Clinical trial NCT01921998: Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy
Official title: Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Lymphoma
Sarcoma
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%.

Brief summary: Side effects from chemotherapy can be severe in some patients leading to admission to hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood test that could predict patients who will go on to develop severe side effects could be useful and might allow early intervention with medicines to reduce the severity of the symptoms and prevent admission to hospital.

This study will collect blood samples from patients with lymphoma or sarcoma who are receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the side effects that most commonly results in hospital admission, of less than 20%). It will assess whether changes in blood proteins ("biomarkers") taken 2 days after the 1st chemotherapy can predict subsequent severe side effects throughout the 4 months of chemotherapy. In addition the investigators will collect data on quality of life and contact with medical professionals to assess the costs of chemotherapy toxicity to both the patient and health service. This will allow us in the future to model the cost effectiveness of using biomarkers in this manner to try and reduce chemotherapy toxicity.


Eligibility criteria: Inclusion Criteria:

* Patients with lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%. This would include 21 day R-CHOP in patients under 70 and single agent doxorubicin \[Aapro et al, 2011a\].
* Age 18 or older
* Performance Status 0-2
* Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.

Exclusion Criteria:

* Past history of HIV, Hepatitis B or C positive, due to the difficulties in handling high-risk specimens within CEP.
* Major surgery, radiotherapy, chemotherapy or mechanism based agents within the last 4 weeks.
* Radio-immunotherapy within the last 8 weeks.
* Bilirubin greater than 1.5 X the upper limit of normal and ALT greater than 2.5 x the upper limit of normal (as disturbed liver function tests are associated with elevated CK18) \[Gonzalez-Quintela et al, 2009, Lavallard et al, 2011\]
* Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Primary outcomes:
measure: sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity
timeFrame: day 3
Secondary outcomes:
measure: number of hospital admissions for febrile neutropenia
timeFrame: end of chemotherapy at approximately 6 months
measure: Total number of overnight stays or stays in A&E of over 4 hours spent in hospital
timeFrame: End of study chemotherapy at approximately 6 months
measure: Dose intensity of chemotherapy achieved compared to planned cumulative dose on initiation of therapy
timeFrame: End of chemotherapy at approximately 6 months
measure: Number of total days delay in receiving chemotherapy treatment compared to planned delivery
timeFrame: end of chemotherapy at approximately 6 months
measure: Change in QOL at the start of cycles 2, 4 and 6 of chemotherapy and at the end of study as measured by functional assessment of cancer therapy general (FACT-G) and euroqol EQ-5D questionnaires
timeFrame: cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months)
measure: Total number of contacts (both face to face and telephone) with medical and nursing staff including visits to GP, Accident and Emergency, hospital clinics and telephone consultations with Hotline staff of hospital doctors
timeFrame: end of study chemotherapy at approximately 6 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Alastair Greystoke
role: STUDY_CHAIR
References: