, Psimaras D, Ricard D, Pace A, Galie E, Briani C, Dalla Torre C, Faber CG, Lalisang RI, Boogerd W, Brandsma D, Koeppen S, Hense J, Storey DJ, Kerrigan S, Schenone A, Fabbri S, Valsecchi MG; CI-PeriNomS Group. Correspondence between neurophysiological and clinical measurements of chemotherapy-induced peripheral neuropathy: secondary analysis of data from the CI-PeriNomS study. J Peripher Nerv Syst. 2014 Jun;19(2):127-35. doi: 10.1111/jns5.12064. — View Citation

Han X, Wang L, Shi H, Zheng G, He J, Wu W, Shi J, Wei G, Zheng W, Sun J, Huang H, Cai Z. Acupuncture combined with methylcobalamin for the treatment of chemotherapy-induced peripheral neuropathy in patients with multiple myeloma. BMC Cancer. 2017 Jan 9;17(1):40. doi: 10.1186/s12885-016-3037-z. — View Citation

Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL; American Society of Clinical Oncology. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014 Jun 20;32(18):1941-67. doi: 10.1200/JCO.2013.54.0914. Epub 2014 Apr 14. — View Citation

Hospital Authority. Hong Kong Cancer Registry. https://www3.ha.org.hk/cancereg/ (accessed on 29 March 2021)

Huang HQ, Brady MF, Cella D, Fleming G. Validation and reduction of FACT/GOG-Ntx subscale for platinum/paclitaxel-induced neurologic symptoms: a gynecologic oncology group study. Int J Gynecol Cancer. 2007 Mar-Apr;17(2):387-93. doi: 10.1111/j.1525-1438.2007.00794.x. — View Citation

Lam CL, Tse EY, Gandek B. Is the standard SF-12 health survey valid and equivalent for a Chinese population? Qual Life Res. 2005 Mar;14(2):539-47. doi: 10.1007/s11136-004-0704-3. — View Citation

Lu Z, Moody J, Marx BL, Hammerstrom T. Treatment of Chemotherapy-Induced Peripheral Neuropathy in Integrative Oncology: A Survey of Acupuncture and Oriental Medicine Practitioners. J Altern Complement Med. 2017 Dec;23(12):964-970. doi: 10.1089/acm.2017.0052. Epub 2017 Jun 29. — View Citation

Man SC, Hung BH, Ng RM, Yu XC, Cheung H, Fung MP, Li LS, Leung KP, Leung KP, Tsang KW, Ziea E, Wong VT, Zhang ZJ. A pilot controlled trial of a combination of dense cranial electroacupuncture stimulation and body acupuncture for post-stroke depression. BMC Complement Altern Med. 2014 Jul 19;14:255. doi: 10.1186/1472-6882-14-255. — View Citation

Rostock M, Jaroslawski K, Guethlin C, Ludtke R, Schroder S, Bartsch HH. Chemotherapy-induced peripheral neuropathy in cancer patients: a four-arm randomized trial on the effectiveness of electroacupuncture. Evid Based Complement Alternat Med. 2013;2013:349653. doi: 10.1155/2013/349653. Epub 2013 Aug 28. — View Citation

Sato J, Mori M, Nihei S, Takeuchi S, Kashiwaba M, Kudo K. Objective evaluation of chemotherapy-induced peripheral neuropathy using quantitative pain measurement system (Pain Vision(R)), a pilot study. J Pharm Health Care Sci. 2017 Jul 25;3:21. doi: 10.1186/s40780-017-0089-4. eCollection 2017. — View Citation

Shin KM, Kim JH, Lee S, Shin MS, Kim TH, Park HJ, Lee MH, Hong KE, Lee S, Choi SM. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial. Trials. 2013 Jun 14;14:174. doi: 10.1186/1745-6215-14-174. — View Citation

Tofthagen C, Donovan KA, Morgan MA, Shibata D, Yeh Y. Oxaliplatin-induced peripheral neuropathy's effects on health-related quality of life of colorectal cancer survivors. Support Care Cancer. 2013 Dec;21(12):3307-13. doi: 10.1007/s00520-013-1905-5. Epub 2013 Aug 1. — View Citation

Wang X, Wei G, Huo J. Chinese medicine for prevention and treatment of oxaliplatin-induced peripheral neuropathy. Jilin J Chinese Med 2013; 5: 465-467.

