Trial Outcomes & Findings for Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT (NCT NCT02638051)
NCT ID: NCT02638051
Last Updated: 2017-05-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
260 participants
Primary outcome timeframe
8 weeks after start of treatment (4 weeks on completion of treatment)
Results posted on
2017-05-19
Participant Flow
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.
There was no any pre-assignment dropout or exclusion.
Participant milestones
| Measure |
Study Group
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.
Modulated Electro-Hyperthermia (mEHT): 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.
TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.
|
Control Group
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 was occluded. Administered biweekly during four weeks of the course, totally two times.
IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
130
|
|
Overall Study
COMPLETED
|
130
|
130
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT
Baseline characteristics by cohort
| Measure |
Study Group
n=130 Participants
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.
Modulated Electro-Hyperthermia (mEHT): 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.
TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.
|
Control Group
n=130 Participants
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.
IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.88 years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
56.07 years
STANDARD_DEVIATION 15.38 • n=7 Participants
|
57.48 years
STANDARD_DEVIATION 14.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
130 participants
n=5 Participants
|
130 participants
n=7 Participants
|
260 participants
n=5 Participants
|
|
Primary Disease
Gastric Cancer
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Primary Disease
Colon Cancer
|
34 participants
n=5 Participants
|
37 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Primary Disease
Rectal Cancer
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Primary Disease
Pancreatic Cancer
|
13 participants
n=5 Participants
|
8 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Primary Disease
Endometrial Cancer
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Primary Disease
Ovarian Cancer
|
11 participants
n=5 Participants
|
16 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Primary Disease
Liver Cancer
|
23 participants
n=5 Participants
|
25 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Metastases
Lungs
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Metastases
Liver
|
32 participants
n=5 Participants
|
35 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Metastases
Celiac lymph nodes
|
53 participants
n=5 Participants
|
50 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
Metastases
Bones
|
22 participants
n=5 Participants
|
25 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Stage
I
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Stage
II
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Stage
III
|
66 participants
n=5 Participants
|
76 participants
n=7 Participants
|
142 participants
n=5 Participants
|
|
Stage
IV
|
64 participants
n=5 Participants
|
54 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Karnofsky Performance Score
60
|
26 participants
n=5 Participants
|
21 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Karnofsky Performance Score
70
|
50 participants
n=5 Participants
|
47 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Karnofsky Performance Score
80
|
42 participants
n=5 Participants
|
48 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Karnofsky Performance Score
90
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
CDDP (Intraperitoneal Chemoinfusion) Dose Per Session
|
0 mg
STANDARD_DEVIATION 0 • n=5 Participants
|
49.63 mg
STANDARD_DEVIATION 10.19 • n=7 Participants
|
NA mg
STANDARD_DEVIATION NA • n=5 Participants
|
|
5-FU (Intraperitoneal Chemoinfusion) Dose Per Session
|
0 mg/sqm
STANDARD_DEVIATION 0 • n=5 Participants
|
548.5 mg/sqm
STANDARD_DEVIATION 39.68 • n=7 Participants
|
NA mg/sqm
STANDARD_DEVIATION NA • n=5 Participants
|
|
Interventions
mEHT
|
14 sessions
n=5 Participants
|
0 sessions
n=7 Participants
|
NA sessions
n=5 Participants
|
|
Interventions
TCM
|
28 sessions
n=5 Participants
|
0 sessions
n=7 Participants
|
NA sessions
n=5 Participants
|
|
Interventions
IPCI
|
0 sessions
n=5 Participants
|
2 sessions
n=7 Participants
|
NA sessions
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after start of treatment (4 weeks on completion of treatment)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.
Outcome measures
| Measure |
Study Group
n=130 Participants
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.
Modulated Electro-Hyperthermia (mEHT): 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.
TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.
|
Control Group
n=130 Participants
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.
IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
|
|---|---|---|
|
Objective Response Rate (ORR)
|
77.7 percentage of participants
|
63.8 percentage of participants
|
SECONDARY outcome
Timeframe: During 4 weeks of treatment course and 4 weeks after treatmentCommon 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.
Outcome measures
| Measure |
Study Group
n=130 Participants
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.
Modulated Electro-Hyperthermia (mEHT): 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.
TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.
|
Control Group
n=130 Participants
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.
IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
|
|---|---|---|
|
Adverse Events Rate (AER)
All
|
3 participants
|
16 participants
|
|
Adverse Events Rate (AER)
Abdominal pain (Gr. I)
|
3 participants
|
5 participants
|
|
Adverse Events Rate (AER)
Gastrointestinal Reactions (Gr. I)
|
0 participants
|
3 participants
|
|
Adverse Events Rate (AER)
Damage of hepatic or renal function (Gr. I)
|
0 participants
|
2 participants
|
|
Adverse Events Rate (AER)
Bone marrow depression (Gr. I)
|
0 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 8 weeks after start of treatment (4 weeks on completion of treatment)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%.
Outcome measures
| Measure |
Study Group
n=130 Participants
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.
Modulated Electro-Hyperthermia (mEHT): 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.
TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.
|
Control Group
n=130 Participants
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.
IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
|
|---|---|---|
|
Quality of Life (QoL)
No Change
|
40.8 percentage of participants
|
52.3 percentage of participants
|
|
Quality of Life (QoL)
Worse QoL
|
10 percentage of participants
|
15.4 percentage of participants
|
|
Quality of Life (QoL)
Better QoL (KPS IR)
|
49.2 percentage of participants
|
32.3 percentage of participants
|
Adverse Events
Study Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Group
n=130 participants at risk
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.
Modulated Electro-Hyperthermia (mEHT): 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.
TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.
|
Control Group
n=130 participants at risk
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.
IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
|
|---|---|---|
|
Blood and lymphatic system disorders
Bone marow depression
|
0.00%
0/130 • 2 months
The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".
|
4.6%
6/130 • Number of events 6 • 2 months
The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.3%
3/130 • Number of events 3 • 2 months
The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".
|
3.8%
5/130 • Number of events 5 • 2 months
The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".
|
|
Gastrointestinal disorders
Gastrointestinal Reactions
|
0.00%
0/130 • 2 months
The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".
|
2.3%
3/130 • Number of events 3 • 2 months
The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".
|
|
Hepatobiliary disorders
Damage of hepatic function
|
0.00%
0/130 • 2 months
The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".
|
0.77%
1/130 • Number of events 1 • 2 months
The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".
|
|
Renal and urinary disorders
Damage of renal function
|
0.00%
0/130 • 2 months
The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".
|
0.77%
1/130 • Number of events 1 • 2 months
The adverse events were accounted based on the objective data and voluntary testimonies of patients or through non-leading questions, and were timely recorded into the "Table of Adverse Events".
|
Additional Information
Prof. Clifford LK Pang, President of Clifford Hospital
Clifford Hospital
Phone: (8620) 34710038
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place