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Cancer-related Problem/ConditionEarly Phase 1NCT02823314

Effectiveness of Medical Taping Concept in Cancer Patients

A Early Phase 1 study testing Cure Tape™ covering T 7 and T 8 dermatomes and Cure Tape™ away from dermatomes T 7 and T 8 in people with Cancer-related Problem/Condition, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Cancer-related Problem/Condition
What is being tested?
Cure Tape™ covering T 7 and T 8 dermatomes and Cure Tape™ away from dermatomes T 7 and T 8
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteSpain
Study dates
Jun 2016to Jun 2017
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Maria Isabel Tomás-Rodríguez, Doctor contact

607326334

mitomas@umh.es

Spain1 site, 1 recruiting

  • Hospital de San Juan

    Sant Joan DÁlacant, Alicante, 03550

    M Del Rosario Asensio-García, Doctor, +34 676 42 87 14, chaas@umh.es

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Cure Tape™ covering T 7 and T 8 dermatomes, Cure Tape™ away from dermatomes T 7 and T 8

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cure Tape™ covering T 7 and T 8 dermatomesDevice

    Also called Kinesio Taping

    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 8Device

    Also called Kinesio Taping

    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.

Study groups in NCT02823314
Study groupRoleWhat they receive
Intervention groupExperimentalOne 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.
Receives: Device: Cure Tape™ covering T 7 and T 8 dermatomes
Placebo groupPlacebo comparatorTwo 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.
Receives: Device: Cure Tape™ away from dermatomes T 7 and T 8

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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, .........

    Measured: 24 hours after the first chemotherapy session and 24 hours after the second chemotherapy session

  2. Difference between nausea after the first chemotherapy session and after the second chemotherapy session

    Nausea (Yes / No)

    Measured: 24 hours after the first chemotherapy session and 24 hours after the second chemotherapy session

  3. 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)

    Measured: 24 hours after the first chemotherapy session and 24 hours after the second chemotherapy session

Secondary outcomes (1)

  1. Difference between Quality of life post-intervention and pre-intervention

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

    Measured: 24 hours after chemotherapy and 4 days after chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionOct 2016 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02823314
Sponsor's protocol ID
16/308
Status last verified
Jun 2016
First submitted
28 Jun 2016
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Spanish law: 15/1999 Data Protection

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.

    PubMed 19760035

  • 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.

    PubMed 25412832

  • 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.

    PubMed 18299681

  • 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.

    PubMed 20206564

  • 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.

    PubMed 27289457

  • 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.

    PubMed 26564807

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Cure Tape™ covering T 7 and T 8 dermatomes and Cure Tape™ away from dermatomes T 7 and T 8 in people with Cancer-related Problem/Condition, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maria Isabel Tomás-Rodríguez, Doctor (607326334, mitomas@umh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference between Number of times you have vomited during the first 24 hours after the first chemotherapy session and after the second chemotherapy session (time frame: 24 hours after the first chemotherapy session and 24 hours after the second chemotherapy session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02823314, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

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