A Phase 2 interventional study of Kanglaite and chemotherapy in Head and Neck Cancer and Radiotherapy, sponsored by First Affiliated Hospital of Harbin Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-23.
Sponsored by First Affiliated Hospital of Harbin Medical University · Phase 2, Interventional, and Prevention
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.
3-4 grade radiation mucositis account for 34%-56% in all head and neck patients treated by radiotherapy and >50% in patients treated by radiotherapy concurrent with chemotherapy. 3-4 grade radiation mucositis have obvious symptoms, presenting with fusion ulcers, ulcers bleeding or obvious pain need analgesic drugs. At this time, the patients can not eat or can only intake fluid diet, which led to weight loss, malnutrition, quality of life declined and a series of problems.
Kanglaite has anti-tumor effect and reduce treatment toxicity of tumor. Kanglaite can reduce radiotherapy mucositis of nasopharyngeal cancer had been found initially in Chinese. 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 evaluation the acute radiation mucositis, nutritional status, and quality of life on the course of radiotherapy of head and neck malignant tumors.
Kanglaite 200ml is injected intravenous from the first day to the last day of radiotherapy. Chemotherapy with cisplatin or nedaplatin (both 80-100mg/m2, 21 day per cycle, 1-3 cycles) is used or not concurrent with radiotherapy. There is no order of Kanglaite injection and radiotherapy. Granulocyte colony stimulating factor and antibiotics have no prophylactic use, but can be used after the decline of white blood cells. Mucositis, nutritional status, and quality of life are evaluated before radiotherapy, every week of radiotherapy, 4 weeks after radiotherapy. Mucositis is verified by physical examination. Nutritional status is evaluated by patient-generated subjective global assessment (PG-SGA) scale. Quality of life is evaluated by EORTC QLQ-C30 and QLQ-H\&N35 questionnaire.
This is a one arm study, sample size calculation based on the incidence of 3-4 degree mucositis. The incidence of 3-4 degree mucositis is about >50% according to literatures of head and neck squamous cell carcinoma intensity modulated radiation therapy concurrent with chemotherapy. So we assume that Kanglaite can reduce 3-4 degree mucositis from 50% to 30%. The sample size required 44 cases according to the superiority test, bilateral Class I error α = 0.05, class II error β = 0.2. Total 49 cases are need, assuming the off rate of 10%.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 53 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →First Affiliated Hospital of Harbin Medical University is the lead sponsor of 73 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy.
Drug: Kanglaite · Drug: chemotherapy
Kanglaite injection 200ml is injected intravenous from the first day to the last day of radiotherapy.
Also known as: Kanglaite injection
Cisplatin 80-100mg/m2 was used every 3 weeks during radiotherapy.
Also known as: Concurrent chemotherapy
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.
Time frame: From date of randomization until the end radiotherapy, up to 3 months.
the Incidence Rate of Non-Hematologic Toxicity Side Events
The non-hematologic toxicity side events were assessed by CTCAE v4. The highest grade be recorded. The grade 1 was the best and grade 4 was the worst.
Time frame: From date of randomization until the end radiotherapy, up to 3 months.
the Incidence Rate of Hematologic Toxicity Side Events
The grade of hematologic toxicity side events were assessed by CTCAE v4. The highest grade be recorded. The grade 1 was the best and grade 4 was the worst.
Time frame: From date of randomization until the end radiotherapy, up to 3 months.
the Nutritional Status
The nutritional status was assessed by PG-SGA questionnaire.PG-SGA scores were recorded weekly during radiotherapy. A score of 0-1 indicated good nourishment, 2-8 suspected or moderate malnutrition, ≥ 9 risk of severe malnutrition.
Time frame: From date of randomization until the end radiotherapy, up to 3 months.
the Overall Quality of Life (QOL)
The overall quality of life was assessed by EORTC QLQ-C30 questionnaire. QLQ-C30 scores were valued weekly during radiotherapy and post radiotherapy.The worst score of patients was recorded. The QLQ-C30 was scored from 0 to 100. Higher scores for function indicated a better QOL whereas the symptoms indicated a worsening QOL.
