Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

MARY DUOL REPAIR BALM IN THE PREVENTION OR REDUCING ANTINEOPLASIC AGENTS' SKIN TOXICITY (B-DUOL)

1. august 2016 opdateret af: Patricia Seoane, Basque Health Service

EFFECTIVENESS OF MARY D'UOL REPAIR BALM FOR PREVENTING AND / OR REDUCING TOXICITY SKIN IN PATIENTS WITH CANCER AND TREATMENT WITH ANY Antineoplastic Agent. RANDOM CLINICAL TRIAL.

Capecitabine is a drug that produces dermatologic toxicity frequently (palmoplantar erythrodysesthesia, rash , alopecia , erythema , dryness, pruritus, hyperpigmentation , rash, peeling , dermatitis , abnormal pigmentation, and less often blistering, skin ulcers , photosensitivity reactions, swelling of the face and purple) . The impact in patients' quality of life is great, so We had decided to conduct a randomized clinical trial to evaluate the effectiveness Mary D' uol balm preventing dermatologic toxicity in patient treated with capecitabine .

Design: Randomized clinical trial phase II, in parallel and double-blind groups

Target population : Patients with colon cancer stage II or III ( Dukes' C ) , who will initiate treatment with capecitabine monotherapy.

Inclusion criteria: Over 18 years, II or III colon (Dukes' C) colon cancer, primary diagnosis, capecitabine monotherapy, sign the informed consent.

Primary endpoint: Dermatologic toxicity (yes / no) Statistical analysis: The primary endpoint (percentage of patients that develop dermalogic toxocity in both groups) will be analyzed by a logistics regression model

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Intervention: Preventive treatment of dermatologic toxicities begin on the day of initiation of treatment with Xeloda, capecitabine + oxaliplatin, Adriamycin Liposomial or cytarabine

The product will be applied throughout the body in abundant quantities so that the skin is perfectly hydrated. It is applied twice daily (after showering and evening), gently massaging the area until completely absorbed.

The product will be provided at the unit of oncology pharmacy, when the patient is randomized. 3 packs per cycle will be provided. If not enough (because the patient has greater surface area) will be supplied more. Each time you start a new cycle 3 new packages will be delivered.

The patient will not apply any other cosmetic product in the treated areas.

In addition all patients regardless of the group will receive recommendations for reducing the appearance of skin problems caused by these type of drugs.

The study will have a total duration of 24 weeks (8 cycles of chemotherapy), except in cases of patients requiring a cycle delay for filing toxicity. In these patients the total duration of the study must be sufficient to end the eighth cycle.

If the side effects are so severe that greatly affect the quality of life of the patient and the doctor thinks fit, may prescribe drug treatment.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

86

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Álava
      • Vitoria-Gasteiz, Álava, Spanien, 01009
        • Rekruttering
        • University hospital of Araba
        • Kontakt:
          • Arantza Saez de Lafuente
        • Ledende efterforsker:
          • Carlos Peña

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Over 18 years.
  • Sign the informed consent

Exclusion Criteria:

  • Patients with neoadjuvant treatment.
  • Patients with dermatologic diseases.
  • Patients treated with corticosteroids.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BALM ARM
The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. Will be applied twice a day (after showering and at night), massaging the area until completely absorption.
Procedure: BALM ARM
The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption. Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms.
Placebo komparator: PLACEBO ARM
It be applicated in like manner that balm arm
Procedure: PLACEBO ARM
The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption. Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of patients who develop dermatologic toxicity.
Tidsramme: 3 moths
Compare the percentage of patients who develop dermatologic toxicity in any grade (1-5) between intervention and control group at three months of starting treatment, through CTCAE scale (National Cancer Institute Common Toxicity Criteria).
3 moths

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Need of pharmacological treatment to mitigate toxicity
Tidsramme: 3 months
Compare the percentage of patients in both groups who required pharmacological treatment to mitigate the dermatologic toxicity produced by chemotherapy
3 months
Quality of life
Tidsramme: 3 months
Compare the quality of life in both groups at three months, through the Skindex 29 scale to evaluate the quality of life due to skin disease.
3 months
Percentaje of patients who have reduces skin toxicity
Tidsramme: 3 months
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Basque Health Service

Efterforskere

  • Studiestol: Arantza Sáez de la Fuente, Msc, Basque Health Service (Research Unit)
  • Ledende efterforsker: Patricia Seaone, MD, Basque Health Service (Research Unit)
  • Studiestol: Raquel Cobos, Msc, Basque Health Service (Research Unit)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2014

Primær færdiggørelse (Forventet)

1. juni 2017

Studieafslutning (Forventet)

1. juni 2017

Datoer for studieregistrering

Først indsendt

14. januar 2014

Først indsendt, der opfyldte QC-kriterier

14. januar 2014

Først opslået (Skøn)

15. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MD-01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Dermatitis, Adverse Drug Reaction

  • Chulalongkorn University
    Mahidol University; Chiang Mai University; Phramongkutklao College of Medicine... og andre samarbejdspartnere
    Ukendt
    Alvorlige kutane bivirkninger i Thailand (ThaiSCAR)
    Lægemiddelreaktion med eosinofili og systemiske symptomer | Toksisk epidermal nekrolyse | Akut generaliseret eksantematøs pustulose | Steven-Johnsons syndrom | Generaliseret Bullous Fixed Drug Eruption
    Thailand

Kliniske forsøg med BALM ARM

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Latvia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner