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ANAMORELIN FOR CACHEXIA Series 20 CASE REPORT FORM for... · PDF file Anamorelin for cachexia final CRF 4.7.18 . ANAMORELIN FOR CACHEXIA . Series 20 . ... Palliative Care Phase

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    Anamorelin for cachexia final CRF 4.7.18

    ANAMORELIN FOR CACHEXIA

    Series 20

    CASE REPORT FORM

    Palliative Care Clinical Studies Collaborative (PaCCSC)

    RAPID Pharmacovigilance in Palliative Care

    The case report form (CRF) is to be completed in compliance with PaCCSC Standard Operating Procedures (SOP)

  • 2

    Anamorelin for cachexia final CRF 4.7.18

    Staff email:

    Participant Id:

    Date of Baseline: dd/mm/yyyy

    Demographics

    Gender Male □ Female □ Age ____ years

    Weight (kg)___

    Height (cm)___

    Primary Cancer

    Lung □ Gastric □

    Bowel □ Oesophageal □

    Liver □ Breast □

    Prostate □ Pancreatic □

    Head and Neck □ Other (please specify) □

    Palliative Care Phase

    ⃝ Stable ⃝ Unstable ⃝ Deteriorating ⃝ Terminal

    Stable: The person's symptoms are adequately controlled by established management. Further interventions to maintain symptom control and quality of life have been planned. Unstable Phase: The person experiences the development of a new problem or a rapid increase in the severity of existing problems either of which requires an urgent change in management or emergency treatment. Deteriorating Phase: The person experiences a gradual worsening of existing symptoms or the development of new but expected problems. These require the application of specific plans of care and regular review but not urgent or emergency treatment. Terminal Care Phase: Death is likely in a matter of days and no acute intervention is planned or required.

  • 3

    Anamorelin for cachexia final CRF 4.7.18

    Laboratory tests (Only if

    available)

    Result Not available

    Serum albumin C-Reactive protein (CRP) Blood sugar level Haemoglobin A1C Creatinine Clearance

    Charlson Comorbidity Index

    □ Myocardial infarction

    □ Congestive cardiac failure

    □ Peripheral vascular disease

    □ Cerebrovascular disease

    □ Dementia

    □ Chronic pulmonary disease

    □ Connective tissue disease

    □ Ulcer disease

    □ Mild liver disease

    □ Hemiplegia

    □ Moderate or severe renal disease

    □ Diabetes with end organ damage

    □ Moderate or severe liver disease

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    Anamorelin for cachexia final CRF 4.7.18

    □ AIDS

    □ Diabetes If diabetic please indicate if:

    □ Type I □ Type II

    □ Insulin dependent □ Oral hypoglycaemic agents □ Controlled by diet alone

    How often is BSL monitoring being done?

    □ At least daily □ Less than daily □ No regular monitoring of BSLs.

    Australian Modified Karnofsky Performance Scale (AKPS)

    100 Normal; no complaints; no evidence of disease 90 Able to carry on normal activity; minor signs of symptoms 80 Normal activity with effort; some signs of symptoms or disease 70 Cares for self; unable to carry on normal activity or to do active work 60 Requires occasional assistance but is able to care for most of his needs 50 Requires considerable assistance and frequent medical care 40 In bed more than 50% of the time 30 Almost completely bedfast 20 Totally bedfast and requiring extensive nursing care by professionals and/or family 10 Comatose or barely rousable 0 Dead Not able to determine

  • 5

    Anamorelin for cachexia final CRF 4.7.18

    T0 Baseline Medication Commencement

    Time:

    Estimated weight loss in the past three months: (kgs; patient’s recall)

    Current weight (kgs)

    Weight in kgs:

    % Fat (if available)

    % water ( if available)

    % muscle (if available)

    Anorexia □

    ⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

    NCI Criteria 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition; oral nutritional supplements indicated 3.Associated with significant weight loss or malnutrition (e.g., inadequate oral caloric and/or fluid intake); tube feeding or TPN indicated 4.Life-threatening consequences; urgent intervention indicated 5.Death

    Cachexia □

    ⃝ 1 ⃝ 2 ⃝ 3 ⃝ ungradable ⃝ no symptom ⃝ ungradable

    Fearon and Strasser et al 2011 1.Pre-cachexia-Weight loss /= 5% or BMI 2%; Often reduced food intake/systemic inflammation 3. Refractory cachexia – variable degree of cachexia; Cancer disease both procatabolic and not responsive to anticancer treatment; Low performance score (ECOG/WHO score 3 or 4; less than 3 months survival expected

