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Clinical Studies - Hand to Heal

 

Effect of Chinese Herbal Formula JDXZO Cream on patients with Chemotherapy-induced hand-foot syndrome

Hongsheng Lin, Jie Li, Wei Hou Ying Zhang

Oncology Department of Guang'anmen Hospital, China Academy of Chinese Medical Sciences

This abstract was selected for oral presentation at the 12th International Conference of the Society for Integrative Oncology (SIO) November 14-16, 2015 in Boston, MA, USA. The formulation of CamWell™ Hand to Heal™ botanical cream is the same as JDXZO cream listed in this abstract.

 

BACKGROUND: Hand-foot syndrome (HFS), also known as palmar- plantar erythrodysesthesia, is a skin reaction that appears on the palms of hands and/or soles of feet after using certain chemotherapy drugs, including capecitabine, sorafenib, and gefitinib. Most cases are associated with fluorouracil, liposomal doxorubicin, or capecitabine. The incidence of HFS is approximately 7.3%-63%. Effective methods to prevent and cure HFS have not been established and HFS negatively influences patient quality of life (QOL) in a significant way. In this study, Traditional Chinese Herbal Formula JDXZO cream was examined for its effect on treating and relieving the symptoms of HFS and improving QOL of patients.

METHODS: Patients were assigned randomly to Group A or B. Group A was given Traditional Chinese Herbal Formula JDXZO Cream to gently apply to affected areas twice daily. Group B was given placebo cream to apply to affected areas twice daily as well. After a 2-week treatment, the therapeutic effect was assessed by observing three major symptoms, including pain, ulceration, and muscular atrophy. This was assessed with the HFS-14 questionnaire.

RESULTS: Significant differences were observed between the two groups in pain relief, and improvement of daily life, walking, and interpersonal communication (P<0.01). No significant differences in driving ability or interpersonal relationships were found. After 2 weeks, the effective rate was 81.96% in Group A, which was significantly higher than the 33% in Group B (P=0.00).

 

Table 1 HFS Grading

Grade

Clinical symptom

Functional

1

Numbness,   tingling, painless erythema, and swelling

Discomfort   that does not disrupt normal activities

2

Painful   erythema and swelling

Discomfort   that affects activities of daily life

3

Moist   desquamation, ulceration, blisters, and sever pain

Severe   discomfort, inability to work or perform activities of daily living

Note: the National Cancer Institute classification is adopted for Hand-foot syndrome grading. HFS: hand-foot syndrome.

 

Table 2 Evaluation of Effect

Effect

Definition

Recovery

The disappearance of pain,   ulceration and muscular atrophy, etc., the patients recover to normal daily   life.

Effective

There is obvious alleviation of   pain, ulceration and muscular atrophy, etc., but the patients can still feel   some unfitness such as numbness.

Ineffective

There is no obvious alleviation of   hand-foot syndrome symptoms and the patients has serious unfitness condition,   which badly influences the patients' daily work and life

Worse

The hand-foot syndrome symptoms get   worse, and the chemotherapy and biological target therapy have to be stopped.

 

Tabel 3: Comparison of Effect Between Group A & B

Group       Recovery   Effective    Ineffective    Worse   Effectived Rate(%)        

Group A        37              13                8                 3                82

Group B         9               10               21               17               33

 

Notes: Group A used the Traditional Chinese Herbal Formula JDXZO cream; Group B received placebo cream.

 

 

Figure 1: Evaluation of effect after a 2-week treatment Group A was given the Traditional Chinese Herbal Formula JDXZO cream and Group B was given a placebo cream.

