Trial Outcomes & Findings for Kanglaite Reduce the Toxicity of Radiotherapy of Head and Neck Cancer Phase II Study (NCT NCT03101514)
NCT ID: NCT03101514
Last Updated: 2021-06-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
From date of randomization until the end radiotherapy, up to 3 months.
Results posted on
2021-06-23
Participant Flow
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.
Sixty-two patients were assessed for eligibility. Three patients did not meet the inclusion criteria, and six patients declined to participate.
Participant milestones
| Measure |
Kanglaite Group
All patients received 20 g Kanglaite (200 mL) daily, administered as an intravenous injection for 5 days a week, concurrently with radiotherapy. Kanglaite injection was used before or after radiotherapy. There is no time interval requirement between Kanglaite and radiotherapy.
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Kanglaite Group
All patients received 20 g Kanglaite (200 mL) daily, administered as an intravenous injection for 5 days a week, concurrently with radiotherapy. Kanglaite injection was used before or after radiotherapy. There is no time interval requirement between Kanglaite and radiotherapy.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
patient's information was incomplete
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Kanglaite Group
n=46 Participants
Kanglaite injection was used during radiotherapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=46 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=46 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=46 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=46 Participants
|
|
Region of Enrollment
China
|
46 participants
n=46 Participants
|
|
Nutritional status
Severe malnutrition
|
9 Participants
n=46 Participants
|
|
Nutritional status
Suspected or moderate malnutrition
|
31 Participants
n=46 Participants
|
|
Nutritional status
Good nourishment
|
6 Participants
n=46 Participants
|
|
Quality of life specific to head and neck cancers
pain
|
19.22 units on a scale
STANDARD_DEVIATION 25.15 • n=46 Participants
|
|
Quality of life specific to head and neck cancers
swallowing
|
16.62 units on a scale
STANDARD_DEVIATION 24.08 • n=46 Participants
|
|
Quality of life specific to head and neck cancers
sensory problems
|
9.25 units on a scale
STANDARD_DEVIATION 22.34 • n=46 Participants
|
|
Quality of life specific to head and neck cancers
speech problems
|
25.67 units on a scale
STANDARD_DEVIATION 29.28 • n=46 Participants
|
|
Quality of life specific to head and neck cancers
social eating problems
|
14.43 units on a scale
STANDARD_DEVIATION 25.95 • n=46 Participants
|
|
Quality of life specific to head and neck cancers
social contact problems
|
9.48 units on a scale
STANDARD_DEVIATION 19.70 • n=46 Participants
|
|
Quality of life specific to head and neck cancers
less sexuality
|
17.55 units on a scale
STANDARD_DEVIATION 30.89 • n=46 Participants
|
|
Quality of life specific to head and neck cancers
teeth
|
24.44 units on a scale
STANDARD_DEVIATION 32.09 • n=46 Participants
|
|
Quality of life specific to head and neck cancers
mouth opening problem
|
11.58 units on a scale
STANDARD_DEVIATION 24.77 • n=46 Participants
|
|
Quality of life specific to head and neck cancers
dry mouth
|
22.22 units on a scale
STANDARD_DEVIATION 26.59 • n=46 Participants
|
|
Quality of life specific to head and neck cancers
sticky saliva
|
30.36 units on a scale
STANDARD_DEVIATION 31.64 • n=46 Participants
|
|
Quality of life specific to head and neck cancers
coughing
|
22.22 units on a scale
STANDARD_DEVIATION 28.42 • n=46 Participants
|
|
Quality of life specific to head and neck cancers
feeling ill
|
22.22 units on a scale
STANDARD_DEVIATION 27.52 • n=46 Participants
|
|
Overall quality of life (QOL)
global QOL
|
73.18 units on a scale
STANDARD_DEVIATION 25.39 • n=46 Participants
|
|
Overall quality of life (QOL)
physical functioning
|
89.99 units on a scale
STANDARD_DEVIATION 12.05 • n=46 Participants
|
|
Overall quality of life (QOL)
role functioning
|
82.6 units on a scale
STANDARD_DEVIATION 24.33 • n=46 Participants
|
|
Overall quality of life (QOL)
emotional functioning
|
84.48 units on a scale
STANDARD_DEVIATION 18.36 • n=46 Participants
|
|
Overall quality of life (QOL)
cognitive functioning
|
81.46 units on a scale
STANDARD_DEVIATION 25.92 • n=46 Participants
|
|
Overall quality of life (QOL)
social functioning
|
71.1 units on a scale
STANDARD_DEVIATION 30.02 • n=46 Participants
|
|
Overall quality of life (QOL)
fatigue
|
21.40 units on a scale
STANDARD_DEVIATION 19.34 • n=46 Participants
|
|
Overall quality of life (QOL)
nausea and vomiting
|
4.07 units on a scale
STANDARD_DEVIATION 12.38 • n=46 Participants
|
|
Overall quality of life (QOL)
pain
|
16.3 units on a scale
STANDARD_DEVIATION 19.29 • n=46 Participants
|
|
Overall quality of life (QOL)
dyspnoea
|
12.59 units on a scale
STANDARD_DEVIATION 22.79 • n=46 Participants
|
|
Overall quality of life (QOL)
insomnia
|
14.07 units on a scale
STANDARD_DEVIATION 27.05 • n=46 Participants
|
|
Overall quality of life (QOL)
appetite loss
|
14.81 units on a scale
STANDARD_DEVIATION 25.18 • n=46 Participants
|
|
Overall quality of life (QOL)
constipation
|
10.36 units on a scale
STANDARD_DEVIATION 21.10 • n=46 Participants
|
|
Overall quality of life (QOL)
diarrhoea
|
8.88 units on a scale
STANDARD_DEVIATION 16.51 • n=46 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the end radiotherapy, up to 3 months.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.
