ExercisePICNCT02871284
Prevention of Chemotherapy-Related Polyneuropathy Via Sensorimotor Exercise Training
A study testing Exercise in people with Exercise and Chemotherapy-induced Polyneuropathy, run by German Cancer Research Center at 1 site in Germany.
Trial summary
Chemotherapy-induced peripheral neurotoxicity (CIPN) as a side effect of chemotherapy negatively affects patients' quality of life and may lead to treatment disturbances. CIPN is frequently recorded in patients treated with alkylating platinum-based drugs, antitubulins including the taxanes and vinca alkaloids, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise, Chemotherapy-induced Polyneuropathy
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with cancer and assigned to receive a chemotherapeutic regimen containing at least one of the following agents:
- a platinum analog, e.g., cisplatin, carboplatin, oxaliplatin
- a vinca alkaloid, e.g., vincristine
- a taxane, e.g., paclitaxel, docetaxel
- suramin
- thalidomide or lenalidomide
- bortezomib
- Physical capability that allows the performance of the training program implemented within the experimental intervention or the control intervention arm
Who cannot join
- Known polyneuropathy of any kind or any polyneuropathic signs or symptoms at baseline
- Abnormal electroneurographic findings at baseline
- Known metastasis to the central or peripheral nervous system
- Any physical or mental handicap that would hamper the performance of the training program implemented within the intervention arms
- Family history positive for any hereditary polyneuropathy
- Known history of alcohol or illegal drug abuse or any constellation of lab values suggesting alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Chemotherapy-induced peripheral neurotoxicity (CIPN) as a side effect of chemotherapy negatively affects patients' quality of life and may lead to treatment disturbances. CIPN is frequently recorded in patients treated with alkylating platinum-based drugs, antitubulins including the taxanes and vinca alkaloids, and other drugs including suramin, thalidomide, lenalidomide and the proteasome inhibitor bortezomib, representing one of the most severe and potentially dose-limiting non-hematological toxic effects. Sufficient treatment options or preventive measures are lacking.
There is evidence that physical activity strategies are able to address existing CIPN symptoms and potentially increase quality of life in affected patients. CIPN symptoms involves restrictions of sensory and sometimes motor modalities, for example, deficits in plantar perception and dysfunction of postural control and one study in type II diabetes patients also suggested that structured exercise might have a preventive potential with regard to peripheral neuropathy incidence.
Based on these findings, we aim to investigate the preventive potential of a sensorimotor intervention vs. machine-based resistance training vs. usual care (wait-list control group) in a randomized controlled three-arm intervention trial among cancer patients undergoing chemotherapy with high risk for CIPN. On the basis of power calculations, the goal is to include 82 patients per intervention arm resulting in a total patients number to be enrolled of n=246. CIPN symptoms will be assessed objectively via comprehensive clinical and electrodiagnostic examinations (Total Neuropathy Scale; TNS-reduced) and subjectively via questionnaires (EORTC QLQ-CIPN20 \& FACT-GOG-Ntx, EORTC QLQ-C30). Additionally CIPN and the effectiveness of the selected interventions will be objectively evaluated by spectral analysis of Centre of Pressure (COP) variations. Further key secondary endpoints are: physical performance, sleep quality and chemotherapy compliance.
