Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B2342020000029 | Registry Identifier | Belgian Registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hasselt University | OTHER |
Not provided
Not provided
Not provided
Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. 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. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.
This aim of this study is to determine the efficacy of PBMT in combination with the institutional therapy on the management of BCRL. Therefore, we hypothesize that PBMT in combination with manual lymphatic drainage is able to reduce the limb circumference and the associated pain and improve the QoL of patients with BCRL during treatment and up to 12 months post-treatment.
Primary Objective 1: Arm circumference
The study seeks primarily to determine the effectiveness PBMT and manual lymphatic drainage in reducing the arm circumference in patients with established BCRL during PBM treatment and up to 12 months post-PBMT.
Primary Objective 2: Activity and participation
Another primary aim of this study is to evaluate the effectiveness of PBMT and manual lymphatic drainage in the enhancement of the patients' activity and participation status.
Secondary Objective 1: Pain
A secondary aim of this study is to evaluate if PBMT and manual lymphatic drainage can reduce the BCRL-related pain during PBM treatment and up to 12 months post-PBMT.
Secondary Objective 2: Quality of life
A secondary aim of this study is to evaluate if PBMT and manual lymphatic drainage can improve the patients' QoL during PBM treatment and up to 12 months post-PBMT.
Secondary Objective 3: Depression
A secondary aim of this study is to evaluate if PBMT and manual lymphatic drainage can improve the patients' mental status during PBM treatment and up to 12 months post-PBMT.
Secondary Objective 4: Patient satisfaction
A secondary aim of this study is to evaluate if patients are satisfied with PBMT and manual lymphatic drainage as a treatment for BCRL during the treatment sessions and up to 12 months post-therapy.
Secondary Objective 5: PBM safety
A secondary aim of this study is to evaluate the safety of PBM in oncologic patients up to 5 years post-PBMT.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Group A will receive first PBM + manual lymphatic drainage for 9 weeks (2 sessions/week), followed by 9 weeks only manual lymphatic drainage. |
|
| Group B | Active Comparator | Group B will first receive only manual lymphatic drainage for 9 weeks, followed by the combination of PBM and manual lymphatic drainage for 9 weeks (2x/week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation therapy (PBMT) | Device | The MLS M6 laser from ASA will be used to apply the laser therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12Ï€ C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter | Baseline |
| Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12Ï€ C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter | week 5 |
| Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12Ï€ C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter | week 9 |
| Arm circumference and volume |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | Baseline |
| Pain assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jolien Robijns, PhD | Contact | 011337229 | jolien.robijns@jessazh.be |
| Name | Affiliation | Role |
|---|---|---|
| Jeroen Mebis, MD, PhD | Jessa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasselt University | Recruiting | Hasselt | Limburg | 3500 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000072656 | Breast Cancer Lymphedema |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D000073297 | Manual Lymphatic Drainage |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D008405 | Massage |
| D064746 |
Not provided
Not provided
prospective randomized, controlled cross-over trial
Not provided
Not provided
Single : outcome assessor
| Manual Lymphatic drainage | Procedure | Patients will receive twice weekly MLT executed by trained physiotherapist |
|
|
The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm.
The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12Ï€ C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter
| Week 14 |
| Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12Ï€ C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter | Week 18 |
| Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12Ï€ C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter | 3 month follow-up |
| Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12Ï€ C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter | 6 month follow-up |
| Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12Ï€ C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter | 9 month follow-up |
| Arm circumference and volume | The arm circumferences will be measured at olecranon and at 4, 8, 12, 16 and 20 cm proximal and distal of olecranon. The circumference at each point will be recorded in cm. The calculated arm volume will be estimated by the formula of the truncated cone of each 4 cm segment proximal (towards the wrist) and distal (towards the acromion) from the olecranon. The following truncated cone formula was used: 4 * (C1* C1 +C1*C2+C2*C2)/12Ï€ C1 is the upper circumference and C2 is the lower circumference of each segment. The calculated volume of whole arm is the sum of the volume of all segments of the arm expressed in kubic centimeter | 12 month follow-up |
| Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | Baseline |
| Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | week 5 |
| Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | week 9 |
| Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | week 14 |
| Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | week 18 |
| Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | 3 month follow-up |
| Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | 6 month follow-up |
| Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | 9 month follow-up |
| Arm mobility measurement | A standard plastic goniometer will be used to measure active range of mobility (ROM) for shoulder flexion, abduction, and external rotation. | 12 month follow-up |
| Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. | Baseline |
| Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | week 5 |
| Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | week 9 |
| Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | week 14 |
| Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | week 18 |
| Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | 3 month follow-up |
| Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | 6 month follow-up |
| Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | 9 month follow-up |
| Activity and participation | The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. The score can range from 0 (no disability) to 100 (most severe disability). | 12 month follow-up |
| ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | Baseline |
| ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | Week 9 |
| ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | Week 18 |
| ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | 3 month follow-up |
| ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | 6 month follow-up |
| ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | 9 month follow-up |
| ISL classification | The severity of BCRL will be evaluated using the ISL criteria. This will be performed by the treating physician. | 12 month follow-up |
The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony).
