Effectiveness of Medical Taping Concept in Cancer Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer-related Problem/Condition
• Intervention / Treatment: Device: Cure Tape™ covering T 7 and T 8 dermatomes; Device: Cure Tape™ away from dermatomes T 7 and T 8

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Maria Isabel Tomás-Rodríguez, Doctor; Phone Number: 607326334; Email: mitomas@umh.es

Study Locations

• Spain
  • Alicante
    • Sant joan DÁlacant, Alicante, Spain, 03550
      • Recruiting
      • Hospital de San Juan
      • Contact: M Del Rosario Asensio-García, Doctor; Phone Number: +34 676 42 87 14; Email: chaas@umh.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; One piece of a special hypoallergenic adhesive tape, called Cure Tape®, they will have a size of 12-20 cm and will be attached in the front and back torso area on the T7- T8 dermatomes.	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.; Other Names: Kinesio Taping
PLACEBO_COMPARATOR: Placebo group; Two piece of a special hypoallergenic adhesive tape, called Cure Tape®, have a size of 2.5 cm x 2 cm and they will have to be placed near the greater trochanter area.	Device: 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.; Other Names: Kinesio Taping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidad Miguel Hernandez de Elche
• Collaborators: Hospital Universitario San Juan de Alicante

Publications and helpful links

General Publications

• 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.
• 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. No abstract available.
• 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.
• Huertas-Fernandez MJ, Martinez-Bautista MJ, Sanchez-Martinez I, Zarzuela-Ramirez M, Baena-Canada 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.
• 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 Dec;26(12):2899-2905. doi: 10.1007/s11695-016-2214-0.
• Tomas-Rodriguez MI, Palazon-Bru A, Martinez-St John DRJ, Toledo-Marhuenda JV, Asensio-Garcia MDR, Gil-Guillen 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): October 1, 2016
• Study Completion (ANTICIPATED): June 1, 2017

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (ESTIMATE): July 6, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 6, 2016
• Last Update Submitted That Met QC Criteria: June 30, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 16/308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Spanish law: 15/1999 Data Protection