Testing the Effectiveness of Henna on Managing PPE

Cyprus University of Technology

Status: Completed

Conditions: Palmar-plantar Erythrodysesthesia (PPE)

Treatments: Drug: Henna; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01751893

AC-PPEHP-88

Details and patient eligibility

About

The palmar-plantar erythrodysesthesia (PPE) is the only clinical adverse event that commonly occurs with capecitabine and/or pegylated liposomal doxorubicin treatment and it warrants special attention because it is the most common dose-limiting toxicity. this study is designed to test the effectiveness of a henna treatment protocol in the management of capecitabine and/or pegylated liposomal doxorubicin induced palmar-plantar erythrodysesthesia.

Full description

This will be a randomized double-blind, placebo-controlled study with 80 cancer patients that will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin. The selection of potential participants will be based on pre-determined inclusion and exclusion criteria. Patients will be randomly allocated either to the treatment group or the placebo group. Treatment will be delivered twice a week and assessments will take place at 2, 3, 4, 5 and 6 weeks.

The intervention group will receive the application of henna to the hands and/or feet of the patients and the control group will receive the placebo.

At both baseline and follow-up, patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia, the Quality of Life, the need for dose-limiting due to PPE and Pain intensity using standardized rating scales. Data will be analysed with inferential and descriptive statistics.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult cancer patients (>18)
• Patients receiving capecitabine and/or PLD as monotherapy or in combination with other agents
• Patients that will experience PPE grade 1 or above
• Willing to participate
• Ability to complete the psychometric assessments.
• A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG)

Exclusion criteria

• Patients with hypersensitivity to natural henna.
• Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results
• Patients on Pyridoxine or nicotine patches
• Patients with a previous history of PPE
• Patients whose chemotherapy was discontinued for more than a week

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

56 participants in 2 patient groups, including a placebo group

Henna arm

Experimental group

Description:

Based on the treatment protocol for this study the patients will receive the henna treatment for 4 weeks (supervised treatment for first week and then unsupervised sessions twice a week). The treatment will include the application of the henna mixture (paste) (40gr natural henna and 40ml of purified water) to the affected areas (feet or/and hands) and wear socks or/and gloves. The treatment session will last for 1 hour and then the mixture will be rinsed with fresh water.

Treatment:

Drug: Henna

Placebo

Placebo Comparator group

Description:

Based on the treatment protocol for this study the patients in this arm will receive the henna placebo treatment for 4 weeks (supervised treatment for first week and then unsupervised sessions twice a week). The treatment will include the application of the henna placebo mixture (paste) (40gr placebo henna and 40ml of purified water) to the affected areas (feet or/and hands) and wear socks or/and gloves. The treatment session will last for 1 hours and then the mixture will be rinsed with fresh water.

Treatment:

Drug: Placebo