 

Table 4 Effect Evaluated with HFS-14 for Group A

Items

Before treatment

1W

2W

3W

P value

Pain

Difficulty in closing the door

Difficulty in preparing meals

Difficulty in daily actions

Difficulty in washing face and brushing teeth

Not able to drive the car

Difficulty in putting on socks or gloves

Difficulty in getting dressed

Difficulty in putting on shoes

Difficulty in standing

Difficulty in walking, even a short distance

Staying seated or lying down

Difficulty in falling asleep

Feeling suffering in work

No good relation with others

5

69

75

89

75

89

62

93

65

55

67

99

75

81

33

2

43

45

49

51

45

43

51

32

25

33

74

55

35

31

2

17

27

28

19

22

23

33

15

15

21

31

22

11

23

1

0

13

11

16

10

0

19

0

0

15

21

138

15

21

<0.01

<0.01

<0.01

<0.01

<0.01

NS

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

<0.01

NS

Notes: a higher score indicates poorer quality of life. NS: not significant; HFS: hand-foot syndrome

 

CONCLUSION: Chinese Herb Formula JDXZO Cream is effective in the treatment of HFS. It is shown to improve quality of life according to the HFS-14.

 

________________________________________________________________________________ 

 

Randomized, Double blind, Placebo Controlled Clinical Study
of Chinese Herbal Formula JDXZO Cream
to Reduce Hand-Foot Syndrome Associated with Capecitabine Chemotherapy

This is a reprint of abstract #35 of the Eighth International Conference of Society for Integrative Oncology (SIO) - November 2011, Cleveland, Ohio.


Hongsheng Lin, China Academy of Chinese Medicines; Jie Li, China Academy of Chinese Medicines; Wei Hou, China Academy of Chinese Medicines


Purpose: Hand-Foot Syndrome (HFS) is a common side effect of several chemotherapies such as 5-FU and its derivatives. Literature shows 45-68% cancer patients receiving oral capecitabine treatment developed HFS; 34% of them had severe HFS to a point where doctors had to reduce their chemotherapy dose or temporarily stop chemotherapy. Chinese herbal medicine JDXZF (including herba dictamni cortex, etc.) is an empirical formula. The preliminary study has shown JDXZF is effective for relieving pain and helpful for the skin lesion on treating HFS. JDXZO is an advanced Chinese herbal extract cream based on JDXZF for easy use. No side effect such as allergy or infection related to JDXZO was found. This randomized, double blind, placebo-controlled study aims to evaluate the safety and efficacy of JDXZO for HFS.


Methods: Cancer patients with HFS grade >= 1 (NCI-CTCAE version 3.0) caused by capecitabine were eligible. Patients received oral capecitabine twice daily on days 1-14. Capecitabine chemotherapy was repeated every 21 days in the absence of disease progression or unacceptable toxicity. Patients with same HFS grade level were randomized to cream A or cream B arm and instructed to gently apply cream on affected areas twice daily for two weeks. Patients’ HFS grades were assessed before and after treatment.

Evaluation criteria: CR as symptoms disappear completely, PR as grade decreases more than one level, PD as symptoms or grade increase, total response rate as CR + PR. Time relative to HFS grade level decrease was counted in days.


Results: 31 cancer patients entered and received 2-6 courses of capecitabine. The medium time-to-develop HFS was week 2 of capecitabine chemotherapy. A total of 83 HFS cases (if the same patients developed HFS multiple times during chemotherapy they were counted separately) were evaluated and 39 were grade 1, 34 were grade 2 and 10 were grade 3. HFS cases in cream A or B arm were 42 and 41, respectively. There was no statistical difference between the two arms in gender, age and cancer type (P>0.05).

Cream A arm CR was 11.9% (5/42), PR was 28.6% (12/42), PD was 59.5% (25/42), total response rate was 40.5%. CR of cream B arm was 36.6% (15/41), PR was 46.3% (19/41), PD was 19.5% (8/41), and total response rate was 82.9%. Improvement of skin lesion toxicity mainly included relief of numbness, dermatitis, desquamation and ulceration pain on the palms or soles. The average treatment time for grade level decrease in cream B arm was 1.7 days shorter than that of cream A arm, it was 2.9 days shorter in grade 3 patients(P

