Kanglaite Reduce the Toxicity of Radiotherapy of Head and Neck Cancer Phase II Study

NCT03101514 | Completed Phase 2 Results

• 1 other identifier: 201708
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

About 89%-100% patients with head and neck malignant tumors have radiation mucositis during their radiotherapy. Until now, there is no effective method to prevent mucositis. Steroid hormone, pain-relief, anti-inflammatory and other symptom-relief treatments usually are used after the emergence of mucositis. Coixenol triglyceride is an ester extract of Coix Seed. Its trade name is Kanglaite Injection, which has been approved in China and Russia. Kanglaite has anti-tumor effect and reduce treatment toxicity of tumor. Kanglaite could also improve the quality of life of patients and mitigate the condition of the cachexia. In china, two studies evaluating treatment of Kanglaite to nasopharyngeal cancer, found that Kanglaite can reduce radiotherapy mucositis. So far, Kanglaite on the prevention and treatment of radiation mucositis of the head and neck malignant tumor is still lack of strong clinical trial evidence. This is a phase II, single center, one arm study with subject to evaluate the acute radiation mucositis, nutritional status, and quality of life on the course of radiotherapy of head and neck cancer.

Conditions

Head and Neck Cancer; Radiotherapy

Keywords

head and neck; tumor; radiotherapy; mucositis; toxicity; Kanglaite injection

Outcome Measures

Primary Outcomes (1)

• the Incidence Rate of Severe Radiation Mucositis

  The grade of radiation mucositis was assessed by CTCAE v4. The highest grade be recorded. The grade 1 was the best and grade 4 was the worst.

  From date of randomization until the end radiotherapy, up to 3 months.

Secondary Outcomes (5)

• the Incidence Rate of Non-Hematologic Toxicity Side Events

  From date of randomization until the end radiotherapy, up to 3 months.

• the Incidence Rate of Hematologic Toxicity Side Events

  From date of randomization until the end radiotherapy, up to 3 months.

• the Nutritional Status

  From date of randomization until the end radiotherapy, up to 3 months.

• the Overall Quality of Life (QOL)

  From date of randomization until the end radiotherapy, up to 3 months.

• Quality of Life Specific to Head and Neck Cancers

  From date of randomization until the end radiotherapy, up to 3 months.

Study Arms (1)

Kanglaite group

EXPERIMENTAL

Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy.

Drug: Kanglaite; Drug: chemotherapy

Interventions

Kanglaite DRUG

Kanglaite injection 200ml is injected intravenous from the first day to the last day of radiotherapy.

Also known as: Kanglaite injection

Kanglaite group

chemotherapy DRUG

Cisplatin 80-100mg/m2 was used every 3 weeks during radiotherapy.

Also known as: Concurrent chemotherapy

Kanglaite group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, expected survival period ≥ 12 months
• Karnofsky score ≥80 points
• Pathological confirmed head and neck malignant tumors (oral, oropharynx, hypopharynx, throat, nasopharynx, nasal paranasal sinus or other), radical radiotherapy (± chemotherapy) or postoperative radiotherapy (± chemotherapy), radiotherapy dose 60 -70Gy
• with or without induction chemotherapy (induced chemotherapy ≤ 3 cycles);
• Meet the following laboratory diagnostic indicators:
• Hemoglobin ≥120g / L, white blood cells 4.0-10.0 × 109 / L, neutrophils 2.0-7.5 × 109 / L, platelets 100-300 × 109 / L; creatinine ≤ normal upper limit (UNL); ALT and AST ≤ 2.5 × UNL, alkaline phosphatase (ALP) ≤ 5 × UNL, total bilirubin (Tbil) ≤ UNL
• Sign informed consent.