Time frame: From date of randomization until the end radiotherapy, up to 3 months.
Quality of Life Specific to Head and Neck Cancers
Quality of life specific to head and neck cancers was assessed by EORTC QLQ-H\&N35 questionnaire. QLQ-H\&N35 scores were valued weekly during radiotherapy and post radiotherapy. The highest score of patients was recorded. The QLQ-H\&N35 was scored from 0 to 100. Higher scores indicated a worsening QOL.
Time frame: From date of randomization until the end radiotherapy, up to 3 months.
We recruited patients with head and neck cancer receiving radiotherapy in the First Affiliated Hospital of Harbin Medical University between January 2017 and October 2019.
| Milestone | Kanglaite Group |
|---|---|
| Started | 53 |
| Completed | 46 |
| Not completed | 7 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Patient's information was incomplete | 1 |
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.
| Participants | Kanglaite Group |
|---|---|
| Grade 1 mucositis | 3 |
| Grade 2 mucositis | 38 |
| Grade 3 mucositis | 5 |
| Grade 4 mucositis | 0 |
The non-hematologic toxicity side events were assessed by CTCAE v4. The highest grade be recorded. The grade 1 was the best and grade 4 was the worst.
| Participants | Kanglaite Group |
|---|---|
| grade 1 superficial phlebitis | 1 |
| grade 1 rash | 1 |
| radiotherapy dose reduction | 1 |
| irradiation field modification | 0 |
| radiotherapy interruption | 4 |
The grade of hematologic toxicity side events were assessed by CTCAE v4. The highest grade be recorded. The grade 1 was the best and grade 4 was the worst.
| Participants | Kanglaite Group |
|---|---|
| Neutropenia — grade 0 | 30 |
| Neutropenia — grade 1-2 | 13 |
| Neutropenia — grade 3-4 | 3 |
| Anemia — grade 0 | 28 |
| Anemia — grade 1-2 | 18 |
| Anemia — grade 3-4 | 0 |
| Thrombocytopenia — grade 0 | 40 |
| Thrombocytopenia — grade 1-2 | 6 |
| Thrombocytopenia — grade 3-4 | 0 |
| Pre-albumin decrease — grade 0 | 37 |
| Pre-albumin decrease — grade 1-2 | 9 |
| Pre-albumin decrease — grade 3-4 | 0 |
| Albumin decreasing — grade 0 | 44 |
| Albumin decreasing — grade 1-2 | 2 |
| Albumin decreasing — grade 3-4 | 0 |
| alanine transaminase increasing — grade 0 | 41 |
| alanine transaminase increasing — grade 1-2 | 5 |
| alanine transaminase increasing — grade 3-4 | 0 |
| aspartate transaminase increasing — grade 0 | 43 |
| aspartate transaminase increasing — grade 1-2 | 3 |
| aspartate transaminase increasing — grade 3-4 | 0 |
| alkaline phosphatase increasing — grade 0 | 45 |
| alkaline phosphatase increasing — grade 1-2 | 1 |
| alkaline phosphatase increasing — grade 3-4 | 0 |
| total bilirubin increasing — grade 0 | 43 |
| total bilirubin increasing — grade 1-2 | 3 |
| total bilirubin increasing — grade 3-4 | 0 |
| creatinine increasing — grade 0 | 44 |
| creatinine increasing — grade 1-2 | 2 |
| creatinine increasing — grade 3-4 | 0 |
| blood urea nitrogen increasing — grade 0 | 45 |
| blood urea nitrogen increasing — grade 1-2 | 1 |
| blood urea nitrogen increasing — grade 3-4 | 0 |
The nutritional status was assessed by PG-SGA questionnaire.PG-SGA scores were recorded weekly during radiotherapy. A score of 0-1 indicated good nourishment, 2-8 suspected or moderate malnutrition, ≥ 9 risk of severe malnutrition.
| Participants | Kanglaite Group |
|---|---|
| Score 0-1 | 2 |
| Score 2-8 | 13 |
| Score ≧9 | 31 |
The overall quality of life was assessed by EORTC QLQ-C30 questionnaire. QLQ-C30 scores were valued weekly during radiotherapy and post radiotherapy.The worst score of patients was recorded. The QLQ-C30 was scored from 0 to 100. Higher scores for function indicated a better QOL whereas the symptoms indicated a worsening QOL.
| units on a scale | Kanglaite Group |
|---|---|
| global quality of life during radiotherapy | 56.52 ± 29.80 |
| physical functioning during radiotherapy | 77.19 ± 21.66 |
| rolel functioning during radiotherapy | 70.28 ± 27.42 |
| emotional functioning during radiotherapy | 77.35 ± 22.07 |
| cognitive functioning during radiotherapy | 74.99 ± 23.23 |
| social functioning during radiotherapy | 62.68 ± 31.26 |
| fatigue during radiotherapy | 32.32 ± 21.91 |
| nausea and vomiting during radiotherapy | 22.07 ± 24.09 |
| pain during radiotherapy | 34.05 ± 26.73 |
| dyspnoea during radiotherapy | 21.01 ± 28.42 |
| insomnia during radiotherapy | 31.15 ± 31.74 |
| appetite loss during radiotherapy | 43.47 ± 32.10 |
| costipation during radiotherapy | 26.08 ± 28.90 |
| diarrhoea during radiotherapy | 12.31 ± 19.06 |
| global quality of life post radiotherapy | 64.72 ± 24.93 |
| physical functioning post radiotherapy | 81.09 ± 22.00 |
| role functioning post radiotherapy | 75.58 ± 25.02 |
| emotional functioning post radiotherapy | 97.4 ± 10.47 |
| cognitive functioning post radiotherapy | 83.72 ± 20.72 |
| social functioning post radiotherapy | 72.09 ± 27.39 |
| fatigue post radiotherapy | 28.16 ± 23.30 |
| nausea and vomiting post radiotherapy | 11.26 ± 19.08 |
| pain post radiotherapy | 21.70 ± 23.43 |
| dyspnoea post radiotherapy | 19.12 ± 31.82 |
| insomnia post radiotherapy | 21.70 ± 30.67 |
| appetite post radiotherapy | 39.53 ± 30.21 |
| constipation post radiotherapy | 16.27 ± 23.42 |
| diarrhoea post radiotherapy | 4.65 ± 11.68 |
Quality of life specific to head and neck cancers was assessed by EORTC QLQ-H\&N35 questionnaire. QLQ-H\&N35 scores were valued weekly during radiotherapy and post radiotherapy. The highest score of patients was recorded. The QLQ-H\&N35 was scored from 0 to 100. Higher scores indicated a worsening QOL.
| units on a scale | Kanglaite Group |
|---|---|
| pain during radiotherapy | 41.83 ± 23.72 |
| swallowing during radiotherapy | 42.03 ± 27.05 |
| sensory problems during radiotherapy | 35.5 ± 26.89 |
| speech problems during radiotherapy | 43.59 ± 36.51 |
| social eating problems during radiotherapy | 40.57 ± 30.51 |
| social contact problems during radiotherapy | 21.08 ± 25.52 |
| less sexuality during radiotherapy | 41.86 ± 40.67 |
| teeth during radiotherapy | 28.98 ± 34.14 |
| mouth opening problems during radiotherapy | 27.53 ± 28.37 |
| dry mouth during radiotherapy | 60.14 ± 29.49 |
| sticky saliva during radiotherapy | 66.66 ± 26.29 |
| coughing during radiotherapy | 42.75 ± 33.45 |
| feeling ill during radiotherapy | 47.40 ± 27.05 |
| pain post radiotherapy | 33.72 ± 26.11 |
| swallowing post radiotherapy | 36.04 ± 23.40 |
| sensory problems post radiotherapy | 36.04 ± 29.30 |
| speech problems post radiotherapy | 38.49 ± 35.41 |
| social eating problems post radiotherapy | 28.09 ± 24.60 |
| social contact problems post radiotherapy | 11.99 ± 17.03 |
| less sexuality post radiotherapy | 37.96 ± 38.34 |
| teeth post radiotherapy | 23.25 ± 29.57 |
| mouth opening problems post radiotherapy | 12.40 ± 17.85 |
| dry mouth post radiotherapy | 53.48 ± 34.22 |
| sticky saliva post radiotherapy | 56.58 ± 35.28 |
| coughing post radiotherapy | 37.2 ± 33.49 |
| feeling ill post radiotherapy | 37.20 ± 29.28 |
Collected over 2 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Kanglaite Group | 0/46 (0%) | 7/46 (15.2%) | 34/46 (73.9%) |
| Event | Kanglaite Group |
|---|---|
| mucositisSkin and subcutaneous tissue disorders | 5/46 |
| NeutropeniaBlood and lymphatic system disorders | 3/46 |
| Event | Kanglaite Group |
|---|---|
| anemiaBlood and lymphatic system disorders | 18/46 |
| NeutropeniaBlood and lymphatic system disorders | 13/46 |
| Pre-albuminGeneral disorders | 9/46 |
| ThrombocytopeniaBlood and lymphatic system disorders | 6/46 |
| Alanine aminotransferaseHepatobiliary disorders | 5/46 |
| Glutamic oxaloacetic transaminaseHepatobiliary disorders | 3/46 |
| Total bilirubinHepatobiliary disorders | 3/46 |
| Age, Categorical(Participants) | Kanglaite Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 34 |
| >=65 years | 12 |
| Sex: Female, Male(Participants) | Kanglaite Group |
|---|---|
| Female | 7 |
| Male | 39 |
| Race and Ethnicity Not Collected(Participants) | Kanglaite Group |
|---|
| Region of Enrollment(participants) | Kanglaite Group |
|---|---|
| China | 46 |
| Nutritional status(Participants) | Kanglaite Group |
|---|---|
| Severe malnutrition | 9 |
| Suspected or moderate malnutrition | 31 |
| Good nourishment | 6 |
| Quality of life specific to head and neck cancers(units on a scale) | Kanglaite Group |
|---|---|
| pain | 19.22 ± 25.15 |
| swallowing | 16.62 ± 24.08 |
| sensory problems | 9.25 ± 22.34 |
| speech problems | 25.67 ± 29.28 |
| social eating problems | 14.43 ± 25.95 |
| social contact problems | 9.48 ± 19.70 |
| less sexuality | 17.55 ± 30.89 |
| teeth | 24.44 ± 32.09 |
| mouth opening problem | 11.58 ± 24.77 |
| dry mouth | 22.22 ± 26.59 |
| sticky saliva | 30.36 ± 31.64 |
| coughing | 22.22 ± 28.42 |
| feeling ill | 22.22 ± 27.52 |
| Overall quality of life (QOL)(units on a scale) | Kanglaite Group |
|---|---|
| global QOL | 73.18 ± 25.39 |
| physical functioning | 89.99 ± 12.05 |
| role functioning | 82.6 ± 24.33 |
| emotional functioning | 84.48 ± 18.36 |
| cognitive functioning | 81.46 ± 25.92 |
| social functioning | 71.1 ± 30.02 |
| fatigue | 21.40 ± 19.34 |
| nausea and vomiting | 4.07 ± 12.38 |
| pain | 16.3 ± 19.29 |
| dyspnoea | 12.59 ± 22.79 |
| insomnia | 14.07 ± 27.05 |
| appetite loss | 14.81 ± 25.18 |
| constipation | 10.36 ± 21.10 |
| diarrhoea | 8.88 ± 16.51 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The investigators have no other clinical trial about cancer of head and neck
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
First Affiliated Hospital of Harbin Medical University