Conclusion: JDXZO was superior to placebo in improving HFS. Cream A and Cream B were provided by Unitech Medical®

 


 

Society for Integrative Oncology (SIO) 2012, Abstract #8

Title: Randomized, Double blind, Placebo Controlled Clinical Study of Chinese Herbal Formula JDXZO Cream to Reduce Skin lesion Associated with EGFRIs Therapy

Hongsheng Lin1, Changhuai Chen2, Qian Dong 1

Keywords: epidermal growth factor receptor inhibitor (EGFRI), skin lesion, herbal formula, cream

Purpose: Skin lesion associated with epidermal growth factor receptor inhibitor (EGFRI) therapy is a common side effect. It is generally considered mild to moderate and affects more than 50% of patients receiving treatment showed in literatures. The incidence of severe rash (grade 3) is reported in up to 16% to 18% of patients. If patients have severe skin lesion that doctors had to reduce their dose or stop EFGRI therapy. Chinese herbal medicine JDXZF is an empirical formula. JDXZO is an advanced Chinese herbal extract cream based on JDXZF for easy use. The previous study has shown JDXZO is effective for the skin lesion on treating HFS caused by 5-Fu and its derivatives and has no side effect. This randomized, double blind, placebo-controlled study is to evaluate the safety and efficacy of JDXZO for skin lesion caused by EGFRIs.

Methods: Cancer patients with skin toxicity grade >= 1 (NCI-CTCAE version 3.0) caused by EGFRIs were eligible. Patients with same skin toxicity grade level were randomized to cream A or cream B arm and instructed to gently apply cream on affected areas twice daily for four weeks. Patients were assessed on baseline and on treatment of two and four weeks. Evaluation criteria: CR as symptoms disappear completely, PR as grade decreases more than one level, NR as symptoms or grade has no change or increase, total response rate as CR + PR. Time to grade level decrease was counted in days for each symptoms.

Results: 59 cases in effect were evaluated. Patients in cream A or B arm were 31 and 28. All of these patients have skin rash and itching, part of them have desquamation, cracking and pigmentation. Only a few patients have paronychia and pain. There was no statistical difference between the two arms in gender, age, types of drug and grad of skin lesion (P>0.05). In cream A arm, the total response rate of skin rash was 70.96% on treatment of two weeks and 80.65% of four weeks, and those of cream B arm were 28.57%(P<0.001) and 35.71%(P<0.001), respectively. The total response rate of itching in cream A arm was 74.19% on treatment of two weeks and 87.10% of four weeks, better than those of cream B arm which were 39.29% (P<0.05) and 46.43%(P<0.001). The total response of desquamation of week 2 is 75% in arm A and 44% in arm B (P>0.05), while on week four, it was 89.29% in arm A, better than that of arm B 48% (P<0.05). Symptoms of pigmentation and cracking were all improved in the two arms but had no significance between them although the total response in cream A arm seems higher. There were 3 cases of paronychia and 5 cases with pain appeared in cream A arm and were all relieved during therapy. 2 cases of paronychia and 3 case of pain in cream B arm had not been relieved. The average treatment time for grade level decrease of each symptom in cream A arm was much shorter (P<0.001) than that of cream B arm, especially among symptoms of itching, desquamation and rash with the average time of 4.97, 5.21 and 6.39 days. After the experiment ended, the data was analyzed and unblinded. Cream A was JDXZO and Cream B was placebo. There was no side effect found in both arms.

Conclusion: JDXZO was superior to placebo in improving skin lesion caused by EGFRIs. Cream A and Cream B were provided by Unitech Medical® in this study.

Footnotes: This abstract was selected for oral presentation at the Ninth International Conference of the Society for Integrative Oncology in October 2012. The formulation of CamWell™ Hand to Heal™ cream is the same as Cream B above in this randomized, double blind, placebo controlled clinical study. 1. Dept of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China. 2. Puxiang TCM Cancer Hospital, Beijing, China.

 

 



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