Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Alopecia

Alopecia Areata

Hypotrichosis

Hair Diseases

Skin Diseases

Pathological Conditions, Anatomical

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Epirubicin

All patients will undergo photobiomodulation therapy sessions three times a week for the total duration of 12 weeks starting at their last CT administration.

Photobiomodulation therapy

Jeroen Mebis, prof. dr.

Joy Lodewijckx, drs.

Jeroen Mebis, prof.dr.

Chemotherapy (CT) remains an important treatment modality for breast cancer patients. Unfortunately, this systemic treatment comes with many quality of life impairing complications. Chemotherapy-induced alopecia (CIA) occurs in about 65% of the patients. Hair loss due to CT is reversible, but hair regrowth requires several months to a year after CT. Currently, the only available preventive measure is based on scalp cooling. Nevertheless, this treatment has a highly variable success rate and it brings along several side effects. Photobiomodulation therapy (PBMT) is a new, preventive and therapeutic technique in the supportive care of cancer patients. It uses visible and (near)- infrared light produced by laser diodes or light-emitting diodes (LED) at a low power to stimulate tissue repair and reduce inflammation and pain. The investigator's research team demonstrated already that PBMT can prevent oral mucositis and acute radiodermatitis. The aim of this project is to explore the use of PBMT in the management of CIA. Results of this project will lead to an improvement of the patients' quality of life after CT.

PBMT for the Management of CIA ( HAIRLASER )

Photobiomodulation Therapy for the Management of Chemotherapy-induced Alopecia: a Randomized, Placebo-controlled Feasibility Trial

A mechanical visual analogue scale (VAS) will be used to evaluate the patients' hair regrowth based on photographs taken at the four time points. The patients will be asked to indicate their subjective experience of hair regrowth. This score is associated with a certain score, in which 0 = 'total baldness' and 10 = 'full scalp coverage'.

A validated questionnaire of the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module

The patients' global satisfaction with the PBMT/sham therapy will be evaluated using a numerical rating scale (NRS) from 0 (minimum score) to 10 (maximum score)

Jessa Hospital

Hasselt University

Principal Investigator

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Single-arm study. Participants enrolled engaged in a 12-week exercise program.

12-week physical activity intervention. 60 minute group-based exercise classes held once per week. Home-based exercise recommendations provided weekly along with basic take-home exercise equipment. Optional palliative care consultations offered.

Physical Activity for Advanced Cancer Treatment (PAACT)

Nicole r Culos-Reed, PhD

Although physical activity (PA) is commonly used to manage symptoms and enhance quality of life (QOL) in cancer survivors, relatively little is known regarding the benefits in advanced multiple myeloma (MM). The primary aims of the Physical Activity in Advanced Cancer Treatment (PAACT) intervention were to examine (1) program feasibility and (2) potential impact on patient outcomes. It is hypothesized that an exercise intervention will be feasible and potentially impactful.

While the introduction of novel and more effective treatments has seen improved survival in multiple myeloma (MM), the aggressive nature of the disease and these corresponding agents can have a debilitating impact on quality of life (QOL). Exercise can help manage symptoms and enhance QOL in cancer survivors, however relatively little is known regarding the feasibility or benefits of exercise in MM. The purpose of this study was to examine the feasibility of a group- and home-based exercise intervention for individuals with advanced MM. In this single arm study, advanced MM patients (DS stage II-III) participated in a 12-week aerobic and resistance training intervention, with the option of palliative care consultation. Participants attended once weekly supervised group exercise classes and received individually tailored home exercise booklets. Validated measures of physical functioning and patient-reported outcomes, including QOL, fatigue, anxiety, depression, and self-compassion were obtained at baseline and 12-weeks (post-intervention). Optional semi-structured interviews were conducted halfway (week 6) and at the end of the intervention (week 12)

The Feasibility of a Physical Activity Intervention for Advanced Multiple Myeloma Patients

Assessing the Feasibility and Benefits of a Physical Activity Intervention for Advanced Multiple Myeloma Patients

Recruitment as defined by the proportion of patients who participate in the study, out of the total number of eligible patients.

Attendance is defined by the number of weekly group-exercise classes attended.

Attrition is defined as the number of participants who dropped out of the program after completing the baseline assessment.

Safety is described as any adverse event reported by the participants during the 12-week program or fitness assessments, related to program participation.

Total grip strength in kilograms is recorded as the sum from the best score of two trials recorded for each hand. Differences between baseline and post-intervention assessments are evaluated.

Chair stand test records the number of times a participant can stand from a seated position in 30 seconds. Differences between baseline and post-intervention assessments are evaluated.

In the Chair Sit and Reach Flexibility test, lower body flexibility is assessed by having the participant sit on the edge of a seat. The participant extends the leg being tested in front of the hip, with the heel on the floor and the ankle dorsiflexed approximately 90 degrees. The participant flexes the untested leg so that the sole of the foot is flat on the floor about 6 to 12 inches to the side of the body's midline. With the extended leg as straight as possible and the hands on top of each other (palms down), the participant slowly bends forward at the hip joint, keeping the spine as straight as possible and the head in normal alignment (not tucked) with the spine. The participant reaches down the extended leg, trying to touch the toes, and holds this position for 2 sec. A ruler is ran parallel to the participant's lower leg. Two practice trials are allowed followed by two test trials.The best measurement is taken.

In the Back-Scratch Flexibility test, upper body flexibility is assessed by asking the participant to reach, with the preferred hand (palm down and fingers extended), over the shoulder and down the back while reaching around and up the middle of the back with the other hand (palm up and fingers extended). The participant is allowed two practice trials followed by two test trials.The best measurement is taken.

The 8-foot Timed Up and Go test measures the time to move from a seated position, walk 8 feet, and return to a seated position.The best of two trials is taken.

Participant's Balance is assessed by measuring the time the participant is able to stand on one-foot. Both feet measured. A 45-second cut-off time is implemented.

In the Six-Minute Walk Test, participants are instructed to walk as far as they can for 6 min around a track. Distances are recorded to the nearest 0.5 m.

The Functional Assessment of Cancer Therapy- Multiple Myeloma (FACT-MM) questionnaire is comprised of the 27-item FACT-General (FACT-G) scale, which provides information on physical, social, emotional, and functional well-being domains in conjunction with 14 MM-specific supplementary questions. The combined subscales of physical, functional, and MM specific domains contribute to the Trial Outcome Index (TOI) score (range of 0-112). The questionnaire is rated on a 5-point Likert scale, and components can be combined to create a total score, with increases in scores representing improved quality of life.

The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire is a13-item questionnaire rated on a 5-point Likert scale, and components can be combined to create a total score, with increases in scores representing decreased fatigue.

The Hospital Anxiety and Depression Scale (HADs) questionnaire is a 14-item scale. Subscales for anxiety were calculated with a range of 0-21, with low scores (0-7) representing normal levels.

The Hospital Anxiety and Depression Scale (HADs) questionnaire is a 14-item scale. Subscales for depression were calculated with a range of 0-21, with low scores (0-7) representing normal levels.

The Self-Compassion Scale (SCS) is a 26-item scale. The following subscales are measured on a 5-point Likert scale (1 = almost never to 5= almost always): self- kindness, self-judgment, common humanity, isolation, mindfulness and over-identified items. In this study a grand mean representing an overall measure of self-compassion willl be calculated, with a higher score representing higher levels of self-compassion.

The Godin Leisure Time Exercise Questionnaire (GLTEQ) assesses current physical activity levels. Participants report on the duration and frequency of mild, moderate, and strenuous PA within a typical week over the past month. Total weekly physical activity is calculated.

Dr. Nicole Culos-Reed

Substance Related Disorders

Syndrome

Hand-Foot Syndrome

Exanthema

Drug Eruptions

Dermatitis

Hypersensitivity

Drug Hypersensitivity

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

The experimental group receives 9 sessions of photobiomodulation therapy (3x/week for 3 weeks).

Patients will receive PBM on the sole of their feet and palms of their hands

Photobiomodulation therapy (PBMT)

Jeroen Mebis, MD, PhD

Jolien Robijns, PhD

Hand-foot syndrome (HFS) is a side effect of chemotherapy. HFS is characterized by redness, swelling, and pain on the palms of the hands and/or soles of the feet, which can progress to blistering. Hand-foot skin reaction (HFSR) refers to symptoms affecting the hands and/or feet associated with multikinase inhibitors (TKIs). HFS and HFSR are painful complications that can lead to compromised daily activities, sleep-wake disturbance and impaired mobility, eventually decreasing Quality of Life (QoL).

Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. The aim of this study is to evaluate the effectiveness of PBMT in the management of HFS and HFSR.

The aim of this study is to evaluate the efficacy of PBMT in the management of HFS and HFSR in patients with cancer treated with chemotherapy or TKIs up to 2 weeks post-PBMT.

Primary objective: The study seeks primarily to determine the effectiveness of PBMT in reducing the severity of HFS and HFSR in patients with cancer of different etiology undergoing chemotherapy or TKIs, diagnosed with HFS or HFSR (grade 1-3).

Secondary objective 1 : HFS/HFSR-related symptoms

A secondary aim of this study is to evaluate if PBMT and can reduce the HFS/HSFR-related symptoms during PBM treatment and up to 2 weeks post-PBMT

Secondary Objective 2: Quality of life

A secondary aim of this study is to evaluate if PBMT can improve the patients' QoL during PBM treatment and up to 2 weeks post-PBMT

Secondary Objective 3: Patient satisfaction

A secondary aim of this study is to evaluate if patients are satisfied with PBMT as a treatment for HFS and HFSR during the treatment sessions and up to 2 weeks post-PBMT

Secondary Objective 4: PBM safety

A secondary aim of this study is to evaluate the safety of PBM in oncologic patients up to 5 years post-PBMT.

Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction

Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial

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, etc).

The possible appearance and date of local and/or regional recurrence will be collected.

The possible appearance and date of secondary tumors will be collected.

The possible appearance and date of distant metastasis will be collected.

If the patient dies within the first year after the treatment, their date of death will be collected.

If the patient dies within 2 years after the treatment, their date of death will be collected.

If the patient dies within 3 years after the treatment, their date of death will be collected.

If the patient dies within 4 years after the treatment, their date of death will be collected.

If the patient dies within 5 years after the treatment, their date of death will be collected.

The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.

The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR

A clinical photograph of the palm of patients' hands and sole of their feet

The patients will be asked to complete a questionnaire to evaluate the intensity of eight common symptoms of HFS/HFSR: pruritus, dryness, erythema, burning sensation, oedema, desquamation, blistering, and pain on an 11-point Numerical Rating Scale (NRS)

Dermatology Life Quality Index (DLQI) is a questionnaire with 10 items and is used to measure QoL of dermatological patients.

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).

The patients will be asked to evaluate their satisfaction with PBM on a 5-point Likert scale

Infections

Respiratory Tract (Lung and Bronchial) Diseases

COVID-19

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

All patients were presented the digital PROMs platform during their chemotherapy

At inclusion the patient received a unique login code which he/she used to start the care path. After signing the informed consent on the digital pathway, the patient needed to fill in the questionnaires that were presented at fixed time points throughout this study.

Based on the data collected from the questionnaires the patient received customized information and advice. In case of COVID-19, the information and advice was based on the guidelines from Sciensano and the Belgian government. If the patient suffered from side effects from the cancer therapy, they received tips and tricks how to manage these complications. The collected data was forwarded to the patient medical file. As such health care workers were be able to use this information in the patients' follow up consultations.

ePROMs assessment

During the COVID-19 pandemic, patients with cancer are subject to multiple risks (e.g. frequent hospital visits, increased infection risk, more severe clinical course, discontinued cancer treatment etc.).

Patients undergoing cancer therapy are also faced with several Quality of Life - impairing side effects. In the case of a positive COVID-19 cancer patient, the need and intensity of treating must be weighed against the possible higher risk of developing severe complications in the course of a COVID-19 infection. Nevertheless, both for COVID-19 positive and negative patients who will continue or discontinue cancer treatment throughout the pandemic, providing supportive care is more important than ever.

Digitally monitoring patient-reported outcome measures (PROMs) could offer a solution to improve the supportive care measures during cancer treatment, and certainly in times of COVID-19. Digitalized PROMS could significantly contribute to improved communication, patient satisfaction, supportive care, monitoring of cancer treatment, and detection of problems.

To date, clinical trials investigating the benefits of digital PROMS in patients with cancer during the current COVID-19 pandemic are lacking.

