A Phase 2 interventional study of Modulated Electro-Hyperthermia (mEHT) and TCM Herbal Decoction (Shi Pi) in Peritoneal Neoplasms, Ascites and Yang Deficiency, sponsored by Galenic Research Institute Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-19.
Sponsored by Galenic Research Institute Ltd · Phase 2, Interventional, and Treatment
This trial studies efficacy and safety of combination of modulated electro-hyperthermia (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis with malignant ascites versus standard chemoinfusion (CDDP+5FU).
Conservative treatment of peritoneal carcinomatosis with malignant ascites (PCMA) is based on chemoinfusion with its inherent toxicity. There is a strong demand for a safe and non-toxic method of treatment of PCMA. The new technology of modulated electro-hyperthermia (mEHT) has proven efficacy in many advanced cancers with minimal side effects and synergy with Traditional Chinese Medicine (TCM). TCM has a long history of application at advanced cancer as a symptomatic treatment and enhancer of the general resistance of the organism. Shi Pi Decoction is supposed to be the optimum co-treatment of PCMA according to principles of TCM. Intraperitoneal chemoinfusion (IPCI) with cisplatin and fluorouracil is a widespread standard treatment of PCMA in China. This randomized II phase trial studies efficacy and safety of combination of mEHT with TCM in treatment of PCMA versus standard IPCI (CDDP+5FU).
366 studies on the registry are indexed under Peritoneal Neoplasms; 56 are open to participants now.
This study's enrollment of 260 is above the median of 45 across 293 interventional studies indexed under Peritoneal Neoplasms.
Browse Peritoneal Neoplasms studies →This is the only study on the registry with Galenic Research Institute Ltd as lead sponsor.
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Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.
Device: Modulated Electro-Hyperthermia (mEHT) · Dietary Supplement: TCM Herbal Decoction (Shi Pi)
IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.
Drug: IPCI (CDDP+5FU)
MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.
Also known as: Oncothermia
Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.
Also known as: Shi Pi Decoction
Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
Objective Response Rate (ORR)
Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR) WHO criteria of therapeutic effect evaluation at malignant ascites: * Complete Remission (CR): complete absorption of ascites with no obvious regeneration for more than 1 month. * Partial Remission (PR): more than 50% reduction of ascites, with obvious relief of abdominal distention, with maintenance of less than moderate volume of ascites under ultrasound detection for more than 1 month. * No Change (NC): less than 50% reduction of ascites, or no obvious reduction of ascites under ultrasound detection, or even increase of ascites, with obvious abdominal distention.
Time frame: 8 weeks after start of treatment (4 weeks on completion of treatment)
Adverse Events Rate (AER)
Common Terminology Criteria for Adverse Events (CTCAE) (v4.03: June 14, 2010) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health, National Cancer Institute.
Time frame: During 4 weeks of treatment course and 4 weeks after treatment
Quality of Life (QoL)
Karnofsky Performance Score Improvement Rate (KPS IR) * Improvement: increase of KPS for ≥10% after treatment. * Worsening: reduction of KPS for ≥10% after treatment. * NC: change of KPS for \<10%.
Time frame: 8 weeks after start of treatment (4 weeks on completion of treatment)
From January 3, 2014 to December 20, 2014, 260 patients were recruited in Clifford Hospital. They were randomly allocated in two groups with 130 patients in each group.
| Milestone | Study Group | Control Group |
|---|---|---|
| Started | 130 | 130 |
| Completed | 130 | 130 |
| Not completed | 0 | 0 |
Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR) WHO criteria of therapeutic effect evaluation at malignant ascites: * Complete Remission (CR): complete absorption of ascites with no obvious regeneration for more than 1 month. * Partial Remission (PR): more than 50% reduction of ascites, with obvious relief of abdominal distention, with maintenance of less than moderate volume of ascites under ultrasound detection for more than 1 month. * No Change (NC): less than 50% reduction of ascites, or no obvious reduction of ascites under ultrasound detection, or even increase of ascites, with obvious abdominal distention.