You may not qualify if:

• Distant metastases
• Allergy to Kanglaite
• Head and neck had previously received radiation therapy
• Pregnancy or lactation patients
• Targeted drug therapy during radiotherapy
• Radio-chemotherapy uses cytotoxic drugs other than platinum
• Currently active infections, or combined with rheumatic immune diseases, long-term chronic infection, acute infection, inflammatory state; hematopoietic dysfunction of the blood system diseases; severe cardiopulmonary disease
• Mental history, can not cooperate with the treatment
• Researchers believe unsuitable to participate in this trial.

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Related Publications (7)

• Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, Komaroff E, Nalysnyk L, Zilberberg MD. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8.

  PMID: 12742264 BACKGROUND

• Redding SW. Cancer therapy-related oral mucositis. J Dent Educ. 2005 Aug;69(8):919-29.

  PMID: 16081575 BACKGROUND

• Silverman S Jr. Diagnosis and management of oral mucositis. J Support Oncol. 2007 Feb;5(2 Suppl 1):13-21.

  PMID: 17366929 BACKGROUND

• Harris DJ. Cancer treatment-induced mucositis pain: strategies for assessment and management. Ther Clin Risk Manag. 2006 Sep;2(3):251-8. doi: 10.2147/tcrm.2006.2.3.251.

  PMID: 18360600 BACKGROUND

• Rodriguez-Caballero A, Torres-Lagares D, Robles-Garcia M, Pachon-Ibanez J, Gonzalez-Padilla D, Gutierrez-Perez JL. Cancer treatment-induced oral mucositis: a critical review. Int J Oral Maxillofac Surg. 2012 Feb;41(2):225-38. doi: 10.1016/j.ijom.2011.10.011. Epub 2011 Nov 8.

  PMID: 22071451 BACKGROUND

• Walsh L, Gillham C, Dunne M, Fraser I, Hollywood D, Armstrong J, Thirion P. Toxicity of cetuximab versus cisplatin concurrent with radiotherapy in locally advanced head and neck squamous cell cancer (LAHNSCC). Radiother Oncol. 2011 Jan;98(1):38-41. doi: 10.1016/j.radonc.2010.11.009. Epub 2010 Dec 13.

  PMID: 21159400 BACKGROUND

• Chen Y, Liu MZ, Liang SB, Zong JF, Mao YP, Tang LL, Guo Y, Lin AH, Zeng XF, Ma J. Preliminary results of a prospective randomized trial comparing concurrent chemoradiotherapy plus adjuvant chemotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma in endemic regions of china. Int J Radiat Oncol Biol Phys. 2008 Aug 1;71(5):1356-64. doi: 10.1016/j.ijrobp.2007.12.028. Epub 2008 May 9.

  PMID: 18472356 BACKGROUND

Related Links

• Jing JL, Li XL, Nan YQ. Advances in the study of the effect of Kanglaite injection on tumor therapy. Chinese Remedies \& Clinics, 2013;13(11):1447-1448 (in Chinese).
• Guo Y, Li DP. Protective effects of Kanglaite injection on hematopoiesis and liver and kidney damage caused by three anticancer drugs. Chinese journal of modern applied phaemacy.1998;15(6):61-62(in Chinese).
• Wang WD, Sun SP, Wang XD. Influence of KLT on Radiotherapy Effect of Patients with Advanced Nasopharyngeal Carcinoma. China Journal of Cancer Prevention and Treatment,2003:10(6): 635-637(in Chinese).
• Ren ZP, et al. The therapeutic effects of the combined therapy with kanglaite injection and radiotherapy on nasopharyngea carcinoma among aged cases. Chinese Journal of Otorhinolaryngology of Integrated Traditional and Western Medici 2005;13(6)

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms; Mucositis

Interventions

kang-lai-te; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Zhi-Ping Liu
• Organization: the first affiliated hospital of Harbin medical university

as150001@aliyun.com

+8613936034546

Study Officials

• Zhi-Ping Liu, MD

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Kanglaite injection + Radiotherapy ± Chemotherapy

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 5, 2017
• Study Start: January 1, 2017
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: June 23, 2021
• Results First Posted: June 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)