Effectiveness of the Henna Application in Patients with Hand-Foot Syndrome: Nested Case-Control Study

NCT06832501 | Completed DMC

• 1 other identifier: KA-180085
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: There is an explanation that there is a connection between the application of henna and the occurrence of hand-foot syndrome, and the purpose and progression of this interaction. This nested case-control study of participants who underwent capecitabine therapy were breast and colorectal cancer was carried out to prospectively investigate the relationship of hand-foot syndrome with the henna application. Method: Nested Case-Control (NCC) design within a longitudinal observational prospective cohort study in the setting of an oncology clinic. The primary outcome was hand-foot syndrome from in-hospital interviews and medical record reviews. In the data collection process, 84 patients received capecitabine and two patients (1:2) who met the inclusion criteria served as the control group (n=56, who received the test) for each case (n=28). The case and control groups were followed for 12 weeks. HFS-14 Scale and EORTC QLQ-C30 Quality of Life were conducted on the baseline, first follow-up (T1=day 21), and second follow-up (T2=day 63) cycles of chemotherapy. We used a non-parametric signed-rank test to test the median of paired differences.

Conditions

Henna; Hand-Foot Syndrome; Case-Control Study

Keywords

Capecitabine; palmar-plantar erythrodysesthesia; symptom management; hand-foot syndrome

Outcome Measures

Primary Outcomes (1)

• Effect of Interventions on Outcomes in the HFS Scores

  Hand and foot symptoms scores were measured at the Baseline (T0), T1, and T2.

  From enrollment to the end of treatment at 63 days

Secondary Outcomes (1)

• Effect of Interventions on Outcomes in the EORTC QLQ-C30 Scores

  From enrollment to the end of treatment at 63 days

Study Arms (1)

Case group/Control group

In the data collection process, 84 patients received capecitabine and two patients (1:2) who met the inclusion criteria served as the control group (n=56, who received the test) for each case (n=28).

Other: Henna

Interventions

Henna OTHER

The day-care unit of the University of Hacettepe's oncology hospital is being trained by educational nurses on the treatment of patients receiving capecitabine a day before the application of chemotherapy. All the patients were questioned about their individual and disease-related characteristics using the Patient Information Form, and The National Cancer Institute common terminology criteria for adverse events - version 4.03 (NCICTCAE v4.03), EORTC C30 Cancer Quality of Life Scale, and The Hand-Foot Syndrome-14 (HFS-14) were used by face-to-face interview technique.On the 21st day and the 63rd day after the first treatment course, patients who developed hand-foot syndrome constituted the case-control group, including patients who applied henna and patients who did not apply henna.

Also known as: case group

Case group/Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In the data collection process, 28 patients received capecitabine treatment at the Hacettepe University Hospital of Oncology meeting the research criteria and two patients (n=56, who received the test) who met the inclusion criteria served as the control group for each case. (1:2). Controls were matched with patients in a ratio of two to one depending on age at collection of samples (+3), gender, body surface area index, and skin type data. Minimum number of samples achieved under at least 5% type error and at least 95% power condition. The study used the initial non-development of EAS as a criterion for the HFS scale score, which was studied between "grade 0" and "grade 3" according to the NIC-CTCAE criteria, and was between 18 and 65 years of age.

You may qualify if:

• Would be getting capecitabine as chemotherapy,
• Were aged between 18 and 65,
• Had a diagnosis of either breast or cancer of the colorectal
• Were willing to communicate, literate, and were informed about their diagnosis,
• Were not using psychotropic drugs, anxiolytic, antidepressant, analgesic, or sedative medications,
• Did not have any type of neurological condition or neuropathy, and vi. consented to participate in the study voluntarily.

You may not qualify if:

• Were undergoing radiation,
• Were taking supplements such as vitamin E,
• Had previously had capecitabine treatment,
• Had damage to the skin on their hands or feet,
• Were unwilling to voluntarily engage in the trial.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Adnan Saygun, 06100, Turkey (Türkiye)

Location

Related Publications (16)

• Ngo LH, Inouye SK, Jones RN, Travison TG, Libermann TA, Dillon ST, Kuchel GA, Vasunilashorn SM, Alsop DC, Marcantonio ER. Methodologic considerations in the design and analysis of nested case-control studies: association between cytokines and postoperative delirium. BMC Med Res Methodol. 2017 Jun 6;17(1):88. doi: 10.1186/s12874-017-0359-8.

  PMID: 28587598 BACKGROUND

• Yucel I, Guzin G. Topical henna for capecitabine induced hand-foot syndrome. Invest New Drugs. 2008 Apr;26(2):189-92. doi: 10.1007/s10637-007-9082-3. Epub 2007 Sep 21.

  PMID: 17885735 BACKGROUND

• Ilyas S, Wasif K, Saif MW. Topical henna ameliorated capecitabine-induced hand-foot syndrome. Cutan Ocul Toxicol. 2014 Sep;33(3):253-5. doi: 10.3109/15569527.2013.832280. Epub 2013 Sep 11.

