Chemotherapy Induced Peripheral NeuropathyNCT06696976
Effects of Telerehabilitation Versus Clinical Rehabilitation on Chemotherapy Induced Peripheral Neuropathy
A study testing Telerehabilitation and Clinical rehabilitation in people with Chemotherapy Induced Peripheral Neuropathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to determine the comparative effects of telerehabilitation versus clinical rehabilitation on neuropathic pain, physical function and quality of life in Chemotherapy induced peripheral neuropathy patients. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy
- What is being tested?
- Telerehabilitation and Clinical rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2024to 31 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with breast cancer.
- Patients of age between 45 to 75years.
- Patient expected to survive for 6 month or more.
- Patient after specific chemotherapy such as taxanes(paclitaxel),vinca alkaloids(vinorelbine),bortezomib, lenalidomide and platinum-based.
- Patient with Stage 1 to 3.
- Patients have prior history of mechanical nerve entrapment without clinical symptoms (carpal tunnel syndrome) were included.
- Patient who sustained grade 3 and 4 of European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20).
Who cannot join
- Patients with history of peripheral neuropathy.
- Participants are excluded if they had comorbid conditions causing peripheral neuropathic symptoms (including previous chemotherapy or diabetes or alcohol abuse and non-alcoholic liver diseases.
- Patients not scheduled for one of the aforementioned taxane-based regimens.
- Patients with vitamin D or B12 deficiency.
- Non-ambulatory Patients.
- Patients reluctant to practice exercise program.
- Patient have impaired visual or vestibular system and presence of bone or any kind of central nervous system involvement , including cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54660
Muhammad Kashif, Phd, 03333125303, kashif.shaffi@riphah.edu.pk
About this study
Official title: Effects of Telerehabilitation Versus Clinical Rehabilitation on Neuropathic Pain, Physical Function and Quality of Life in Chemotherapy Induced Peripheral Neuropathy
The aim of this study is to determine the comparative effects of telerehabilitation versus clinical rehabilitation on neuropathic pain, physical function and quality of life in Chemotherapy induced peripheral neuropathy patients.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is among the most prevalent and debilitating adverse effects of cancer treatment. CIPN increase risk of falls and impair physical function and quality of life (QOL). Physical therapy improves the CIPN symptoms, quality of life and physical function in cancer patients after chemotherapy. Telerehabilitation technologies such as telephone and video conferencing, have the capability of bringing services into the survivors' home and manage the symptoms without needing to have direct physical contact with the hospital or clinic services. The aim of this study is to determine the comparative effects of telerehabilitation versus clinical rehabilitation on neuropathic pain, physical function and quality of life.
This study will be a randomized clinical trial that will conducted at Gujranwala institute of Nuclear Medicine hospital in which sixty-six cancer patient who will sustain grade 3 and grade 4 of European Organization for Research and Treatment of Cancer Quality of life-Chemotherapy Induced Peripheral Neuropathy Questionnaire (EORTC-QLQ-CIPN20)will randomly allocated to Group A(n=33)who will receive Telerehabilitation and Group B (n=33) who will receive clinical rehabilitation using the computer generated method. The sample size calculated for this trial will be 66. Interventions will be given in both groups for 60 minutes for 12 weeks (3times per week).10 minutes for Nerve Gliding exercises ,20 minutes for Balance training and 20 minutes forResistance training (using Therapeutic band).European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20) will be used to assess quality of life. Berg balance scale for balance and Manual Muscle testing for muscle strength. The data will be entered and analyzed using SPSS 26. Statistical significance will be set at p=0.05. Normality of data will be assessed through Kolmogorov-Smirnov test. Assessment will be carried out at baseline,6th week, 12th week after discontinuation of treatment and 18th week follow up. For between group analysis of parametric data Independent T test will be used, while Mann Whitney test will be applied for non-parametric data. For within group comparison repeated measure ANOVA will be used, for non-parametric data, Friedman ANOVA will be applied.
- Being tested
- Telerehabilitation, Clinical rehabilitation
- Keywords
- Chemotherapy induced peripheral neuropathy, Telerehabilitation, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
A qualified physiotherapist himself used the digital platform Zoom (Zoom Video Communications or WhatsApp video communication) to deliver synchronic online sessions (60 min each), sending each participant a link by email, half an hour before the weekly meetings. The patients were also invited to present themselves in comfortable gymnastic clothing and with tools useful for the motor program: a chair, a stick, a bottle full of water (or small weights if the patient had them), and a mat.