Wong W, Lam CL, Su YC, Lin SJ, Ziea ET, Wong VT, Wai LK, Kwan AK. Measuring body constitution: validation of the Body Constitution Questionnaire (BCQ) in Hong Kong. Complement Ther Med. 2014 Aug;22(4):670-82. doi: 10.1016/j.ctim.2014.05.009. Epub 2014 May 27. — View Citation

Wong W, Lam CL, Wong VT, Yang ZM, Ziea ET, Kwan AK. Validation of the constitution in chinese medicine questionnaire: does the traditional chinese medicine concept of body constitution exist? Evid Based Complement Alternat Med. 2013;2013:481491. doi: 10.1155/2013/481491. Epub 2013 Apr 24. — View Citation

Xie CC, Wen XY, Jiang L, Xie MJ, Fu WB. Validity of the "streitberger" needle in a chinese population with acupuncture: a randomized, single-blinded, and crossover pilot study. Evid Based Complement Alternat Med. 2013;2013:251603. doi: 10.1155/2013/251603. Epub 2013 Aug 1. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score Changes on the FACT/GOG-Ntx questionnaire	The questionnaire includes 11 questions covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy, which results in a cumulative score ranging from 0 to 44, with the lower scores reflecting worse neuropathy symptoms.	0-24 weeks; weekly
Secondary	numerical rating scale (NRS)	Patients will be asked to rate their average neuropathy symptoms within one week, on an 0 to 10 scale (0=no symptoms; 10=worst possible symptoms), those <4 of 10 NRS will be considered as mild neuropathy while =4 of 10 NRS will be considered as moderate to severe neuropathy.	0-24 weeks; weekly
Secondary	European Organization for Research and Treatment of Cancer (EORCTC) quality of life questionnaire QLQ-C30	A 30-items questionnaire assessing five functional scales (physical, role, cognitive, emotional and social), three symptoms scales (fatigue, pain, nausea and vomiting), and other symptoms and problem in cancer patients (dyspnoea, appetite loss, insomnia, constipation, diarrhoea, and financial difficulties).	0,3,6,9,12,15,18,21,24 weeks
Secondary	Constitution of Chinese Medicine Questionnaire (CCMQ)	CCMQ has 60 items measuring the 9 body constitution types: gentleness, Qi-deficiency, Yang-deficiency, Yin-deficiency, phlegm-wetness, wetness-heat, blood-stasis, Qi-depression, and special diathesis.	0,12,24 weeks
Secondary	Vibration sense test	It will be assessed using the graduated Rydel-Seiffer tuning fork (U.S. Neurologicals, Poulsbo, WA), with printed directions for use and its normative data. Readings will be averaged and recorded as the vibration value.	0-12 week; weekly
Secondary	Light touch test	It will be assessed with standard 10g monofilaments, contained within the Neuropen (Owen Mumford, Woodstock, UK). During testing, the fiber will be applied perpendicular to the plantar surface of the great toe and the palmar surface of the index finger until the fiber begins to bend and will be held in place for 1 second and then removed. This procedure will be repeated 3 times and the patient will be asked to report the ability to feel the fibe.	0-12 week; weekly
Secondary	Short Form 12 item(version 2) Health Survey (SF-12V2)	The SF-12V2 is a widely used generic HRQoL instrument, and its Chinese version has been validated and normed in the general Chinese population in Hong Kong. It consists of 12 questions measuring eight domains of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The scores are generated using an algorithm to generate a combined physical and mental health score for comparison with normative data. In the normative data: 1) the mean score was set to 50; 2) a score > 50 indicated better physical or mental health than the mean; 3) a score < 50 indicated worse physical or mental health than the mean.	0-12 week; weekly

External Links

•   accessed on 29 March 2021