Conference of the Society for Integrative Oncology (SIO) 2015, Abstract #55

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 12^th 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

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.