Nerve gliding exercises: These 5 Nerve gliding exercises will perform 3 times a week requiring 10 minutes to complete.
Balance exercises: Balance exercise include 10 exercises and take 20 minutes of completion, 2minute for each exercise.
Resistance training using Thera Band will performed with the presence of the researcher as an instructor.The main upper-extremity movements consisted of chest press, shoulder press etc and in lower extremity such as leg press ,back thgh press etc. in patient.
Clinical rehabilitationOther
A qualified physiotherapist himself used the digital platform Zoom (Zoom Video Communications or WhatsApp video communication) to deliver synchronic online sessions (60 min each), sending each participant a link by email, half an hour before the weekly meetings. The patients were also invited to present themselves in comfortable gymnastic clothing and with tools useful for the motor program: a chair, a stick, a bottle full of water (or small weights if the patient had them), and a mat.
Nerve gliding exercises: These 5 Nerve gliding exercises will perform 3 times a week requiring 10 minutes to complete.
Balance exercises: Balance exercise include 10 exercises and take 20 minutes of completion, 2minute for each exercise.
Resistance training using Thera Band will performed with the presence of the researcher as an instructor.The main upper-extremity movements consisted of chest press, shoulder press etc and in lower extremity such as leg press ,back thgh press etc. in patient.
| Study group | Role | What they receive |
|---|---|---|
| Group A (telerehabilitation of neuropathic pain, physical function and quality of life) | Experimental | Group A will receive Telerehabilitation of 60 minutes with short resting intervals .Treatment will be given 3 times per week for 12 weeks.
1. warm up of 5 minutes
2. Nerve gliding exercises of 10 minutes
3. Balance exercises of 20 minutes
4. Resistance training of 20 minutes
5. cold down of 5 minutes Receives: Other: Telerehabilitation |
| Group B (clinical rehabilitation of neuropathic pain, physical function and quality of life) | Experimental | Group B will receive Clinical rehabilitation of 60 minutes with short resting intervals .Treatment will be given 3 times per week for 12 weeks.
1. warm up of 5 minutes
2. Nerve gliding exercises of 10 minutes
3. Balance exercises of 20 minutes
4. Resistance training of 20 minutes
5. cold down of 5 minutes Receives: Other: Clinical rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
NUMERIC PAIN RATING SCALE
Numeric Pain Rating Scale (NPRS) rated CIPN pain. The NPRS is an 11point scale (0-10) ranking pain from 0, indicating no pain at all, to 10, indicating worst pain imaginable on each assessment visit, of the finger tips. This was to identify pain specific to CIPN. A change score of 2 is reported to be a clinically relevant change. The numeric pain rating scale was used for pain measurement , the reliability of which is reported to be between 85% and 95%.
Measured: 12th week
EORTC CIPN20
The EORTC CIPN20 should provide valuable information on CIPN-related symptoms and functional limitations of patients exposed to potentially neurotoxic chemotherapeutic and/or neuroprotective agents. The resulting 20-item questionnaire was pre-tested in three languages and four countries and is currently being examined in a large, international clinical trial. The Chinese version of the EORTC QLQ-CIPN20 demonstrated acceptable reliability, validity and responsiveness and was found comparable in measuring CIPN among Chinese cancer patients.The questionnaire consists of sensory and motor neuropathy scales, autonomic scales for dizziness, blurred vision, and erectile dysfunction. The results obtained were converted into a 0-100 scale, with higher results indicating a higher degree of peripheral neuropathy.
Measured: 12th week
The Berg balance scale (BBS):
Is considered the criterion standard in functional balance evaluation. In total, 14 different activities are scored between 0 (worst) and 4 (best), according to the patient's performance. The maximum score is 56. A total score close to 56 indicates that the balance of the patient is good, and lower scores denote poor balance established the validity and reliability of the Turkish version of the BBS.
Measured: 12th week
Manual Muscle testing (MMT)
Is the most commonly used method for documenting impairments in muscle strength. Because of the variability possible during MMT, several studies examining MMT have used specialized instrumentation to provide support for the extremity tested and for standardization of joint position. Throughout its history manual muscle testing has been performed by practitioners' hands. Lamb states (1985) that MMT has content validity because the test construction is based on known physiologic, anatomic and kinesiologic principles. A number of research papers have dealt with this specific aspect of MMT in the diagnosis of patients.