  PMID: 24021017 BACKGROUND

• Habbal O, Hasson SS, El-Hag AH, Al-Mahrooqi Z, Al-Hashmi N, Al-Bimani Z, Al-Balushi MS, Al-Jabri AA. Antibacterial activity of Lawsonia inermis Linn (Henna) against Pseudomonas aeruginosa. Asian Pac J Trop Biomed. 2011 Jun;1(3):173-6. doi: 10.1016/S2221-1691(11)60021-X.

  PMID: 23569753 BACKGROUND

• Hekmatpou D, Ahmadian F, Eghbali M, Farsaei S. Henna ( Lawsonia inermis) as an Inexpensive Method to Prevent Decubitus Ulcers in Critical Care Units: A Randomized Clinical Trial. J Evid Based Integr Med. 2018 Jan-Dec;23:2515690X18772807. doi: 10.1177/2515690X18772807.

  PMID: 29756474 BACKGROUND

• A. Y. Kilcar, B. Cekic, F. Z. B. Muftuler, et al. ''In vitro evaluation of radiolabeled (125 I) methanol extracts of yarrow in cell lines of MCF-7, PC-3, A-549 and Caco-2,'' Journal of Radioanalytical and Nuclear Chemistry 295, no. 1 (2013): 593-599.

  BACKGROUND

• Hadisi Z, Nourmohammadi J, Nassiri SM. The antibacterial and anti-inflammatory investigation of Lawsonia Inermis-gelatin-starch nano-fibrous dressing in burn wound. Int J Biol Macromol. 2018 Feb;107(Pt B):2008-2019. doi: 10.1016/j.ijbiomac.2017.10.061. Epub 2017 Oct 13.

  PMID: 29037870 BACKGROUND

• M. A. Saadabi, ''Evaluation of Lawsonia inermis Linn.(Sudanese henna) leaf extracts as an antimicrobial agent,'' Research Journal of Biological Sciences 2, no. 4 (2007): 419-423.

  BACKGROUND

• H. K. M. Hosein, D. Zinab, ''Phenolic compounds and antioxidant activity of henna leaf extracts (Lawsonia inermis),'' World Journal of Dairy & Food Sciences 2, no. 1 (2007): 38-41.

  BACKGROUND

• E. Karimi, B. Gharib, N. Rostami, L. Navidpour, and M. Afshar, ''Clinical efficacy of a topical polyherbal formulation in the management of fluorouracil-associated hand-foot syndrome,'' Journal of Herbal Medicine 17, (2019): 100270.

  BACKGROUND

• Pandy JGP, Franco PIG, Li RK. Prophylactic strategies for hand-foot syndrome/skin reaction associated with systemic cancer treatment: a meta-analysis of randomized controlled trials. Support Care Cancer. 2022 Nov;30(11):8655-8666. doi: 10.1007/s00520-022-07175-3. Epub 2022 Jun 2.

  PMID: 35655045 BACKGROUND

• Jiang Z, Yang Y, Li L, Yue Z, Lan L, Pan Z. Capecitabine monotherapy in advanced breast cancer resistant to anthracycline and taxane: A meta-analysis. J Cancer Res Ther. 2018 Dec;14(Supplement):S957-S963. doi: 10.4103/0973-1482.187384.

  PMID: 30539829 BACKGROUND

• Scontre VA, Martins JC, de Melo Sette CV, Mutti H, Cubero D, Fonseca F, Del Giglio A. Curcuma longa (Turmeric) for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Pilot Study. J Diet Suppl. 2018 Sep 3;15(5):606-612. doi: 10.1080/19390211.2017.1366387. Epub 2017 Nov 2.

  PMID: 29095653 BACKGROUND

• Basch E, Dueck AC, Rogak LJ, Mitchell SA, Minasian LM, Denicoff AM, Wind JK, Shaw MC, Heon N, Shi Q, Ginos B, Nelson GD, Meyers JP, Chang GJ, Mamon HJ, Weiser MR, Kolevska T, Reeve BB, Bruner DW, Schrag D. Feasibility of Implementing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in a Multicenter Trial: NCCTG N1048. J Clin Oncol. 2018 Sep 11;36(31):JCO2018788620. doi: 10.1200/JCO.2018.78.8620. Online ahead of print.

  PMID: 30204536 BACKGROUND

• Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I, Kuroi K, Im SA, Park BW, Kim SB, Yanagita Y, Ohno S, Takao S, Aogi K, Iwata H, Jeong J, Kim A, Park KH, Sasano H, Ohashi Y, Toi M. Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy. N Engl J Med. 2017 Jun 1;376(22):2147-2159. doi: 10.1056/NEJMoa1612645.

  PMID: 28564564 BACKGROUND

• A. R. Elif, K. T. Yucel, A. B. Ekincioglu, and I. Gullu, ''Capecitabine induced hand-foot syndrome: a systematic review of case reports,'' Clinical and Experimental Health Sciences 9, no. 2 (2019): 178-91.

  BACKGROUND

MeSH Terms

Conditions

Hand-Foot Syndrome

Interventions

lawsone; Diagnosis-Related Groups

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Prospective Payment System; Reimbursement Mechanisms; Insurance, Health, Reimbursement; Financing, Organized; Economics; Health Care Economics and Organizations

Study Officials

• Berna Kurt, Assistant professor

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 18, 2025
• Study Start: October 15, 2018
• Primary Completion: December 15, 2018
• Study Completion: December 31, 2019
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)