Effectiveness of Medical Taping Concept in Cancer Patients

Cancer-related Problem/Condition Clinical Trial

Official title:

Effectiveness of Medical Taping Concept Applied in the T7-T8 Dermatome in Nausea and Vomiting After Chemotherapy in Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02823314
• Other study ID #: 16/308
• Status: Recruiting
• Phase: Phase 0
• First received: June 28, 2016
• Last updated: June 30, 2016
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Universidad Miguel Hernandez de Elche
• Contact: Maria Isabel Tomás-Rodríguez, Doctor
• Phone: 607326334
• Email: mitomas[@]umh.es
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Nausea and vomiting are two of the side effects associated with the most common antineoplastic chemotherapy treatments. The Medical Taping Concept (MTC) is an economical technique, easy to apply. This is a technique that may help reduce nausea and vomiting after application of chemotherapy in cancer patient.

Description:

Nausea and vomiting are two of the side effects associated with the most common antineoplastic chemotherapy treatments. There are some studies that support the use of physical measures such as TENS or acupuncture to lessen these effects.

The Medical Taping Concept (MTC) is an economical technique, easy to apply and few side effects. In some manuals on this technique the possibility that it may act to reduce nausea and vomiting described. Sim But after a comprehensive literature search have not found jobs to support these assumptions. With this work, the research team will attempt to obtain evidence on the effects of its application in the areas of influence of the dermatome T7 and T8. For this, two adhesive tapes of this type of bandage is placed on the front and back on a group of patients after receiving chemotherapy session and compared with a control group that will apply this technique outside the dermatome indicated . Both groups will receive antiemetics according to the service routine. If the hypothesis were positive it could extend the application of this simple technique to cancer patients from other centers in order to help reduce nausea and vomiting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Neoadjuvant and adjuvant breast cancer

• To have been diagnosed with a severe comorbid disorder

• To have received at least the first cycle of emetogenic chemotherapy

Exclusion Criteria:

• Not suffer nausea or vomiting episodes in the previous cycle of chemotherapy,

• To Shower inability to report nausea and / or vomiting.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer-related Problem/Condition

Intervention

Device:
• Cure Tape™ covering T 7 and T 8 dermatomes
The intervention group will have to apply two strips of special hypoallergenic tape called Cure Tape™ that will have a size of 20 x 5 cm and they will have to be placed on the T7-T8 dermatome area.
• Cure Tape™ away from dermatomes T 7 and T 8
The control group will have to apply two strips of special hypoallergenic tape called Cure Tape™ that will have a size of 5 x 4 cm and they will have to be placed near the greater trochanter area.

Locations

Country	Name	City	State
Spain	Hospital de San Juan	Sant joan DÁlacant	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Hospital Universitario San Juan de Alicante

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Abdel-Kadar M. Percutaneous Electrical Neurostimulation (PENS) of Dermatome T6 with an Ambulatory Self-applied Patch vs PENS of Dermatome T6 with Conventional Procedure: Effect on Appetite and Weight Loss in Moderately Obese Patients. Obes Surg. 2016 Jun 11. [Epub ahead of print] — View Citation

Chao LF, Zhang AL, Liu HE, Cheng MH, Lam HB, Lo SK. The efficacy of acupoint stimulation for the management of therapy-related adverse events in patients with breast cancer: a systematic review. Breast Cancer Res Treat. 2009 Nov;118(2):255-67. doi: 10.1007/s10549-009-0533-8. Review. — View Citation

Ezzo J, Richardson MA, Vickers A, Allen C, Dibble S, Issell BF, Lao L, Pearl M, Ramirez G, Roscoe JA, Shen J, Shivnan JC, Streitberger K, Treish I, Zhang G, Manheimer E. WITHDRAWN: Acupuncture-point stimulation for chemotherapy-induced nausea or vomiting. Cochrane Database Syst Rev. 2014 Nov 21;(11):CD002285. doi: 10.1002/14651858.CD002285.pub3. Review. — View Citation

Gardani G, Cerrone R, Biella C, Galbiati G, Proserpio E, Casiraghi M, Arnoffi J, Meregalli M, Trabattoni P, Dapretto E, Giani L, Messina G, Lissoni P. A progress study of 100 cancer patients treated by acupressure for chemotherapy-induced vomiting after failure with the pharmacological approach. Minerva Med. 2007 Dec;98(6):665-8. — View Citation

Huertas-Fernández MJ, Martínez-Bautista MJ, Sánchez-Martínez I, Zarzuela-Ramírez M, Baena-Cañada JM. [Analysis of the effectiveness of an antiemetic protocol used in an oncology division]. Farm Hosp. 2010 May-Jun;34(3):125-38. doi: 10.1016/j.farma.2009.11.001. Spanish. — View Citation

Tomás-Rodríguez MI, Palazón-Bru A, Martínez-St John DR, Toledo-Marhuenda JV, Asensio-García Mdel R, Gil-Guillén VF. Effectiveness of medical taping concept in primary dysmenorrhoea: a two-armed randomized trial. Sci Rep. 2015 Nov 13;5:16671. doi: 10.1038/srep16671. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between Number of times you have vomited during the first 24 hours after the first chemotherapy session and after the second chemotherapy session	1, 2, 3, 4, 5, .........	24 hours after the first chemotherapy session and 24 hours after the second chemotherapy session	No
Primary	Difference between nausea after the first chemotherapy session and after the second chemotherapy session	Nausea (Yes / No)	24 hours after the first chemotherapy session and 24 hours after the second chemotherapy session	No
Primary	Difference between Intensity of nausea in the experience of the participant after the first chemotherapy session and after the second chemotherapy sessionintervention and pre-intervention	numerical scale from 0 to 10 (0 = No / 10 = maximum)	24 hours after the first chemotherapy session and 24 hours after the second chemotherapy session	No
Secondary	Difference between Quality of life post-intervention and pre-intervention	EQ-5D™ is a standardised instrument for use as a measure of health outcome	24 hours after chemotherapy and 4 days after chemotherapy	No

External Links

•   Newsletters kinesiology-tape
•   Newsletters Medical Taping concept
•   Newsletters Medical Taping concept in Spain