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Effectiveness of Medical Taping Concept in Cancer Patients

Early Phase 1
Conditions
Cancer-related Problem/Condition
Interventions
Device: Cure Tape™ covering T 7 and T 8 dermatomes
Device: Cure Tape™ away from dermatomes T 7 and T 8
Registration Number
NCT02823314
Lead Sponsor
Universidad Miguel Hernandez de Elche
Brief 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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
20
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention groupCure Tape™ covering T 7 and T 8 dermatomesOne 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.
Placebo groupCure Tape™ away from dermatomes T 7 and T 8Two 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.
Primary Outcome Measures
NameTimeMethod
Difference between Number of times you have vomited during the first 24 hours after the first chemotherapy session and after the second chemotherapy session24 hours after the first chemotherapy session and 24 hours after the second chemotherapy session

1, 2, 3, 4, 5, .........

Difference between nausea after the first chemotherapy session and after the second chemotherapy session24 hours after the first chemotherapy session and 24 hours after the second chemotherapy session

Nausea (Yes / No)

Difference between Intensity of nausea in the experience of the participant after the first chemotherapy session and after the second chemotherapy sessionintervention and pre-intervention24 hours after the first chemotherapy session and 24 hours after the second chemotherapy session

numerical scale from 0 to 10 (0 = No / 10 = maximum)

Secondary Outcome Measures
NameTimeMethod
Difference between Quality of life post-intervention and pre-intervention24 hours after chemotherapy and 4 days after chemotherapy

EQ-5D™ is a standardised instrument for use as a measure of health outcome

Trial Locations

Locations (1)

Hospital de San Juan

🇪🇸

Sant joan DÁlacant, Alicante, Spain

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