Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202001542824141 Date of Approval: 28/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of 6-week pedometer-based physical activity lifestyle on physical activity level, body composition and superoxide dismutase in breast cancer survivors: a randomized controlled trial
Official scientific title Effects of 6-week pedometer-based physical activity lifestyle on physical activity level, body composition and superoxide dismutase in breast cancer survivors: a randomized controlled trial
Brief summary describing the background and objectives of the trial Cancer is initiated by cumulative genetic and epigenetic changes to a normal cell (Prendergast et al., 2010), resulting in an abnormal growth of cells, which tend to proliferate in an uncontrolled way and, in some cases, to metastasize (spread to other parts of the body. While oncogenesis initiates cancer modifier effects, exerted by the tissue microenvironment, guide progression. For instance, a wide variety of immune cells in the inflammatory microenvironment can contribute significantly to tumour suppression. Yet it is also evident that tumours can evolve tactics to ‘tilt’ the immune balance from being antagonistic to supportive (Prendergast et al., 2010). Thus, the balance between immunosuppressive and immunostimulatory signals in the inflammatory microenvironment has profound implications for tumour eradication, control (dormancy), or outgrowth. Currently, there is evidence of exercise-induced changes in the activity of macrophages, natural killer cells, lymphokine-activated killer cells, neutrophils, and regulating cytokines. These suggest that anti-inflammatory and immunomodulation may contribute to the protective value of exercise (Shepard & Shek, 1995; Duman et al., 2008,). Invariably, physical activity should also have implications in this context for surrogate markers of cancer prevention. Based on the above facts, it is proposed in this study that surrogate markers of cancer prevention may vary in patients with breast cancer compared to apparently healthy females who are age-matched, depending on their physical activity level; and that physically-active lifestyle modifications using pedometer will have the same effects in both groups. This study seeks to determine the effects of 6-week pedometer use on superoxide dismutase and body composition in patients with breast cancer and age-matched apparently healthy females.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 27/07/2016
Actual trial start date 11/09/2016
Anticipated date of last follow up 26/07/2018
Actual Last follow-up date 18/09/2019
Anticipated target sample size (number of participants) 98
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Physical activity intervention Six weeks The primary intervention comprised of 2 components delivered over a 6‐week period - 1) Behavioural feedback and goal‐setting session: Physical activity consultations, behavioural feedback and goal‐setting sessions were held with the participants to address the barriers to physical activity using The Trans-Theoretical Model (TTM) throughout the study duration. Personalized strategies from the goal-setting sessions included: enhancing motivation, overcoming barriers and developing appropriate walking plans. Goals were retained for one week to enable participants to reinforce their increased levels of walking or to try other strategies to successfully accumulate the additional steps. Participants were advised on the nature of the intensity and duration of the desired increases in walking. Participants were familiarized with the Borg 6–20 scale and advised that additional walking should be of a brisk nature that would leave them slightly breathless and hot, but still able to talk (indicated as between 12–14 on this scale). Bouts of at least 10 minutes in duration were advised for additional walking, although the accumulation of walking during everyday tasks as much as possible was also be advocated. 2) Wearable technology: Participants in the Intervention (pedometer) group were provided with pedometers which they wore on their wrist. The pedometer step counts/day was measured with the FitbitCharge HR. 40
Control Group Usual activity Six weeks Participants assigned to the control (no-pedometer) group were asked to maintain their normal physical activity level/walking behaviour between baseline and week six. They were advised to continue their current management program. 40 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
To be eligible to participate in this trial, women were: i. diagnosed with breast cancer, ii. aged 18 – 60 years, iii. ambulated independently, iv. were not on sedatives at least 4 weeks prior to the study v. Had no history of hypertension vi. Staging of breast cancer was within stages I - III according to SEER stage of disease classification vii. were never-smokers viii. were on primary treatment (chemotherapy, radiotherapy surgery) for ≤2 months ix. without a visual loss. Participants were excluded if they had a history of other underlying pathological diseases of metabolic, orthopaedic or neurological nature. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/06/2017 University of Nigeria Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Ituku-Ozalla, PMB 01129 Enugu 23401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Physical activity Baseline and at six-weeks
Secondary Outcome Body composition/anthropometry Baseline and at six weeks
Secondary Outcome Serum level of Superoxide dismutase Baseline and at six weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Oncology Clinic at the University of Nigeria Teaching Hospital Enugu Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Hannover University Hannover Hannover Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hannover University Hannover Hannover Germany University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sam Ibeneme sam.ibeneme@unn.edu.ng +2347038138435 University of Nigeria
City Postal code Country Position/Affiliation
Enugu Nigeria Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Amarachi Ezuma amarachiezuma@gmail.com +2347038138435 University of Nigeria
City Postal code Country Position/Affiliation
Enugu Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Emmanuel Ezeome emmanuel.ezeome@unn.edu.ng +2348033083495 University of Nigeria, Enugu
City Postal code Country Position/Affiliation
Enugu Nigeria Consultant surgeon
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participants de-identified data collected will be made available upon request for research purposes. Study Protocol The data will be made available between 6 months and 5 years following the publication of the article. Researchers with an intent to use the de-identified data will be required to submit a research proposal approved by an independent review committee. The researchers will need to sign a data access agreement form and all inquiries should be directed to Dr Sam Ibeneme (sam.ibeneme@unn.edu.ng).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information