Effectiveness of Medical Taping Concept in Cancer Patients

NCT ID: NCT02823314

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer-related Problem/Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cure Tape™ covering T 7 and T 8 dermatomes

Intervention Type DEVICE

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.

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.

Group Type PLACEBO_COMPARATOR

Cure Tape™ away from dermatomes T 7 and T 8

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Kinesio Taping Kinesio Taping

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario San Juan de Alicante

OTHER

Sponsor Role collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

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María Isabel Tomás-Rodríguez, PT

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital de San Juan

Sant Joan DÁlacant, Alicante, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Maria Isabel Tomás-Rodríguez, Doctor

Role: CONTACT

607326334

Facility Contacts

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M Del Rosario Asensio-García, Doctor

Role: primary

+34 676 42 87 14

References

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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.

Reference Type BACKGROUND
PMID: 19760035 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25412832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18299681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20206564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27289457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26564807 (View on PubMed)

Related Links

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http://www.aevnm.com/

Newsletters Medical Taping concept in Spain

Other Identifiers

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16/308

Identifier Type: -

Identifier Source: org_study_id

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