NCT02823314

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2016

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 6, 2016

Status Verified

June 1, 2016

Enrollment Period

4 months

First QC Date

June 28, 2016

Last Update Submit

June 30, 2016

Conditions

Cancer-related Problem/Condition

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Difference between Quality of life post-intervention and pre-intervention

    24 hours after chemotherapy and 4 days after chemotherapy

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Cure Tape™ covering T 7 and T 8 dermatomesDEVICE

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.

Also known as: Kinesio Taping
Intervention group
Cure Tape™ away from dermatomes T 7 and T 8DEVICE

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.

Also known as: Kinesio Taping
Placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not suffer nausea or vomiting episodes in the previous cycle of chemotherapy,
  • To Shower inability to report nausea and / or vomiting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de San Juan

Sant Joan DÁlacant, Alicante, 03550, Spain

RECRUITING

Related Publications (6)

  • 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.

    PMID: 19760035BACKGROUND

  • 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.

    PMID: 25412832BACKGROUND

  • 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.

    PMID: 18299681BACKGROUND

  • 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.

    PMID: 20206564BACKGROUND

  • 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.

    PMID: 27289457BACKGROUND

  • 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.

    PMID: 26564807BACKGROUND

Related Links

Central Study Contacts

Maria Isabel Tomás-Rodríguez, Doctor

CONTACT

607326334mitomas@umh.es

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 6, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2016

Study Completion

June 1, 2017

Last Updated

July 6, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Spanish law: 15/1999 Data Protection

Locations

ES(1)