Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy (BioACT)

The Christie NHS Foundation Trust

Status: Suspended

Conditions: Sarcoma; Lymphoma

Treatments: Procedure: Biomarker and health economics

Study type: Observational

Funder types: Other

Identifiers

NCT01921998

11_DOG05_99

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Biomarker and health economics

Description:

Biomarkers will be taken throughout cycle 1. Health economics will be recorded using a patient side effect diary, a details of admission form, and a patient survey of healthcare use.

Treatment:

Procedure: Biomarker and health economics