Outcome measures
| Measure |
Kanglaite Group
n=46 Participants
Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy.
|
|---|---|
|
the Incidence Rate of Severe Radiation Mucositis
Grade 1 mucositis
|
3 Participants
|
|
the Incidence Rate of Severe Radiation Mucositis
Grade 2 mucositis
|
38 Participants
|
|
the Incidence Rate of Severe Radiation Mucositis
Grade 3 mucositis
|
5 Participants
|
|
the Incidence Rate of Severe Radiation Mucositis
Grade 4 mucositis
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the end radiotherapy, up to 3 months.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.
Outcome measures
| Measure |
Kanglaite Group
n=46 Participants
Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy.
|
|---|---|
|
the Incidence Rate of Non-Hematologic Toxicity Side Events
grade 1 superficial phlebitis
|
1 Participants
|
|
the Incidence Rate of Non-Hematologic Toxicity Side Events
grade 1 rash
|
1 Participants
|
|
the Incidence Rate of Non-Hematologic Toxicity Side Events
radiotherapy dose reduction
|
1 Participants
|
|
the Incidence Rate of Non-Hematologic Toxicity Side Events
irradiation field modification
|
0 Participants
|
|
the Incidence Rate of Non-Hematologic Toxicity Side Events
radiotherapy interruption
|
4 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the end radiotherapy, up to 3 months.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.
Outcome measures
| Measure |
Kanglaite Group
n=46 Participants
Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy.
|
|---|---|
|
the Incidence Rate of Hematologic Toxicity Side Events
aspartate transaminase increasing · grade 3-4
|
0 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Neutropenia · grade 0
|
30 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Neutropenia · grade 1-2
|
13 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Neutropenia · grade 3-4
|
3 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Anemia · grade 0
|
28 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Anemia · grade 1-2
|
18 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Anemia · grade 3-4
|
0 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Thrombocytopenia · grade 0
|
40 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Thrombocytopenia · grade 1-2
|
6 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Thrombocytopenia · grade 3-4
|
0 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Pre-albumin decrease · grade 0
|
37 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Pre-albumin decrease · grade 1-2
|
9 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Pre-albumin decrease · grade 3-4
|
0 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Albumin decreasing · grade 0
|
44 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Albumin decreasing · grade 1-2
|
2 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
Albumin decreasing · grade 3-4
|
0 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
alanine transaminase increasing · grade 0
|
41 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
alanine transaminase increasing · grade 1-2
|
5 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
alanine transaminase increasing · grade 3-4
|
0 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
aspartate transaminase increasing · grade 0
|
43 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
aspartate transaminase increasing · grade 1-2
|
3 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
alkaline phosphatase increasing · grade 0
|
45 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
alkaline phosphatase increasing · grade 1-2
|
1 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
alkaline phosphatase increasing · grade 3-4
|
0 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
total bilirubin increasing · grade 0
|
43 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
total bilirubin increasing · grade 1-2
|
3 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
total bilirubin increasing · grade 3-4
|
0 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
creatinine increasing · grade 0
|
44 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
creatinine increasing · grade 1-2
|
2 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
creatinine increasing · grade 3-4
|
0 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
blood urea nitrogen increasing · grade 0
|
45 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
blood urea nitrogen increasing · grade 1-2
|
1 Participants
|
|
the Incidence Rate of Hematologic Toxicity Side Events
blood urea nitrogen increasing · grade 3-4
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the end radiotherapy, up to 3 months.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.
Outcome measures
| Measure |
Kanglaite Group
n=46 Participants
Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy.
|
|---|---|
|
the Nutritional Status
Score 0-1
|
2 Participants
|
|
the Nutritional Status
Score 2-8
|
13 Participants
|
|
the Nutritional Status
Score ≧9
|
31 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the end radiotherapy, up to 3 months.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.
