Transcutaneous pulsed radiofrequency (tPRF) may affect tumor activities.
ID
Bron
Verkorte titel
Aandoening
- Metastasen
Aandoening
Advanced-stage colorectal, breast, prostate, or ovarian cancer no longer responding to systemic treatment
Betreft onderzoek met
Ondersteuning
Springlife Medical B.V.
Nederlandse Stichting Pijnbestrijding
Onderzoeksproduct en/of interventie
- Overige
Uitkomstmaten
Primaire uitkomstmaten
Tumor markers
- Carcinoembryonic antigen (CEA) for colorectal cancer;
- Carcinoma antigen 15.3 (CA15.3) for breast cancer;
- Prostate-specific antigen(PSA) for prostate cancer:
- Carcinoma antigen 125 (CA125) for ovarian cancer.
Achtergrond van het onderzoek
Rationale: Pulsed radiofrequency (PRF) is widely used for pain relief. The working mechanism is still under discussion, and the hypothesis is that PRF may affect the reactivity of immune cells. Immune cells play essential roles in tumor progression and tumor growth, and these tumor activities can be indicated by tumor markers. In this study we focus on cancer patients receiving standard palliative treatment and explore the effect of transcutaneous PRF (tPRF) on their tumor marker.
Objective: To study the effect of tPRF on a specific tumor marker in patients with advanced-stage cancer.
Study design: The proposed study is a single-centered, open-label, single-arm proof of concept study.
Study population: Patients with advanced-stage colorectal, breast, prostate, or ovarian cancer no longer responding to systemic treatment in Radboud UMC, and no other standard oncological treatment can be applied anymore, receiving standard palliative care, with history of tumor marker responding to disease progression and previous oncological treatment, with aged ≥ 18 years old are asked to participate.
Intervention: Participating patients will be treated with tPRF for at least two times during their regular palliative-care related hospital visiting,
Main study parameters/endpoints: Tumor marker.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
• Burden: This study has a very low burden for the participants. Study visits (three to four times) are scheduled into patients’ regular palliative-care related hospital visits. tPRF treatment is applied two to three times; pain intensity and quality of life are assessed in each visiting; two blood samples are taken in two separate days (during the first and the last visiting). Besides these, there is no difference compared to standard palliative treatment.
• Risks: This study has a very low risk for the participants. tPRF is a non-invasive, painless treatment. It has been used as a pain-relief procedure with no known complications or side effects.
• Benefit: It is unknown if participants can benefit from the study.
• Group relatedness: Participating patients do not get any oncologic treatment anymore and their tumor markers keep on increasing. In the meantime, these patients visit Radboud UMC regularly for consultation on palliative care.
Doel van het onderzoek
Transcutaneous pulsed radiofrequency (tPRF) may affect tumor activities.
Onderzoeksopzet
Baseline, 2 weeks, 4 weeks, 6 weeks
Onderzoeksproduct en/of interventie
Transcutaneous pulsed radiofrequency
Publiek
Junzeng Fu
Kaap de Goede Hooplaan 7
Utrecht 3526 AR
The Netherlands
+31(0)623795039
junzeng.fu@radboudumc.nl
Wetenschappelijk
Junzeng Fu
Kaap de Goede Hooplaan 7
Utrecht 3526 AR
The Netherlands
+31(0)623795039
junzeng.fu@radboudumc.nl
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1) ≥ 18 years of age;
2) patients with advanced-stage colorectal, breast, prostate or ovarian cancer;
3) presently no longer responding to systemic treatment, and no other standard oncological treatment can be applied anymore (i.e. a patient is strictly in a clear palliative trajectory).
4) history of tumor marker corresponding with disease progression on imaging;
5) history of tumor marker responding to previous oncological treatment;
6) patients able and willing to give written informed consent and comply with the requirement of the study protocol;
7) life expectancy at least 3 months.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1) treatment with any cancer therapy, including but not limited to chemotherapy and radiation therapy, within 4 weeks before baseline;
2) in the use of critical measuring devices, large metal implants or active implants like a pacemaker;
3) pregnant.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
p/a Radboudumc, huispost 628,
Postbus 9101
6500 HB Nijmegen
024 361 3154
commissiemensgebondenonderzoek@radboudumc.nl
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In overige registers
Register | ID |
---|---|
NTR-new | NL7234 |
NTR-old | NTR7433 |
CCMO | NL62615.091.17 |
OMON | NL-OMON46593 |