- Conditions
- Exercise, Chemotherapy-induced Polyneuropathy
- Being tested
- Exercise
- Keywords
- cancer, anticancer treatment, exercise, physical activity, sensorimotor training, chemotherapy-induced polyneuropathy
- Medical subject headings
- Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Sensorimotor training (EI) | Experimental | The participants of the experimental intervention arm will take part in a 45 minutes sensorimotor training class two times a week for a maximum of 24 weeks at the NCT (National Center for Tumor Diseases). Highly qualified exercise therapists will guide the class. Class size will be no bigger than 8 patients to ensure adequate individual supervision and guidance. Additionally, participants will be asked to perform one weekly 15 minutes home-based sessions without supervision. Participants who are not able to come to the NCT Heidelberg 2x/week will be offered a home-based sensorimotor program including the same exercises. At the beginning, participants will receive an appointment for an individual face-to-face counseling session at the NCT. During this appointment, the patient will receive an exercise manual for individualized home-based sensorimotor training and a practical introduction by the exercise therapist. Receives: Behavioral: Exercise |
| machine-based resistance training (AC) | Active comparator | Participants of the active control arm will receive machine-based resistance training. The supervised resistance exercise program will be undertaken twice weekly in small groups (not more than 12 people per group) of participants and will be guided by an exercise physiotherapist over a maximum of 24 weeks. All sessions will start with a warm-up and finish with a cool-down (comprising exercise on a cycle ergometer or treadmill at a relatively low intensity and stretching activities) and will take approximately 45 minutes. Additionally, participants will be asked to perform a weekly 15 minutes home-based resistance training session without supervision Receives: Behavioral: Exercise |
| usual care | No intervention | Participants will receive usual care with no additional exercise training or intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Neuropathy Scale (TNS)
The TNS is based on symptoms, signs and basic instrumental evaluations and provides a much larger range of scoring values (0 - 40) than common oncological toxicity scales such as the National Cancer Institute (NCI) Common Toxicity Criteria (ranging from 0 - 4, cf. http://ctep.cancer.gov/forms), thus allowing the severity of CIPN to be graded more precisely. The TNS has so far been used to assess the neurotoxicity of various CIPN-relevant chemotherapeutic agents, and its results are clearly correlated with the clinically relevant results of NCI Common Toxicity Criteria, Ajani's and Eastern Cooperative Oncology Group toxicity scales, which are commonly used by oncologists.28-32 Within the PIC-Study the TNS-reduced will the primary endpoint. The TNS-reduced score excludes QST (quantitative sensory testing) vibration testing resulting in a TNS scale from 0-36.
Measured: up to week 24 (and 3 & 6 month follow up)
Secondary outcomes (9)
Centre of Pressure (COP)
total COP displacement; mean velocity (anterior-posterior; medial-lateral) and frequency. This is just one assessement with various outcome variables
Measured: up to week 24 (and 3 & 6 month follow up)
Strength Performance
Isometric (in four different joint angle positions) and isokinetic (at 60° angle speed) muscle capacity is measured with the Isomed 2000® diagnostic module. The protocol includes testing of representative muscles groups for upper (elbow flexors/extensors) and lower extremity (knee extensors/flexors) and is currently well established in different ongoing and finished studies in our unit.
Measured: up to week 24
Cardiopulmonary Fitness
Maximal endurance performance (VO2peak) is measured by performing a maximal bicycle ergometer test (CPET) with a quasi-ramp protocol starting at 20 watts and increasing by 10 watts every minute until volitional exhaustion.
Measured: up to week 24 (and 3 & 6 month follow up)
EORTC QLQ-C30
QoL will be assessed with the validated 30-item self-assessment questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It includes five multi-item functional scales (physical, role, emotional, cognitive, and social function), three multi-item symptom scales (fatigue, pain, nausea/vomiting), and six single items assessing further symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) and financial difficulties.
Measured: up to week 24 (and 3 & 6 month follow up)
EORTC QLQ-CIPN20
The EORTC QLQ-CIPN20 is a 20-item quality of life questionnaire, which has been developed to elicit patients' experience of symptoms and functional limitations related to CIPN. The CIPN20 has three subscales: a sensory, motor, and autonomic subscale. In combination with the more classical, physician-based clinical rating scales, the CIPN20 should yield a more complete picture of the nature, frequency, and severity of CIPN in a wide range of oncology patient populations. This phase IV questionnaire has been field tested in a large international clinical trial and the data are currently being analyzed.
Measured: prior to each Chemotherapy cycle within the first 24 weeks (and 3 & 6 month follow up)
FACT-GOG-Ntx
The FACT-GOG-Ntx is an eleven-item scale that evaluates symptoms and concerns associated specifically with chemotherapy-induced peripheral neuropathy. The questionnaire has been validated, ranges from zero to 44 with higher scores indicating increased CIPN symptoms and has been used in various clinical trials.
Measured: prior to each Chemotherapy cycle within the first 24 weeks (and 3 & 6 month follow up)
Multidimensional Fatigue Inventory (MFI)
Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI) which is a 20-item, multidimensional self-assessment questionnaire that has been validated for a German-speaking population. It covers five different dimensions of fatigue (general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue). Scores are derived by summing the answers (five-stage scale) of the appropriate items. The MFI has been used to assess fatigue in a variety of cancer patient studies, and psychometric properties of this instrument have been classified as satisfying or good.
