"Evaluation of a Non-Pharmacological Skin Care Intervention for the Prevention and Treatment of Skin Toxicities Caused by Immunotherapy in Cancer Patients"

January 7, 2026 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Due to recent approvals, a significant number of adult cancer patients are undergoing treatment with checkpoint inhibitor antibodies. While these treatments have revolutionized cancer care, they come with inherent risks of toxicities, primarily mediated by the patient's own immune system.

Among the most common side effects are dermatological toxicities, which although generally mild, significantly impact patients' quality of life. These issues are often underdiagnosed and lack proactive interventions. This study aims to demonstrate that proactive measures using Niacinamide and Shea Butter can either prevent or mitigate the severity of these toxicities.

Thus, this study seeks to contribute novel insights into managing patients undergoing active immunotherapy, a field that remains relatively unexplored. Dermocosmetic products used in both armes of this trial are already approved for over-the-counter use, ensuring accessibility without prescription.

Study Hypothesis: The prophylactic use of Niacinamide and Shea Butter in dermocosmetic products reduces the frequency and severity of immune-mediated skin toxicities in cancer patients receiving checkpoint inhibitor antibodies.

This single-center trial will be conducted at Hospital de la Santa Creu i Sant Pau, employing a parallel arm design with randomization overseen by the center's statistician. Participants will be randomly assigned to either arm, with an active control group to monitor dermocosmetic product usage frequency and type. The blinding protocol will be single-blind to ensure unbiased evaluation.

The study aims to assess the incidence of pruritus among adult cancer patients receiving checkpoint inhibitor antibodies, correlating these findings with the efficacy of dermocosmetic products containing Niacinamide and Shea Butter. Additionally, it will evaluate the impact on the quality of life of these patients.

The intervention group will receive soap and an emollient formulated with Shea Butter and Niacinamide, while the control group will use products containing Argan Oil and Coconut Butter. Both groups will undergo a 6-month treatment regimen.

Key endpoints include:

  • Skin pruritus
  • Relationship between skin condition and quality of life Consecutive non-probabilistic sampling will be used to recruit all patients with solid tumors initiating immunotherapy.

Using GranMo calculator version 7.2 with 95% confidence and a precision of +/- 0.07, the study calculated a sample size of 128 patients. Recruitment will aim for 130 patients to account for potential attrition, split evenly between Arm 1 and Arm 2.

Data analysis will involve importing, cleaning, and recoding variables followed by univariate analysis using IBM SPSS v.25 The study will adhere strictly to international ethical standards for clinical research, including the Declaration of Helsinki and Good Clinical Practice guidelines. Participants will be fully informed about the study's nature, objectives, procedures, potential risks, benefits, and their right to withdraw without impact on their care.

An information/consent form has been designed accordingly. Participants will receive hygiene and hydration products at no cost, though no financial compensation will be provided.

Monitoring, auditing, reviews by the CEIC, and regulatory inspections will be conducted to ensure adherence to protocol and regulatory requirements.

The choice of control treatment aims to replicate real-world conditions while assessing approved products. Participants will be followed for 6 months from informed consent signing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital De La Santa Creu I Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patient
  • Diagnosed with any solid cancer
  • Initiating treatment with checkpoint inhibitor antibodies
  • Able to speak and understand Spanish and/or Catalan

Exclusion Criteria:

  • Unable to sign informed consent
  • Unable to comprehend the study for giving consent
  • Language barrier: Does not speak or understand Spanish or Catalan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Niacinamide and Shea Butter
Other: Shea Butter and Niacinamide
Thus, this study seeks to contribute novel insights into managing patients undergoing active immunotherapy, a field that remains relatively unexplored. Dermocosmetic products used in both armes of this trial are already approved for over-the-counter use, ensuring accessibility without prescription.
Active Comparator: Argan Oil and Coconut Butter
Other: Argan Oil and Coconut Butter
Thus, this study seeks to contribute novel insights into managing patients undergoing active immunotherapy, a field that remains relatively unexplored. Dermocosmetic products used in both armes of this trial are already approved for over-the-counter use, ensuring accessibility without prescription.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective 1: Itching
Time Frame: 19 months
Evaluate the occurrence of itching in adult cancer patients receiving treatment with Checkpoint Inhibitor Antibodies in relation to prevention with the use of dermocosmetic products based on Niacinamide and Shea Butter. The itch is measured using the itch intensity scale. It is a scale validated in both English and Spanish.
19 months
Objective 2: Skin quality of life
Time Frame: 19 months
Evaluate the quality of life of adult cancer patients receiving treatment with Checkpoint Inhibitor Antibodies regarding skin health. The quality of life related to skin is evaluated using the Dermatology Life Quality Index (DLQI).
19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2022

Primary Completion (Actual)

December 21, 2023

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-CUT-2021-109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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