Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Alopecia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJessa Hospital

About this trial

This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the prevention and management of chemotherapy-induced alopecia (CIA). Therefore, we hypothesize that PBMT can reduce the severity of CIA in gynecological and breast cancer patients, increasing the patient's QoL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with gynecological cancer (endometrium, cervix, ovarian or vulva) or breast cancer

Receiving chemotherapy ((Carbo)-Taxol)

Age ≥ 18 years

Able to comply to the study protocol

Disqualifiers

Metastatic disease

Pregnancy

Active infection of the scalp

Previous diagnosis of a hair loss condition

Trial design

Design model

Parallel

Treatments tested in this trial

  • Theradome® LH80 pro

    Device

    The Theradome LH80 pro is a wearable laser helmet device, which uses red laser light to stop hair loss, thicken existing hair and stimulate the growth of new hair.

  • Scalp cooling

    Device

    Scalp cooling is a standard treatment that is applied to prevent hair loss during chemotherapy.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hair thickness measurement

The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.

Time frame
Baseline
2

Hair thickness measurement

The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.

Time frame
Halfway into their chemotherapy (An average of 6 weeks)
3

Hair thickness measurement

The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.

Time frame
At the final chemotherapy session (An average of 12 weeks)
4

Hair thickness measurement

The research assistant will objectively evaluate the thickness of the hair using a micrometer screw gauge.

Time frame
One month post chemotherapy

Secondary outcomes

1

Quality of life score

The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.

Time frame
Baseline
2

Quality of life score

The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.

Time frame
Halfway into their chemotherapy (An average of 6 weeks)
3

Quality of life score

The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.

Time frame
At the final chemotherapy session (An average of 12 weeks)
4

Quality of life score

The European Organization for Research and Treatment for Cancer Quality of Life Questionnaire will be used to evaluate the patients' quality of life.

Time frame
One month post chemotherapy

Other outcomes

1

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

General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).

Time frame
Baseline
2

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

General and medical information will be collected through a short patient questionnaire in order to assess intrinsic risk factors (e.g. age and smoking history). Information regarding the disease- and treatment-related risk factors will be collected through medical records (e.g., tumour type and stage).

Time frame
One month post chemotherapy
3

Cancer relapse or recurrence

The posibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

Time frame
One year post chemotherapy
4

Cancer relapse or recurrence

The possibility of cancer relapse or recurrence will be evaluated using the patients' medical records.

Time frame
Two years post chemotherapy

Sponsors and contacts

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