ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001422213

Ethics application status

Approved

Date submitted

21/08/2018

Date registered

27/08/2018

Date last updated

11/02/2021

Date data sharing statement initially provided

30/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Exercise training for cancer survivors with chemotherapy-induced peripheral neuropathy

Scientific title

Exercise rehabilitation for cancer survivors with chemotherapy-induced peripheral neuropathy:
Impact and mechanisms

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chemotherapy-induced peripheral neuropathy

Condition category

Condition code

Cancer

Any cancer

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Home and clinic exercise interventions will be delivered by exercise physiologists affiliated with exercise facilities at each site. Both exercise interventions will consist of three weekly one-hour sessions for 8-weeks. Our experience has indicated that an 8-week exercise program is sufficient to demonstrate intervention benefits while minimising patient attrition. Each one-hour session will be split between cardiovascular, resistance, balance training, and stretching exercises. This design of each session allows the exercise intervention to meet American Cancer Society and American College of Sports Medicine physical activity guidelines for cancer survivors, while also including balance training exercises with demonstrated benefit in smaller studies in a CIPN population. All cardiovascular, resistance, and balance training exercises will be tailored to individual fitness level using a rating of perceived exertion of 13-15/20 (high-moderate intensity exercise). Stretching exercises will be conducted at a more moderate rating of perceived exertion of 10-12/15. Rating of perceived exertion is the selected intensity metric because of its strong correlation to varied objective measures of exercise intensity across exercise modalities, facilitating simple and streamlined prescription and monitoring of intensity without need for equipment both in clinic and at home.

Cardiovascular exercise will be treadmill and outdoor walking or, if patient functional status dictates, stationary cycling in clinic. Resistance training will consist of two sets of 10-15 repetitions of four functional multi-joint movements in each session, two in the upper body and two in the lower body, using dumbbells, Therabands, or exercise machines as appropriate. Patients will be provided with Therabands to enable completion of resistance exercises at home. Balance training exercises will also consist of two sets of four exercises in each session, with two bipedal exercises ((semi-)tandem walking and/or stance)) and two exercises in unipedal stance. Unstable surfaces (i.e. foam mats, pillows) and controlled movements (i.e. torso rotation) will be added as necessary to increase difficulty of balance activities. Resistance and balance training exercise prescriptions will be split into a ‘Session A’ and ‘Session B’ featuring complementary exercises.

Patients will undergo a comprehensive evaluation of initial fitness by an exercise physiologist before beginning their clinic or home exercise program, including screening for a range of comorbidities according to established American College of Sports Medicine guidelines for cancer survivors; as part of this evaluation, a full medical history will be obtained from the medical record for each patient. Patients randomized to the control group and subsequent home intervention will receive a written prescription and demonstration of all home exercises (Session A and Session B) with the frequency, intensity (RPE), time (or number of sets/repetitions) and type of exercises noted and described. Modifications of all exercises to reduce and increase intensity will also be included in the prescription. Exercises will be modified as necessary to facilitate safe completion at home (i.e. tandem walking exercises only prescribed if patient has access to a clear walkway with a wall within arm’s reach). A designated space for patients to record the intensity, time, and type of each exercise performed at each home session will be provided in the form of a patient diary to monitor adherence and compliance to home exercise prescriptions. Follow-up phone calls from the prescribing exercise physiologist in weeks 2 and 5 will be used to monitor the progress of the home intervention, answer patient questions, and monitor the occurrence of any adverse events. Exercise physiologists will also be available to receive calls from patients throughout the duration of the intervention.

Clinic exercise sessions will be delivered in a 1-on-1 or small group format by exercise physiologists. A similar patient diary will be completed by exercise physiologists to monitor patient adherence, compliance and adverse events at clinic-based sessions. Home and clinic exercise diaries will also be used to monitor the fidelity of the prescribed exercises to the established intervention protocol. Additionally, diaries of home and clinic-based exercise sessions will be utilised to guide the progression of exercises throughout the intervention; RPE will be recorded for each exercise at all sessions, and a recorded RPE below 13 for an exercise will indicate a modification to that exercise to increase intensity (i.e. increased resistance for resistance training exercises; addition of unstable surface and/or upper body movement for balance training exercises; increased speed, incline or resistance for cardiovascular exercise). Modifications of exercise intensity will be guided by exercise physiologists in clinic and written exercise prescriptions at home. Phone calls from the prescribing exercise physiologist during home interventions will further assist with appropriate progression of exercise intensity.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

The control treatment is 8-weeks without formal exercise intervention. The control group will be prescribed a home-based exercise intervention following the 8-week control period.

Control group

Active

Outcomes

Primary outcome [1]

Total Neuropathy Score (clinical version)

Timepoint [1]

Baseline, 8-week assessment (primary endpoint), 16-week assessment, 6-month follow up

Secondary outcome [1]

Patient reported-neuropathy -- EORTC CIPN-20

Timepoint [1]

Baseline, 8-week assessment, 16-week assessment, 6-month follow-up

Secondary outcome [2]

Quality of Life -- SF-36

Timepoint [2]