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    Anamorelin for cachexia final CRF 4.7.18

    Commencement dose Anamorelin

    Dose (mg) Per 24hrs

    Toxicity assessment T0

    Hyperglycaemia/Hypoglycaemia (since last seen) □

    ⃝ Symptomatic hypoglycaemia ⃝ Symptomatic hyperglycaemia

    ⃝ Asymptomatic hyperglycaemia

    Diarrhoea □

    ⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

    NCI Criteria 1.Increase of =7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL 4.Life-threatening consequences; urgent intervention indicated 5.Death

    Other □ – please specify below

    ⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

    Other:

    Additional other □ – please specify below

    ⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

    Additional other:

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    Anamorelin for cachexia final CRF 4.7.18

    Which toxicity/symptom is the most troublesome? Select:

    ⃝ Anorexia ⃝ Cachexia ⃝ Diarrhoea ⃝ Hypoglycaemia/hyperglycaemia ⃝ Other ⃝ Additional other

    Date of next planned visit:

    dd/mm/yyyy

  • 8

    Anamorelin for cachexia final CRF 4.7.18

    T1-Second visit/assessment

    Date of visit/assessment

    dd/mm/yyyy

    T1: Assessed/Not assessed reason

    ⃝ Assessed today (continue)

    ⃝ Died (if died please record below)

    ⃝ Not able to be contacted/located

    ⃝ Too unwell

    ⃝ Other

    Date of Death (dd/mm/yyyy)

    Anorexia □

    ⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

    NCI Criteria 1.Loss of appetite without alteration in eating habits 2.Oral intake altered without significant weight loss or malnutrition; oral nutritional supplements indicated 3.Associated with significant weight loss or malnutrition (e.g., inadequate oral caloric and/or fluid intake); tube feeding or TPN indicated 4.Life-threatening consequences; urgent intervention indicated 5.Death

    Cachexia □

    ⃝ 1 ⃝ 2 ⃝ 3 ⃝ no symptom ⃝ ungradable

    Fearon and Strasser et al 2011 1.Pre-cachexia-Weight loss /= 5% or BMI 2%; Often reduced food intake/systemic inflammation 3. Refractory cachexia – variable degree of cachexia; Cancer disease both procatabolic and not responsive to anticancer treatment; Low performance score (ECOG/WHO score 3 or 4; less than 3 months survival expected

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    Anamorelin for cachexia final CRF 4.7.18

    Current weight (kgs)

    Weight in kgs:

    % Fat (if available)

    % water ( if available)

    % muscle (if available)

    Australian Modified Karnofsky Performance Scale (AKPS)

    100 Normal; no complaints; no evidence of disease 90 Able to carry on normal activity; minor signs of symptoms 80 Normal activity with effort; some signs of symptoms or disease 70 Cares for self; unable to carry on normal activity or to do active work 60 Requires occasional assistance but is able to care for most of his needs 50 Requires considerable assistance and frequent medical care 40 In bed more than 50% of the time 30 Almost completely bedfast 20 Totally bedfast and requiring extensive nursing care by professionals and/or family 10 Comatose or barely rousable 0 Dead Not able to determine

  • 10

    Anamorelin for cachexia final CRF 4.7.18

    Toxicity assessment

    Diarrhoea □

    ⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

    NCI Criteria 1.Increase of =7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL 4.Life-threatening consequences; urgent intervention indicated 5.Death

    Hyperglycaemia/Hypoglycaemia (since last seen) □

    ⃝ Symptomatic hypoglycaemia ⃝ Symptomatic hyperglycaemia

    ⃝ Asymptomatic hyperglycaemia

    Other □ – please specify below

    ⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

    Other:

    Additional Other □ – please specify below

    ⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 ⃝ no symptom ⃝ ungradable

    Additional other:

    Which toxicity/symptom is the most troublesome? Select:

    ⃝ Anorexia ⃝ Cachexia ⃝ Diarrhoea ⃝ Hypoglycaemia/hyperglycaemia ⃝ Other ⃝ Additional other

  • 11

    Anamorelin for cachexia final CRF 4.7.18

    Symptomatic Benefit Assessment Assessed / Not assessed reason ⃝ Assessed