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An open, prospective, randomized, multicenter controlled trial for external use Chinese medicine in the treatment of apatinib caused hand and foot skin reaction

An open, prospective, randomized, multicenter controlled trial for external use Chinese medicine in the treatment of apatinib caused hand and foot skin reaction

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016914
Enrollment
Unknown
Registered
2018-07-03
Start date
2018-07-09
Completion date
Unknown
Last updated
2018-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand and foot skin reaction

Interventions

experimental group:Apatinib+external Chinese medicine+hand and foot skin reaction routine therapy
control group:Apatinib+hand and foot skin reaction routine therapy

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years male and female; 2. Patients with Grade 1 or greater hand-foot skin reactions (according to NCI-CTC 4.0 criteria) after receiving apatinib monotherapy; 3. Karnofsky performance status (KPS)>70; 4. No serious heart, liver, kidney and other visceral function dysfunction; 5. Life expectancy more than 3 months; 6. For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrollment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug; 7. Subjects volunteered to join the study and signed the informed consent. Willing to and ability to comply with scheduled visits,treatment plans, laboratory tests, and other study procedure.

Exclusion criteria

Exclusion criteria: 1. Patients with hand-foot skin lesions or history of drug contact allergy before apatinib treatment; 2. Patients were receiving chemotherapeutic or nonchemotherapy drugs which may cause neurotoxicity; 3. Patients have symptoms of nerve compression due to brain metastases or limb metastases, or diseases of the nervous system caused by electrolyte disturbances and other systemic diseases(severe diabetes); 4. Patients have received hormones, Vitamin B and other therapy; 5. The infections or metabolic diseases were uncontrolled; 6. Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk of Clinical research and determination of results.

Design outcomes

Primary

MeasureTime frame
the response for 1 month;

Secondary

MeasureTime frame
Quality of life score;progression-free survival;

Countries

China

Contacts

Public ContactJie-Er Ying

Zhejiang Cancer Hospital

jieerying@aliyun.com+86 13858195803

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026