Measured: up to week 24 (and 3 & 6 month follow up)
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality and sleep problems will be assessed with the validated and frequently used Pittsburgh Sleep Quality Index
Measured: up to week 24 (and 3 & 6 month follow up)
Short QUestionnaire to ASsess Health-enhancing Physical Activity
Physical activity behavior (PA) in the domains of commuting activity, leisure time activities such as cycling, walking, and sports, household and occupational activity will be assessed via a standardized and validated questionnaire, the Short QUestionnaire to ASsess Health-enhancing PA (SQUASH) which has the advantage that it is short and easy to complete.
Measured: up to week 24 (and 3 & 6 month follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, National Center for Tumor Diseases, Heidelberg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871284
- Sponsor's protocol ID
- S-630/2015/PIC
- Acronym
- PIC
- Status last verified
- May 2020
- First submitted
- 6 May 2016
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Pooling Initiative with the STOP Trial
Publications
Muller J, Weiler M, Schneeweiss A, Haag GM, Steindorf K, Wick W, Wiskemann J. Preventive effect of sensorimotor exercise and resistance training on chemotherapy-induced peripheral neuropathy: a randomised-controlled trial. Br J Cancer. 2021 Sep;125(7):955-965. doi: 10.1038/s41416-021-01471-1. Epub 2021 Jul 5.
PubMed 34226683
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Chemotherapy-Related Polyneuropathy Via Sensorimotor Exercise Training
- ClinicalTrials.gov ID
- NCT02871284
- Acronym / sponsor ID
- PIC / S-630/2015/PIC
- Conditions
- Exercise, Chemotherapy-induced Polyneuropathy
- Keywords
- cancer, anticancer treatment, exercise, physical activity, sensorimotor training, chemotherapy-induced polyneuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, National Center for Tumor Diseases, Heidelberg
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chemotherapy-induced peripheral neurotoxicity (CIPN) as a side effect of chemotherapy negatively affects patients' quality of life and may lead to treatment disturbances. CIPN is frequently recorded in patients treated with alkylating platinum-based drugs, antitubulins including the taxanes and vinca alkaloids, and other drugs including suramin, thalidomide, lenalidomide and the proteasome inhibitor bortezomib, representing one of the most severe and potentially dose-limiting non-hematological toxic effects. Sufficient treatment options or preventive measures are lacking.
There is evidence that physical activity strategies are able to address existing CIPN symptoms and potentially increase quality of life in affected patients. CIPN symptoms involves restrictions of sensory and sometimes motor modalities, for example, deficits in plantar perception and dysfunction of postural control and one study in type II diabetes patients also suggested that structured exercise might have a preventive potential with regard to peripheral neuropathy incidence.
Based on these findings, we aim to investigate the preventive potential of a sensorimotor intervention vs. machine-based resistance training vs. usual care (wait-list control group) in a randomized controlled three-arm intervention trial among cancer patients undergoing chemotherapy with high risk for CIPN. On the basis of power calculations, the goal is to include 82 patients per intervention arm resulting in a total patients number to be enrolled of n=246. CIPN symptoms will be assessed objectively via comprehensive clinical and electrodiagnostic examinations (Total Neuropathy Scale; TNS-reduced) and subjectively via questionnaires (EORTC QLQ-CIPN20 \& FACT-GOG-Ntx, EORTC QLQ-C30). Additionally CIPN and the effectiveness of the selected interventions will be objectively evaluated by spectral analysis of Centre of Pressure (COP) variations. Further key secondary endpoints are: physical performance, sleep quality and chemotherapy compliance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sensorimotor training (EI) | Experimental | Behavioral: ExerciseThe participants of the experimental intervention arm will take part in a 45 minutes sensorimotor training class two times a week for a maximum of 24 weeks at the NCT (National Center for Tumor Diseases). Highly qualified exercise therapists will guide the class. Class size will be no bigger than 8 patients to ensure adequate individual supervision and guidance. Additionally, participants will be asked to perform one weekly 15 minutes home-based sessions without supervision. Participants who are not able to come to the NCT Heidelberg 2x/week will be offered a home-based sensorimotor program including the same exercises. At the beginning, participants will receive an appointment for an individual face-to-face counseling session at the NCT. During this appointment, the patient will receive an exercise manual for individualized home-based sensorimotor training and a practical introduction by the exercise therapist. |