Outcome measures
| Measure |
Kanglaite Group
n=46 Participants
Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy.
|
|---|---|
|
the Overall Quality of Life (QOL)
global quality of life during radiotherapy
|
56.52 units on a scale
Standard Deviation 29.80
|
|
the Overall Quality of Life (QOL)
physical functioning during radiotherapy
|
77.19 units on a scale
Standard Deviation 21.66
|
|
the Overall Quality of Life (QOL)
rolel functioning during radiotherapy
|
70.28 units on a scale
Standard Deviation 27.42
|
|
the Overall Quality of Life (QOL)
emotional functioning during radiotherapy
|
77.35 units on a scale
Standard Deviation 22.07
|
|
the Overall Quality of Life (QOL)
cognitive functioning during radiotherapy
|
74.99 units on a scale
Standard Deviation 23.23
|
|
the Overall Quality of Life (QOL)
social functioning during radiotherapy
|
62.68 units on a scale
Standard Deviation 31.26
|
|
the Overall Quality of Life (QOL)
fatigue during radiotherapy
|
32.32 units on a scale
Standard Deviation 21.91
|
|
the Overall Quality of Life (QOL)
nausea and vomiting during radiotherapy
|
22.07 units on a scale
Standard Deviation 24.09
|
|
the Overall Quality of Life (QOL)
pain during radiotherapy
|
34.05 units on a scale
Standard Deviation 26.73
|
|
the Overall Quality of Life (QOL)
dyspnoea during radiotherapy
|
21.01 units on a scale
Standard Deviation 28.42
|
|
the Overall Quality of Life (QOL)
insomnia during radiotherapy
|
31.15 units on a scale
Standard Deviation 31.74
|
|
the Overall Quality of Life (QOL)
appetite loss during radiotherapy
|
43.47 units on a scale
Standard Deviation 32.10
|
|
the Overall Quality of Life (QOL)
costipation during radiotherapy
|
26.08 units on a scale
Standard Deviation 28.90
|
|
the Overall Quality of Life (QOL)
diarrhoea during radiotherapy
|
12.31 units on a scale
Standard Deviation 19.06
|
|
the Overall Quality of Life (QOL)
global quality of life post radiotherapy
|
64.72 units on a scale
Standard Deviation 24.93
|
|
the Overall Quality of Life (QOL)
physical functioning post radiotherapy
|
81.09 units on a scale
Standard Deviation 22.00
|
|
the Overall Quality of Life (QOL)
role functioning post radiotherapy
|
75.58 units on a scale
Standard Deviation 25.02
|
|
the Overall Quality of Life (QOL)
emotional functioning post radiotherapy
|
97.4 units on a scale
Standard Deviation 10.47
|
|
the Overall Quality of Life (QOL)
cognitive functioning post radiotherapy
|
83.72 units on a scale
Standard Deviation 20.72
|
|
the Overall Quality of Life (QOL)
social functioning post radiotherapy
|
72.09 units on a scale
Standard Deviation 27.39
|
|
the Overall Quality of Life (QOL)
fatigue post radiotherapy
|
28.16 units on a scale
Standard Deviation 23.30
|
|
the Overall Quality of Life (QOL)
nausea and vomiting post radiotherapy
|
11.26 units on a scale
Standard Deviation 19.08
|
|
the Overall Quality of Life (QOL)
pain post radiotherapy
|
21.70 units on a scale
Standard Deviation 23.43
|
|
the Overall Quality of Life (QOL)
dyspnoea post radiotherapy
|
19.12 units on a scale
Standard Deviation 31.82
|
|
the Overall Quality of Life (QOL)
insomnia post radiotherapy
|
21.70 units on a scale
Standard Deviation 30.67
|
|
the Overall Quality of Life (QOL)
appetite post radiotherapy
|
39.53 units on a scale
Standard Deviation 30.21
|
|
the Overall Quality of Life (QOL)
constipation post radiotherapy
|
16.27 units on a scale
Standard Deviation 23.42
|
|
the Overall Quality of Life (QOL)
diarrhoea post radiotherapy
|
4.65 units on a scale
Standard Deviation 11.68
|
SECONDARY outcome
Timeframe: From date of randomization until the end radiotherapy, up to 3 months.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.