| percentage of participants | Study Group | Control Group |
|---|---|---|
| Objective Response Rate (ORR) | 77.7 | 63.8 |
Common Terminology Criteria for Adverse Events (CTCAE) (v4.03: June 14, 2010) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health, National Cancer Institute.
| participants | Study Group | Control Group |
|---|---|---|
| All | 3 | 16 |
| Abdominal pain (Gr. I) | 3 | 5 |
| Gastrointestinal Reactions (Gr. I) | 0 | 3 |
| Damage of hepatic or renal function (Gr. I) | 0 | 2 |
| Bone marrow depression (Gr. I) | 0 | 6 |
Karnofsky Performance Score Improvement Rate (KPS IR) * Improvement: increase of KPS for ≥10% after treatment. * Worsening: reduction of KPS for ≥10% after treatment. * NC: change of KPS for \<10%.
| percentage of participants | Study Group | Control Group |
|---|---|---|
| Better QoL (KPS IR) | 49.2 | 32.3 |
| No Change | 40.8 | 52.3 |
| Worse QoL | 10 | 15.4 |
Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Group | — | 0/130 (0%) | 3/130 (2.3%) |
| Control Group | — | 0/130 (0%) | 16/130 (12.3%) |
| Event | Study Group | Control Group |
|---|---|---|
| Bone marow depressionBlood and lymphatic system disorders | 0/130 | 6/130 |
| Abdominal PainGastrointestinal disorders | 3/130 | 5/130 |
| Gastrointestinal ReactionsGastrointestinal disorders | 0/130 | 3/130 |
| Damage of hepatic functionHepatobiliary disorders | 0/130 | 1/130 |
| Damage of renal functionRenal and urinary disorders | 0/130 | 1/130 |
| Age, Continuous(years) | Study Group | Control Group | Total |
|---|---|---|---|
| Mean | 58.88 ± 12.43 | 56.07 ± 15.38 | 57.48 ± 14.03 |
| Sex: Female, Male(Participants) | Study Group | Control Group | Total |
|---|---|---|---|
| Female | 72 | 61 | 133 |
| Male | 58 | 69 | 127 |
| Region of Enrollment(participants) | Study Group | Control Group | Total |
|---|---|---|---|
| China | 130 | 130 | 260 |
| Primary Disease(participants) | Study Group | Control Group | Total |
|---|---|---|---|
| Gastric Cancer | 22 | 24 | 46 |
| Colon Cancer | 34 | 37 | 71 |
| Rectal Cancer | 18 | 15 | 33 |
| Pancreatic Cancer | 13 | 8 | 21 |
| Endometrial Cancer | 9 | 5 | 14 |
| Ovarian Cancer | 11 | 16 | 27 |
| Liver Cancer | 23 | 25 | 48 |
| Metastases(participants) | Study Group | Control Group | Total |
|---|---|---|---|
| Lungs | 23 | 20 | 43 |
| Liver | 32 | 35 | 67 |
| Celiac lymph nodes | 53 | 50 | 103 |
| Bones | 22 | 25 | 47 |
| Stage(participants) | Study Group | Control Group | Total |
|---|---|---|---|
| I | 0 | 0 | 0 |
| II | 0 | 0 | 0 |
| III | 66 | 76 | 142 |
| IV | 64 | 54 | 118 |
| Karnofsky Performance Score(participants) | Study Group | Control Group | Total |
|---|---|---|---|
| 60 | 26 | 21 | 47 |
| 70 | 50 | 47 | 97 |
| 80 | 42 | 48 | 90 |
| 90 | 12 | 14 | 26 |
| CDDP (Intraperitoneal Chemoinfusion) Dose Per Session(mg) | Study Group | Control Group | Total |
|---|---|---|---|
| Mean | 0 ± 0 | 49.63 ± 10.19 | NA ± NA |
2 further baseline measures are reported on the registry.
Plan to share: No
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