| machine-based resistance training (AC) | Active comparator | Behavioral: ExerciseParticipants of the active control arm will receive machine-based resistance training. The supervised resistance exercise program will be undertaken twice weekly in small groups (not more than 12 people per group) of participants and will be guided by an exercise physiotherapist over a maximum of 24 weeks. All sessions will start with a warm-up and finish with a cool-down (comprising exercise on a cycle ergometer or treadmill at a relatively low intensity and stretching activities) and will take approximately 45 minutes. Additionally, participants will be asked to perform a weekly 15 minutes home-based resistance training session without supervision |
| usual care | No intervention | –Participants will receive usual care with no additional exercise training or intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosed with cancer and assigned to receive a chemotherapeutic regimen containing at least one of the following agents:
- a platinum analog, e.g., cisplatin, carboplatin, oxaliplatin
- a vinca alkaloid, e.g., vincristine
- a taxane, e.g., paclitaxel, docetaxel
- suramin
Key exclusion criteria (6 listed)
- Known polyneuropathy of any kind or any polyneuropathic signs or symptoms at baseline
- Abnormal electroneurographic findings at baseline
- Known metastasis to the central or peripheral nervous system
- Any physical or mental handicap that would hamper the performance of the training program implemented within the intervention arms
- Family history positive for any hereditary polyneuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise | Behavioural | Sensorimotor training (EI), machine-based resistance training (AC) |
Primary outcome
Total Neuropathy Scale (TNS)
Time frame: up to week 24 (and 3 & 6 month follow up)
The TNS is based on symptoms, signs and basic instrumental evaluations and provides a much larger range of scoring values (0 - 40) than common oncological toxicity scales such as the National Cancer Institute (NCI) Common Toxicity Criteria (ranging from 0 - 4, cf. http://ctep.cancer.gov/forms), thus allowing the severity of CIPN to be graded more precisely. The TNS has so far been used to assess the neurotoxicity of various CIPN-relevant chemotherapeutic agents, and its results are clearly correlated with the clinically relevant results of NCI Common Toxicity Criteria, Ajani's and Eastern Cooperative Oncology Group toxicity scales, which are commonly used by oncologists.28-32 Within the PIC-Study the TNS-reduced will the primary endpoint. The TNS-reduced score excludes QST (quantitative sensory testing) vibration testing resulting in a TNS scale from 0-36.
9 secondary outcomes
Centre of Pressure (COP)
Time frame: up to week 24 (and 3 & 6 month follow up)
Strength Performance
Time frame: up to week 24
Cardiopulmonary Fitness
Time frame: up to week 24 (and 3 & 6 month follow up)
EORTC QLQ-C30
Time frame: up to week 24 (and 3 & 6 month follow up)
EORTC QLQ-CIPN20
Time frame: prior to each Chemotherapy cycle within the first 24 weeks (and 3 & 6 month follow up)
FACT-GOG-Ntx
Time frame: prior to each Chemotherapy cycle within the first 24 weeks (and 3 & 6 month follow up)
Multidimensional Fatigue Inventory (MFI)
Time frame: up to week 24 (and 3 & 6 month follow up)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: up to week 24 (and 3 & 6 month follow up)
Short QUestionnaire to ASsess Health-enhancing Physical Activity
Time frame: up to week 24 (and 3 & 6 month follow up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Derived from this study: PubMed 34226683Muller J, Weiler M, Schneeweiss A, Haag GM, Steindorf K, Wick W, Wiskemann J. Preventive effect of sensorimotor exercise and resistance training on chemotherapy-induced peripheral neuropathy: a randomised-controlled trial. Br J Cancer. 2021 Sep;125(7):955-965. doi: 10.1038/s41416-021-01471-1. Epub 2021 Jul 5.
- Individual participant dataSharing planned: Yes. Pooling Initiative with the STOP Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Exercise and Chemotherapy-induced Polyneuropathy, run by German Cancer Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Neuropathy Scale (TNS) (time frame: up to week 24 (and 3 & 6 month follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02871284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.