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start20 Nov 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Phd, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696976
- Sponsor's protocol ID
- REC/RCR&AHS/24/0229
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.
PubMed 15911236Cheville AL, Moynihan T, Herrin J, Loprinzi C, Kroenke K. Effect of Collaborative Telerehabilitation on Functional Impairment and Pain Among Patients With Advanced-Stage Cancer: A Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):644-652. doi: 10.1001/jamaoncol.2019.0011.
PubMed 30946436Loubani K, Schreuer N, Kizony R. Telerehabilitation for Managing Daily Participation among Breast Cancer Survivors during COVID-19: A Feasibility Study. J Clin Med. 2022 Feb 16;11(4):1022. doi: 10.3390/jcm11041022.
PubMed 35207294van Egmond MA, Engelbert RHH, Klinkenbijl JHG, van Berge Henegouwen MI, van der Schaaf M. Physiotherapy With Telerehabilitation in Patients With Complicated Postoperative Recovery After Esophageal Cancer Surgery: Feasibility Study. J Med Internet Res. 2020 Jun 9;22(6):e16056. doi: 10.2196/16056.
PubMed 32515742Galiano-Castillo N, Arroyo-Morales M, Lozano-Lozano M, Fernandez-Lao C, Martin-Martin L, Del-Moral-Avila R, Cantarero-Villanueva I. Effect of an Internet-based telehealth system on functional capacity and cognition in breast cancer survivors: a secondary analysis of a randomized controlled trial. Support Care Cancer. 2017 Nov;25(11):3551-3559. doi: 10.1007/s00520-017-3782-9. Epub 2017 Jun 22.
PubMed 28639097Cottrell MA, O'Leary SP, Swete-Kelly P, Elwell B, Hess S, Litchfield MA, McLoughlin I, Tweedy R, Raymer M, Hill AJ, Russell TG. Agreement between telehealth and in-person assessment of patients with chronic musculoskeletal conditions presenting to an advanced-practice physiotherapy screening clinic. Musculoskelet Sci Pract. 2018 Dec;38:99-105. doi: 10.1016/j.msksp.2018.09.014. Epub 2018 Oct 4.
PubMed 30366292Dhawan S, Andrews R, Kumar L, Wadhwa S, Shukla G. A Randomized Controlled Trial to Assess the Effectiveness of Muscle Strengthening and Balancing Exercises on Chemotherapy-Induced Peripheral Neuropathic Pain and Quality of Life Among Cancer Patients. Cancer Nurs. 2020 Jul/Aug;43(4):269-280. doi: 10.1097/NCC.0000000000000693.
PubMed 30888982Zhang YH, Hu HY, Xiong YC, Peng C, Hu L, Kong YZ, Wang YL, Guo JB, Bi S, Li TS, Ao LJ, Wang CH, Bai YL, Fang L, Ma C, Liao LR, Liu H, Zhu Y, Zhang ZJ, Liu CL, Fang GE, Wang XQ. Exercise for Neuropathic Pain: A Systematic Review and Expert Consensus. Front Med (Lausanne). 2021 Nov 24;8:756940. doi: 10.3389/fmed.2021.756940. eCollection 2021.
PubMed 34901069Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30.
PubMed 28963591Stubblefield MD, McNeely ML, Alfano CM, Mayer DK. A prospective surveillance model for physical rehabilitation of women with breast cancer: chemotherapy-induced peripheral neuropathy. Cancer. 2012 Apr 15;118(8 Suppl):2250-60. doi: 10.1002/cncr.27463.
PubMed 22488699Mols F, Beijers T, Vreugdenhil G, van de Poll-Franse L. Chemotherapy-induced peripheral neuropathy and its association with quality of life: a systematic review. Support Care Cancer. 2014 Aug;22(8):2261-9. doi: 10.1007/s00520-014-2255-7. Epub 2014 May 1.
PubMed 24789421Bahar-Ozdemir Y, Akyuz G, Kalkandelen M, Yumuk PF. The Effect of Therapeutic Exercises on Balance, Quality of Life, and Pain in Patients Who Were Receiving Neurotoxic Chemotherapy. Am J Phys Med Rehabil. 2020 Apr;99(4):291-299. doi: 10.1097/PHM.0000000000001324.
PubMed 31592877