An interventional study of rehabilitation in Breast Cancer, sponsored by King Fahad Medical City. Completed at 1 site in Saudi Arabia. Open to female participants. Per ClinicalTrials.gov, last updated 2021-05-24.
Sponsored by King Fahad Medical City · Not applicable, Interventional, and Prevention
Among 52 studies in Breast Neoplasms with a site in Saudi Arabia — 8 open to participants now, 15 under way, 9 of them phase 3. Breast Neoplasms · Saudi Arabia.
Among the 52 studies in Breast Neoplasms with a site in Saudi Arabia, this one is the 34th largest by enrollment of the 35 interventional ones that give a count, is one of 2 that started in 2018, is one of 7 with no phase, and was the 36th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 23 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →8 of the 52 studies in Breast Neoplasms with a site in Saudi Arabia are open now.
A study can be open while its sites in Saudi Arabia have not opened yet or have stopped. Only those recruiting at a site in Saudi Arabia →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: female · no healthy volunteers.
The full table on the hub →52 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 6 · Phase 3 21
First in 2001; this study’s year is marked. 2 started in 2018.
Median enrollment 491 across the 35 interventional studies, 185 across the 17 observational. Of the 29 that completed or were terminated, 13 (45%) have results posted.
28 of 52 have an industry lead sponsor. The 10 most frequent:
King Fahad Medical City is the lead sponsor of 22 studies on the registry; none are open to participants now.
King Fahad Medical City has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
2 of the studies in Breast Neoplasms with a site in Saudi Arabia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04784715Phase 3AstraZenecaTrastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | 2027-05-03 |
| NCT07811635Jinnah Postgraduate Medical CentrePRISM Trial: Partial Breast Versus Whole Breast Radiation in Early Breast Cancer | 2026-12-31 |
Among the 52 studies in Breast Neoplasms with a site in Saudi Arabia, from their registry updates:
pilot study on physical therapy in women with breast cancer immediately following surgery
A pilot, single-arm non-randomized clinical trial was conducted between the period September 2018 and June 2019 on a convenient sample of BC women. Primary study outcomes were pain, disabilities of the Arm, Shoulder, and Hand (DASH), handgrip strength, and quality of life (QoL). The secondary outcome was to assess the feasibility of this pilot study. All outcomes were recorded at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90) under standardized conditions. The interventions were delivered by the physiotherapist early within 24 hours post-operatively, T1, and T2. In addition, home-based exercise was provided with written instructions during hospitalization with rehearsal sessions to ensure the patient's understanding and compliance
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
effect of rehabilitation program in the intervention arm
Procedure: rehabilitation
physical therapy 24 hrs after surgery
Shoulder/Arm Pain
Pain in the shoulder/arm was assessed using the visual analogue scale (VAS) with a scoring system of 0-10 (0 = no pain; 1-3; mild pain, 4-6; moderate pain, 7-10 severe pain)
Time frame: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Shoulder mobility
Shoulder mobility (flexion \[0-180°\], abduction \[0-180°\]) was measured by using a digital inclinometer under standardized conditions. Patients were maintained in a seated position for all movements to minimize compensatory movements of the trunk.
Time frame: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Disabilities in daily life
by using Quick DASH scale (Disabilities of the Arm, Shoulder, and Hand) questionnaire. The Quick DASH consists of 11 items that allow for cumulative and multiple assessments of a patient over time, and each item has 5 response options. According to the Quick DASH scale scoring system, the scale scores are calculated and ranging from 0 (no functional disability) to 100 (most severe disability)
Time frame: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Handgrip strength
measured while the patient stabilized in a seated position with the elbow in 90 degrees of flexion and squeezes three times the dynamometer with each hand.
Time frame: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Quality of Life (QoL)
Patients' QoL was assessed by using the Functional Assessment of Cancer Therapy-General (FACT-G) scale. FACT-G (version-4) is a validated, self-reported multi-dimensional, 27-items questionnaire measuring QoL for breast cancer patients with 1 4-points Likert scale (0-108). The FACT-G comprises of 4-subscales: Physical Well-being (PWB: 7-items; score range 0 to 28), Social Well-being (SWB: 7-items; score range 0 to 28), Emotional Well-being (EWB: 6-items; score range 0 to 24), Functional Well-being (FWB: 7-items; score range 0 to 28)
Time frame: The measurements of the study outcomes took place at three time- intervals (T0=day 1 post-operation), (T1=day 30), and (T1=day 90).
Establishing firmly study feasibility
Assess for clinical effect size (ES) worth investigation, sample recruitment strategy, adherence to study protocol, and adverse events in preparation to conduct a larger definitive study.
Time frame: 3 months
Ran from Sep 2018 to primary completion in Jun 2019, 9 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 9 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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King Fahad Medical City