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Outcome Measures

Primary Outcomes (1)

Sensory discomfort appearance in hands and/or feet as a measure of quality of life
The appearance of sensory sensations resulting from CIPN will be detected by the oncologists' follow-up. The oncologists will indicate the treatment cycle in which the neuropathy discomfort appears and their degree in the data collection notebook. The study involves following the patient from the first cycle of chemotherapy until one month after the end of treatment.
The estimated period of time over which the event is assessed is up to16 weeks, which correspond from the first CT cycle (cycles are received once a week, 12 CT cycles) up to one month later.

Secondary Outcomes (1)

Skin Discomfort Severity
Questionnaire was done every three weeks until one month after treatment was finished.

Study Arms (2)

PB-011

Patients starting chemotherapy treatment are given (double blinded) moisturizing cream PB-011 to use once a day in hands. If sensory discomfort appears in hands or feet, the dosage could be increased up to twice a day in hands and feet.

PB-012

Patients undergoing chemotherapy treatment are given (double blinded) moisturizing cream PB-012 to use once a day in hands. If sensory discomfort appears in hands or feet, the dosage could be increased up to twice a day in hands and feet.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

The study population was anyone over 18 years of age who met the inclusion and exclusion criteria and who was about to start chemotherapy treatment.

You may qualify if:

To be older than 18 year old

Related Publications (16)

Bae EH, Greenwald MK, Schwartz AG. Chemotherapy-Induced Peripheral Neuropathy: Mechanisms and Therapeutic Avenues. Neurotherapeutics. 2021 Oct;18(4):2384-2396. doi: 10.1007/s13311-021-01142-2. Epub 2021 Oct 21.

PMID: 34676514BACKGROUND

Chen X, Gan Y, Au NPB, Ma CHE. Current understanding of the molecular mechanisms of chemotherapy-induced peripheral neuropathy. Front Mol Neurosci. 2024 Apr 10;17:1345811. doi: 10.3389/fnmol.2024.1345811. eCollection 2024.

PMID: 38660386BACKGROUND

Study Officials

Antonio Sonia Servitja, Oncologist

Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)

PRINCIPAL INVESTIGATOR

Maria Castro-Henriques, Oncologist

Servicio de Oncología Médica, Hospital del Mar, 08003 Barcelona (Spain)

PRINCIPAL INVESTIGATOR

Iñaki Álvarez-Busto, Oncologist

Servicio de Oncología Médica, Hospital Universitario Miguel Servet, 50009 Zaragoza (Spain)

PRINCIPAL INVESTIGATOR

Maria Asunción Algarra-García, Oncologist

Servicio de Oncología Médica, Hospital Marina Baixa, 03570 Villajoyosa, Alicante (Spain)

Study for the Evaluation of the Degree of Skin Satisfaction of a Cosmetic Cream for Sensitive Skin in Oncological Patients Affected by a Palmoplantar Polyneuropathy Secondary to Chemotherapy.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

PB-011

PB-012

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (16)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

PB-011

PB-012

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (16)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations