Clinical trial NCT01751893: Testing the Effectiveness of Henna on Managing PPE
Official title: A Randomized Double-blind, Placebo-controlled Study of the Effects of Lawsonia Inermis on Palmar-Plantar Erythrodysesthesia Induced by Capecitabine and/or Pegylated Liposomal Doxorubicin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palmar-plantar Erythrodysesthesia (PPE)
Keywords: Hand-foot syndrome
palmar-plantar erythrodysesthesia
capecitabine
pegylated liposomal doxorubicin
henna
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
First posted: 2012-12-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline PPE Grade at 3,4, 5,6 weeks
timeFrame: 3, 4, 5 and 6 weeks
Secondary outcomes:
measure: Change from Baseline EORTC QOLc30 at 3,4, 5,6 weeks
timeFrame: 3, 4,5 and 6 weeks
measure: Change from Baseline Hand-foot syndrome 14 (HFS-14) at 3,4,5,6 weeks
timeFrame: 3, 4, 5 and 6 weeks
Other outcomes:
measure: Change from Baseline Activities of daily living at 3,4,5,6 weeks
timeFrame: 3, 4, 5 and 6 weeks
measure: Treatment side-effects
timeFrame: During the 4 weeks
Locations:
city: Nicosia
country: Cyprus
facility: American Medical Centre
Study officials:
References:
citation: Stavrinou M, Tsitsi T, Astras G, Paikousis L, Charalambous A. A randomised controlled feasibility trial to evaluate Lawsonia inermis (henna)'s effect on palmar-plantar erythrodysesthesia induced by capecitabine or pegylated liposomal doxorubicin. Eur J Oncol Nurs. 2021 Apr;51:101908. doi: 10.1016/j.ejon.2021.101908. Epub 2021 Feb 15.