Study for safety and efficacy of Amitose-DGA containing cream in the patients recieving sunitinib therapy

JRCT ID: jRCTs051180051

Registered date:07/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Renal cell carcinoma patinents
• Date of first enrollment: 21/11/2017
• Target sample size: 30
• Study type: Interventional
• Intervention(s): The participants apply 3 finger-tip units Amitose DGA-containing cream all over both palmar and plantar surfaces more than 3 times a day, within 2 treatment cycles (6 weeks) of sunitinib. They also apply heparinoid or urea-containing cream as a standard preventive treatment for HFSR following application of the investigational cream. The participants were instructed to apply the investigational cream to moist skin, such as when washing their hands or feet, during face-washing, or after bathing. The participants keep a personal diary to record frequency of Amitose DGA-containing cream.

Outcome(s)

Primary Outcome

Phase I:
Cutaneous abnormality in palmar or plantar such as bullous dermatitis, dry skin, erythroderma, pruritus, purpura, rash maculopapular, skin hyperpigmentation, and skin hypopigmentation within two cycles (6 weeks) of sunitinib therapy.

Phase II:
Development of grade 1 or higher of hand-foot skin reaction* within 6 weeks of sunitinib therapy.
*hand-foot skin reaction is identified Palmar-plantar erythrodysesthesia syndrome described in Common Terminology Criteria for Adverse Events by National Cancer Institute

Secondary Outcome

Phase I:
Abnormality of hematological test within observation period

Phase II:
Development of grade 2 or higher of hand-foot skin reaction within 6 weeks of sunitinib therapy.
Progression free survival and time to treatment failure of sunitinib therapy.
Cutaneous abnormality in palmar or plantar such as bullous dermatitis, dry skin, erythroderma, pruritus, purpura, rash maculopapular, skin hyperpigmentation, and skin hypopigmentation within observation period.
Development of grade 2 or higher of hand-foot skin reaction within 3 weeks after completion of investigational treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Providing informed consent
2) Aged 20 years or older
3) Histologically-diagnosed RCC
4) Receiving sunitinib therapy, with or without prior target therapy and before or after nephrectomy.
5) Eastern Cooperative Oncology Group Performance Status of 0-2
6) Expected to survive for more than 12 weeks at screening.
7) Exhibit higher compliance for applying the investigational cream, attending clinical visits, undergoing laboratory tests, and keeping a personal dairy based on the study protocol.

Exclude criteria

1) Patients with dermatological abnormalities of the palmar or plantar surfaces
2) Patients who used topical medications on the palmar or plantar surfaces (except for heparinoid or urea-containing cream)
3) Patients who were unable to apply the heparinoid or urea-containing cream to the palmar or plantar surfaces
4) Grade 1 or higher hand-foot skin reaction based on Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.0 at the start of sunitinib therapy
5) Patients with active infections requiring treatment
6) Severe liver injury (alanine aminotransferase (ALT) >= 5-fold upper limit of normal or 2-fold individual baseline value)
7) Severe kidney injury (serum creatinine level >= 2-fold individual baseline value)
8) Other patients who were determined to be inappropriate for study participation by the primary investigator

Related Information

• Primary Sponsor: Kunisada Makoto
• Source(s) of Monetary Support: Momotani Juntenkan Ltd.
• Secondary ID(s): UMIN000027209