Challenge

 Rare Non-specific / Posted 1 year ago

Challenge: A Phase III Study Of The Impact Of A Physical Activity Program On Disease-Free Survival In Patients With High Risk Stage II Or Stage III Colon Cancer: A Randomised Controlled Trial

CHALLENGE aims to determine whether a supervised physical activity (PA) programme in patients with high risk Stage II or Stage III colon cancer will improve 3- year disease-free survival (DFS) in comparison to standard care. The impact on patient-reported outcome measures (PROMS) and quality of life will also be assessed.
There is compelling observational data that PA is associated with colon cancer incidence, recurrence, survival, and quality of life. The trial arms are:
Intervention:
A 36 month structured physical activity programme comprising supervised physical activity sessions and behaviour support sessions and provision of general health education materials (on diet and exercise).
Standard Care:
Provision of general health education materials on diet and exercise only.

  • Inclusion Criteria :
    • Completely resected, histologically-documented, high-risk Stage II or III colon adenocarcinoma.
    • Adjuvant chemotherapy treatment for colon cancer with a 5-flourouracil - based regimen received with the intent to provide a complete course of treatment.
    • Chemotherapy completed (i.e. last dose received) minimum 60 days and maximum 180 days prior to registration.
    • Age of at least 18 years.
    • Completion of the rParQ within 14 days of registration. If responses to any rParQ items are ‘yes’, these items have been discussed with the investigator who has confirmed patient suitable for exercise testing and participation in a physical activity programme.
    • ECOG performance status 0 or 1.
    • Adequate hematological, renal and hepatic function, as defined by the following values, obtained within 49 days of registration: (Absolute neutrophil count (ANC) > 1.0 x 109/L, Platelet count > 100 x109/L, Hemoglobin > 100 g/L, Serum creatinine < 1.5 x UNL, Total bilirubin < 1.5 x UNL, Alkaline phosphatase < 2.5 x UNL, ALT < 2 times UNL, Carcinoembryonic antigen (CEA) < 5ug/L).
    • Completion of baseline imaging (CT chest, and CT/MRI abdomen/pelvis) within 60 days of registration; these tests must not show evidence of metastatic or locally-recurrent colon cancer.
    • Current physical activity levels that do not meet recommended guidelines (> 150 minutes of moderate-to-vigorous or > 75 minutes of vigorous physical activity/week) calculated using the moderate and vigorous components of the LTEQ for physical activity in the month prior to administration
    • Completion of the LTEQ within 14 days of registration to capture pre-diagnosis physical activity participation.
    • Ability (i.e. sufficiently fluent) and willingness to effectively communicate with the Physical Activity Consultant affiliated with the originating cancer centre.
    • Ability (i.e. sufficiently fluent) and willingness to complete the patient-reported outcome questionnaires, social determinants of exercise measurement, health economics and physical activity questionnaires and logs.
    • Able to provide written informed consent.
    • Accessible for treatment and follow-up. Patients registered on this trial must be followed at the participating centre (this includes its affiliated physical activity partner).
  • Exclusion Criteria :
    • Significant co-morbid conditions precluding participation in a physical activity programme as determined by the investigator.
    • Loco-regional or distant metastatic disease at time of registration.
    • Unlikeliness to participate in a physical activity programme, as assessed by the investigator.
    • History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours, Hodgkin’s lymphoma or non-Hodgkin’s lymphoma curatively treated with no evidence of disease for > 5 years.
    • Treatment with any medications deemed by investigator as likely to preclude participation in a physical activity programme.
    • Current treatment with additional chemotherapy or radiation.
    • Inability to complete baseline exercise test done prior to randomisation.
    • Pregnant or planning to become pregnant within the next three years.
    • Prior radiation therapy as a component of treatment for primary tumour.
    • Participants with rectal cancer as determined by the investigator.
  • Study start date : 12/03/2018
  • Study end date : 19/04/2024
  • Principal Investigator : Prof Richard Adams

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