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NCT01626781 Clinical Trial

A Randomized, Open-label Phase III Trial of Mapisal® Versus an Urea Hand-foot Cream as Prophylaxis for Capecitabine-induced Hand-foot Syndrome in Patients With Gastrointestinal Tumors or Breast Cancer

the Treatment Hand-foot Syndrome Patients With Gastrointestinal Tumors or Breast Cancer, Who Are Treated With Capecitabine Clinical Trial

— PROCAPP  

Official title:
A Randomized, Open-label Phase III Trial of Mapisal® Versus an Urea Hand-foot Cream as Prophylaxis for Capecitabine-induced Hand-foot Syndrome in Patients With Gastrointestinal Tumors or Breast Cancer

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT01626781
Other study ID # AIO-LQ-0111
Secondary ID
Status No longer available
Phase N/A
First received June 21, 2012
Last updated October 21, 2013

Study information
Verified date October 2013
Source AIO-Studien-gGmbH
Contact n/a
Is FDA regulated No
Health authority Germany: German Institute of Medical Documentation and InformationGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
Study type Expanded Access

Clinical Trial Summary

The purpose of this study is the examination of Mapisal® versus urea hand-foot cream as prophylaxis for capecitabine-induced hand-foot syndrome (HFS) in patients with gastrointestinal tumors or breast cancer, to assess the efficacy of Mapisal®.

Mapisal® is a medical device that is approved for the prophylaxis and treatment of HFS. Initial clinical data and case studies on the treatment and prophylaxis of Caelyx-induced HFS have been impressive. Because the pathomechanism of HFS caused by capecitabine is the same as for Caelyx-induced HFS, it is expected reason that administering Mapisal® should result in a significant reduction of HFS caused by capecitabine. The urea hand-foot cream was selected for the standard arm, because it is used commonly, is accepted by patients, and seems to have a positive influence on the severity of the HFS in the experience of many oncologists.

Description:

Hand-foot syndrome (HFS) is a frequently occurring, often dose limiting, dermatologic reaction associated with cytotoxic agents, such as capecitabine, liposomal doxorubicin, and doxetacel.

Adverse events affecting the integument have posed significant challenges to oncologists in recent years in terms of selecting appropriate supportive therapies. Not only medications that inhibit EGFR receptors such as erlotinib, gefitinib, panitumumab or cetuximab, but also multiple-receptor tyrosine kinase inhibitors such as sunitinib and sorafenib and other "older" medications such as capecitabine can often lead to skin-related adverse events that can be difficult to manage.

These adverse events compromise skin-related quality of life and can lead to dose compromises or even the termination of treatment.

To date, there are no side effects reported for the use of either Mapisal® or urea hand-foot cream, making both treatments safe. Given the potential benefits of the treatments in preventing HFS by reducing discomfort and impairment of quality of life, the conduct of the trial is regarded as justifiable and there is no indication that patients are exposed to an increased risk associated with study participation.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Signed written informed consent

2. Male or female =18 years of age

3. Patients with gastrointestinal tumors or breast cancer who will be treated with capecitabine according to label

4. Palliative or adjuvant chemotherapy with capecitabine (combination- or mono-therapy, minimal dose of capecitabine 2000 mg/m2)

5. Life expectancy of least 12 weeks

6. WHO performance status 0-2

7. Adequate contraception

8. Willingness to fill in QoL forms

9. Laboratory requirements

- Platelet count =100 × 109/L

- Leukocyte count > 3.0 × 109/L

- Hemoglobin = 10.0 g/dL

10. Resolution of all chemotherapy- or radiotherapy-related toxicities to grade 1 or lower except for stable sensory neuropathy < grade 2. Any dermatological toxicities other than alopecia resulting from previous chemotherapy or radiotherapy must be completely resolved.

Exclusion Criteria:

1. Previous chemotherapy with capecitabine or liposomal doxorubicine, or any other substance, i.e. tyrosine kinase inhibitors (such as sorafenib and sunitinib) that may induce HFS

2. Radiotherapy or surgery within 4 weeks before start of treatment.

3. Dermatologic diseases that could interfere with the result of the clinical trial

4. Known drug/ alcohol abuse

5. Pregnant or breast feeding patients

6. Participation in another clinical trial and patient received investigational drug within the last 30 days prior to treatment start (i.e. follow-up within a preceding trial is not exclusionary)

7. Known allergic reactions to any of the ingredients of the ointments or capecitabine

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Device:
• Mapisal
Mapisal® ointment will be applied to hand and feet three times daily, as well as after washing hands. Treatment should start 2 days prior to the first chemotherapy cycle with capecitabine and will continue daily for the first 6 weeks of chemotherapy.
Other:
• Urea hand-foot cream
Urea hand-foot cream will be applied to hand and feet three times daily, as well as after washing hands. Treatment should start 2 days prior to the first chemotherapy cycle with capecitabine and will continue daily for the first 6 weeks of chemotherapy.

Locations
Country Name City State
Germany Universitätsmedizin Mannheim, III. Medizinische Klinik Mannheim

Sponsors (1)
Lead Sponsor Collaborator
AIO-Studien-gGmbH

Country where clinical trial is conducted

Germany, 

External Links