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Completed

NCT Number: NCT04929808

Novel Skin Care Product for the Management of Acute Radiodermatitis

Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new radiotherapy (RT) techniques. Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing RT.

Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the RTskin project, a novel emollient to tackle ARD has been developed.

The RTskin project general aim is to evaluate the efficacy of a novel skincare product to manage ARD in breast cancer patients.

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Key information

Conditions

Radiodermatitis; Acute Dermatitis Neoplasms Radiation Dermatitis Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Ziekenhuis VZW

Hasselt, Limburg, 3500, Belgium

About this study

Primary objective Evaluate the efficacy of a novel emollient for the management of ARD in comparison with the current standard of care in breast cancer patients

Secondary Objective 1 Compare the ARD-related symptoms of in breast cancer patients treated with the novel emollient and the standard institutional skin care.

Secondary Objective 2 Compare the dermatologic quality of life of in breast cancer patients treated with the novel emollient and the standard institutional skin care.

Secondary Objective 3 Correlate the severity of ARD with the applied RT parameters and personal - medical characteristics

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of breast cancer and underwent lumpectomy or mastectomy
  • Scheduled for radiotherapy: hypofractionation regimen (16 or 16+5 boost fractions) at the Jessa Hospital (Hasselt, BE)
  • Age ≥ 18 years
  • Able to comply to the study protocol
  • Able to sign written informed consent
  • Signed written informed consent

Exclusion criteria

  • Previous irradiation to the breast region
  • Metastatic disease
  • Patients with pre-existing skin rash, ulceration or open wound in the treatment area
  • Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator •- Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator

Treatment and study plan

Hydrating emollient for acute radiodermatitis

Other

The emollient has a calming effect, and hydrating and anti-oxidative properties.

An absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.

Standard institutional skin care

Other

The control patients will receive the institutional standard skin care, which includes the application of Flamigel® (Flen Pharma, Kontich, BELGIUM). In addition, Mepilex® (Mölnlycke Health Care, Berchem, Belgium), an absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.

Primary outcomes

  1. Skin reaction evaluation

    Time frame: Baseline

    The patients skin reactions will be evaluated by the modified version of the RTOG criteria

  2. Skin reaction evaluation

    Time frame: At fraction 15-16 of radiotherapy (week 3 )

    The patients skin reactions will be evaluated by the modified version of the RTOG criteria

  3. Skin reaction evaluation

    Time frame: At fraction 20-21 of radiotherapy (week 4) in case of a tumor boost

    The patients skin reactions will be evaluated by the modified version of the RTOG criteria

Secondary outcomes

  1. Patient subjective evaluation of skin reactions

    Time frame: Baseline

    The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale

  2. Patient subjective evaluation of skin reactions

    Time frame: Week 1 of radiotherapy

    The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale

  3. Patient subjective evaluation of skin reactions

    Time frame: Week 2 of radiotherapy

    The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale

  4. Patient subjective evaluation of skin reactions

    Time frame: At fraction 15/16 of radiotherapy (week 3)

    The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale

  5. Patient subjective evaluation of skin reactions

    Time frame: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost

    The patients will be asked to complete a questionnaire to evaluate the intensity and frequency of five common symptoms of skin reactions: pruritus, dryness, erythema, burning sensation, and pain on an 11-point Numerical Rating Scale

  6. Quality of life assessment

    Time frame: Baseline

    The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).

  7. Quality of life assessment

    Time frame: At fraction 15/16 of radiotherapy (week 3)

    The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).

  8. Quality of life assessment

    Time frame: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost

    The skindex-29 is a validated instrument to measures patients' QoL specifically correlated with skin conditions. It has 3 scales addressing emotions (10 items), symptoms (7 items) and functioning (12 items).

  9. Patients' satisfaction with the therapeutic intervention

    Time frame: At fraction 15/16 of radiotherapy (week 3)

    The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products. All these items will be evaluated by using a numerical rating scale (NRS).

  10. Patients' satisfaction with the therapeutic intervention

    Time frame: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost

    The patients will be asked to evaluate the general pleasantness and soothing effect of the skin care products. Furthermore, they will be asked to score their global satisfaction with the skin care products. All these items will be evaluated by using a numerical rating scale (NRS).

  11. Pruritus evaluation

    Time frame: Baseline

    The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria

  12. Pruritus evaluation

    Time frame: At fraction 15/16 of radiotherapy (week 3)

    The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria

  13. Pruritus evaluation

    Time frame: At fraction 20/21 of radiotherapy (week 4) in case of a tumor boost

    The patients' degree of pruritus will be evaluated by the NCI-CTCAE V5 criteria

Other outcomes

  1. General patient-, disease-, and treatment-related information

    Time frame: Baseline

    General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, radiotherapy regime.

  2. General patient-, disease-, and treatment-related information

    Time frame: Week 4 of radiotherapy

    General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, radiotherapy regime.

  3. General patient-, disease-, and treatment-related information

    Time frame: Two weeks post-radiotherapy (follow-up)

    General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (i.e., gender, age, smoking history, work habits, physical activity, skin condition, alcohol use, and medication use). Furthermore, information about disease- and treatment-related risk factors will be collected through medical records (e.g., tumor type and stage, tumor site, treatment type, radiotherapy regime.

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Collaborators

  • Hasselt University

Registry information

Official study title

Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients

Acronym: RTSkin

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2021
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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