Outcome measures
| Measure |
Kanglaite Group
n=46 Participants
Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy.
|
|---|---|
|
Quality of Life Specific to Head and Neck Cancers
mouth opening problems post radiotherapy
|
12.40 units on a scale
Standard Deviation 17.85
|
|
Quality of Life Specific to Head and Neck Cancers
pain during radiotherapy
|
41.83 units on a scale
Standard Deviation 23.72
|
|
Quality of Life Specific to Head and Neck Cancers
swallowing during radiotherapy
|
42.03 units on a scale
Standard Deviation 27.05
|
|
Quality of Life Specific to Head and Neck Cancers
sensory problems during radiotherapy
|
35.5 units on a scale
Standard Deviation 26.89
|
|
Quality of Life Specific to Head and Neck Cancers
speech problems during radiotherapy
|
43.59 units on a scale
Standard Deviation 36.51
|
|
Quality of Life Specific to Head and Neck Cancers
social eating problems during radiotherapy
|
40.57 units on a scale
Standard Deviation 30.51
|
|
Quality of Life Specific to Head and Neck Cancers
social contact problems during radiotherapy
|
21.08 units on a scale
Standard Deviation 25.52
|
|
Quality of Life Specific to Head and Neck Cancers
less sexuality during radiotherapy
|
41.86 units on a scale
Standard Deviation 40.67
|
|
Quality of Life Specific to Head and Neck Cancers
teeth during radiotherapy
|
28.98 units on a scale
Standard Deviation 34.14
|
|
Quality of Life Specific to Head and Neck Cancers
mouth opening problems during radiotherapy
|
27.53 units on a scale
Standard Deviation 28.37
|
|
Quality of Life Specific to Head and Neck Cancers
dry mouth during radiotherapy
|
60.14 units on a scale
Standard Deviation 29.49
|
|
Quality of Life Specific to Head and Neck Cancers
sticky saliva during radiotherapy
|
66.66 units on a scale
Standard Deviation 26.29
|
|
Quality of Life Specific to Head and Neck Cancers
coughing during radiotherapy
|
42.75 units on a scale
Standard Deviation 33.45
|
|
Quality of Life Specific to Head and Neck Cancers
feeling ill during radiotherapy
|
47.40 units on a scale
Standard Deviation 27.05
|
|
Quality of Life Specific to Head and Neck Cancers
pain post radiotherapy
|
33.72 units on a scale
Standard Deviation 26.11
|
|
Quality of Life Specific to Head and Neck Cancers
swallowing post radiotherapy
|
36.04 units on a scale
Standard Deviation 23.40
|
|
Quality of Life Specific to Head and Neck Cancers
sensory problems post radiotherapy
|
36.04 units on a scale
Standard Deviation 29.30
|
|
Quality of Life Specific to Head and Neck Cancers
speech problems post radiotherapy
|
38.49 units on a scale
Standard Deviation 35.41
|
|
Quality of Life Specific to Head and Neck Cancers
social eating problems post radiotherapy
|
28.09 units on a scale
Standard Deviation 24.60
|
|
Quality of Life Specific to Head and Neck Cancers
social contact problems post radiotherapy
|
11.99 units on a scale
Standard Deviation 17.03
|
|
Quality of Life Specific to Head and Neck Cancers
less sexuality post radiotherapy
|
37.96 units on a scale
Standard Deviation 38.34
|
|
Quality of Life Specific to Head and Neck Cancers
teeth post radiotherapy
|
23.25 units on a scale
Standard Deviation 29.57
|
|
Quality of Life Specific to Head and Neck Cancers
dry mouth post radiotherapy
|
53.48 units on a scale
Standard Deviation 34.22
|
|
Quality of Life Specific to Head and Neck Cancers
sticky saliva post radiotherapy
|
56.58 units on a scale
Standard Deviation 35.28
|
|
Quality of Life Specific to Head and Neck Cancers
coughing post radiotherapy
|
37.2 units on a scale
Standard Deviation 33.49
|
|
Quality of Life Specific to Head and Neck Cancers
feeling ill post radiotherapy
|
37.20 units on a scale
Standard Deviation 29.28
|
Adverse Events
Kanglaite Group
Serious events: 7 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Kanglaite Group
n=46 participants at risk
Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy.
|
|---|---|
|
Skin and subcutaneous tissue disorders
mucositis
|
10.9%
5/46 • 2 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.5%
3/46 • 2 months
|
Other adverse events
| Measure |
Kanglaite Group
n=46 participants at risk
Kanglaite 200ml is injected once a day from Monday to Friday during radiotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
39.1%
18/46 • 2 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.3%
13/46 • 2 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.0%
6/46 • 2 months
|
|
General disorders
Pre-albumin
|
19.6%
9/46 • 2 months
|
|
Hepatobiliary disorders
Alanine aminotransferase
|
10.9%
5/46 • 2 months
|
|
Hepatobiliary disorders
Glutamic oxaloacetic transaminase
|
6.5%
3/46 • 2 months
|
|
Hepatobiliary disorders
Total bilirubin
|
6.5%
3/46 • 2 months
|
Additional Information
Dr. Zhi-Ping Liu
the first affiliated hospital of Harbin medical university
Phone: +8613936034546
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place