At the Jessa Hospital, the investigators already have experience in collecting PROMs via a digital platform (Awell Health) since 2019 for patients with breast cancer undergoing chemotherapy using validated QoL questionnaires.

The overall aim of this project is to prospectively evaluate the impact of a COVID-19 infection on the severity of the cancer therapy-related complications and the QoL of patients with cancer undergoing chemotherapy using a digital PROMs-platform.

General aim: The overall aim of this project is to prospectively evaluate the impact of a COVID-19 infection on the severity of the cancer therapy-related complications and the QoL of patients with cancer undergoing chemotherapy using a digital PROMs platform.

Objective 1: Evaluate the effect of a COVID-19 infection on the severity of cancer therapy-related side effects and patients' QoL

Rationale: The functionality of this platform will be based on three main principles:

1. The digital PROMs platform will provide patient-tailored information throughout the course of their disease and up to one month after the end of their chemotherapy concerning complications and COVID-19. This will support the cancer patients during their disease with specific advice based on the side effects they document. First, this will help comfort patients and reduce their anxiety and insecurity in these stressful times. Second, they will receive information regarding measures they can take to tackle their specific complications. Third, this will encourage patients to seek help in case of a possible COVID-19 infection and/or severe side effects by contacting the oncological support team or their physician.
2. The platform will prospectively collect QoL data using validated patient-reported questionnaires and specific COVID-19 questionnaires via a mobile application.
3. The platform will be fully integrated into the electronic health record (EHR) of the patient and will provide a structured report of the questioned complications for the physician. This will allow the medical oncologist to monitor the medical journey of the patient during and up to one month after their chemotherapy. As such, the medical oncologist can finetune the cancer treatment and supportive care measures towards the needs of the patient.

Hypothesis: "An COVID-19 infection will aggravate the severity of the cancer therapy-related complications and thereby diminish the patients' QoL."

Objective 2: Evaluate the patient benefit of digital PROMS platform Rationale: The implementation of a digital PROMs platform for cancer patients has demonstrated multiple benefits in the past, ranging from enhanced patient satisfaction, detection of unrecognized problems, earlier detection of complications, and/or more specific supportive care measures leading to an improved treatment outcome and QoL.

Hypothesis: "The use of a digital PROMs platform for cancer patients undergoing chemotherapy during the COVID-19 pandemic will lead to (1) an improved patient satisfaction and general knowledge on the oncologic supportive care measures and (2) a reduction in patient distress and anxiety".

General approach (for both objectives): A prospective, cohort study will be set up in patients with cancer undergoing chemotherapy. Patients will be stratified during treatment in two groups: (1) COVID-19 positive and (2) negative patients. Patients will be instructed to fill in validated Qol, distress/anxiety, and COVID-19 specific questionnaires via a digital platform from the day of inclusion up to 1-month post-chemotherapy.

An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic

Questionnaire to evaluate the presence and severity of therapy-related side effects

Questionnaire to evaluate patients' health-related quality of life on five different levels

Questionnaire to screen patients for the possibility of a COVID-19 infection.

Questionnaire about symptom burden related to COVID-19

Questionnaire to capture the frequency of specific phobias and stress disorders relevant to COVID-19, including anxiety, depression, specific phobias, cognitive change, avoidance and compulsive behavior, physical symptoms and loss of social functioning

Questionnaire to evaluate their general satisfaction and the user friendliness of the digital platform and how it improved their supportive care

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PBMT for the Management of CIA ( HAIRLASER )	NCT04036994	Breast Cancer Chemotherapy-in... Alopecia	Photobiomodulat...	18 Years -	Hasselt University
The Feasibility of a Physical Activity Intervention for Advanced Multiple Myeloma Patients	NCT04303091	Multiple Myelom... Hematologic Neo... Advanced Cancer	Physical Activi...	18 Years -	University of Calgary
Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction	NCT04979078	Hand-foot Syndr... Hand-foot Skin ...	Photobiomodulat...	18 Years -	Jessa Hospital
An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic	NCT04816656	Covid19 Oncology PROMs Chemotherapeuti...	ePROMs assessme...	18 Years -	Jessa Hospital
PBMT for the Management of CIA ( HAIRLASER )	NCT04036994	Breast Cancer Chemotherapy-in... Alopecia	Photobiomodulat...	18 Years -	Hasselt University

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