| week 5 |
| Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | week 9 |
| Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | week 14 |
| Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | week 18 |
| Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | 3 month follow-up |
| Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | 6 month follow-up |
| Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | 9 month follow-up |
| Pain assessment | The patients will be asked to evaluate their pain related to BCRL by using the Visual Analogue Scale (VAS). This scale ranges from 0 (no pain at all) to 10 (extreme agony). | 12 month follow-up |
| Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | Baseline |
| Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | week 5 |
| Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | week 9 |
| Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | week 14 |
| Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | week 18 |
| Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | 3 month follow-up |
| Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | 6 month follow-up |
| Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | 9 month follow-up |
| Quality of life assessment | The validated Lymphedema Functioning, Disability, and Health questionnaire for the upper limb (Lymph-ICF-UL) will be used to evaluate the patients' QoL. This scale ranges from 0 (no problem at all) to 100 (very severe problem). | 12 month follow-up |
| Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | Baseline |
| Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | week 5 |
| Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | week 9 |
| Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | week 14 |
| Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | week 18 |
| Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). | 3 month follow-up |
| Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | 6 month follow-up |
| Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | 9 month follow-up |
| Depression, anxiety and stress | The mental health of the patients will be determined using the Depression Anxiety Stress-Scale (DASS-21). Three different scores will be calculated: depression (0-21), anxiety (0-21) and stress (0-18). A lower score indicates a normal mental health, while a higher score indicates extremely severe depression, anxiety and/or stress. | 12 month follow-up |
| Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). | At week 9 |
| Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). | At week 18 |
| Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). | 3 month follow-up |
| Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). | 6 month follow-up |
| Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). | 9 month follow-up |
| Patients' satisfaction with the therapeutic intervention | The patients will be asked to evaluate the general pleasantness and soothing effect of the therapeutic intervention and their global satisfaction with the therapeutic intervention, using the Numerical Rating Scale (NRS). This is scored on a scale from 0 (extremely dissatisfied) to 10 (extremely satisfied). | 12 month follow-up |
| 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). | 3 month follow-up |
| 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). | 6 month follow-up |
| 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). | 9 month follow-up |
| 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). | 12 month follow-up |
| Appearance and date of local and regional recurrence | The possible appearance and date of local and/or regional recurrence will be collected. | 12 month follow-up |
| Appearance and date of local and regional recurrence | The possible appearance and date of local and/or regional recurrence will be collected. | 2 years follow up |
| Appearance and date of local and regional recurrence | The possible appearance and date of local and/or regional recurrence will be collected. | 3 years follow up |
| Appearance and date of local and regional recurrence | The possible appearance and date of local and/or regional recurrence will be collected. | 4 years follow up |
| Appearance and date of local and regional recurrence | The possible appearance and date of local and/or regional recurrence will be collected. | 5 years follow up |
| Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 1 year follow up |
| Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 2 years follow up |
| Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 3 years follow up |
| Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 4 years follow up |
| Appearance and date of secondary tumors | The possible appearance and date of secondary tumors will be collected. | 5 years follow up |
| Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 1 year follow up |
| Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 2 years follow up |
| Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 3 years follow up |
| Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 4 years follow up |
| Appearance and date of distant metastasis | The possible appearance and date of distant metastasis will be collected. | 5 years follow up |
| Date of death of any cause | If the patient dies within the first year after the treatment, their date of death will be collected. | 1 year follow up |
| Date of death of any cause | If the patient dies within 2 years after the treatment, their date of death will be collected. | 2 years follow up |
| Date of death of any cause | If the patient dies within 3 years after the treatment, their date of death will be collected. | 3 years post treatment |
| Date of death of any cause | If the patient dies within 4 years after the treatment, their date of death will be collected. | 4 years follow up |
| Date of death of any cause | If the patient dies within 5 years after the treatment, their date of death will be collected. | 5 years follow up |
| Jessa Ziekenhuis | Recruiting | Hasselt | Limburg | 3500 | Belgium |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D004322 | Drainage |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |