Randomised Controlled Clinical Trial of a Supervised EXErcise Program in Patients with Lymphoma treated with Chemotherapy

• Conditions: ymphoma; Lymphoma; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma; Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

• Registration Number: ACTRN12615000085572
• Lead Sponsor: Dr Fernando Roncolato

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-02
• Study Completion: 2017-06-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients with all of the following criteria will be eligible for enrolment:
a) Aged between 18 and 80 years with biopsy-proven diagnosis of lymphoma, both Hodgkin and non-Hodgkin.
b) Recommended to have systemic chemotherapy with or without external beam radiotherapy, with curative intent.
c) Need to have at least half of their recommended number of chemotherapy treatment cycles remaining.
d) ECOG level 0-2 with adequate cardio-respiratory and musculoskeletal function to participate in a regular exercise program as determined by the consultant physician/investigator.
e) Ability to read and understand the Patient Information Document and Consent Form with provision of verbal and written consent. Willingness and ability to comply with the specified intervention protocol, follow-up visits and all necessary investigations.

Exclusion Criteria

Patients with any of the following criteria are not eligible for enrolment:
a) Recommended to either observation or chemotherapy with palliative intent.
b) Psychiatric disorders which impair ability to give verbal and written consent.
c) ECOG level 3-4

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient reported health related quality of life as assessed by EORTC QLC C-30, HADS, Fact-An, FACT-C, FSFI and IIEF<br><br>[Baseline, 6 weeks, 12 weeks, 6 months, 12 months.]

Secondary Outcome Measures

Name	Time	Method
Deliverability of chemotherapy as assessed by scheduled and actual completion of prescribed chemotherapy dose and schedule.[At end of chemotherapy treatment.];Emotional well-being, including mood at the completion of the structured exercise program, as assessed by EORTC QLC C-30, HADS, Fact-An, FACT-C, FSFI and IIEF Patient reported health related quality of life tools.[Completion of exercise program]