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Trial record 3 of 42 for:    Malignant Hyperthermia 5

Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT (OTMA-RII)

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ClinicalTrials.gov Identifier: NCT02638051
Recruitment Status : Completed
First Posted : December 22, 2015
Results First Posted : March 28, 2016
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Galenic Research Institute Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Peritoneal Neoplasms
Ascites
Yang Deficiency
Yin Deficiency
Interventions Device: Modulated Electro-Hyperthermia (mEHT)
Dietary Supplement: TCM Herbal Decoction (Shi Pi)
Drug: IPCI (CDDP+5FU)
Enrollment 260
Recruitment Details 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.
Pre-assignment Details There was no any pre-assignment dropout or exclusion.
Arm/Group Title Study Group Control Group
Hide Arm/Group Description

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.

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).

Period Title: Overall Study
Started 130 130
Completed 130 130
Not Completed 0 0
Arm/Group Title Study Group Control Group Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 130 130 260
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 130 participants 260 participants
58.88  (12.43) 56.07  (15.38) 57.48  (14.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 130 participants 260 participants
Female
72
  55.4%
61
  46.9%
133
  51.2%
Male
58
  44.6%
69
  53.1%
127
  48.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 130 participants 130 participants 260 participants
130 130 260
Primary Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 130 participants 260 participants
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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 130 participants 260 participants
Lungs 23 20 43
Liver 32 35 67
Celiac lymph nodes 53 50 103
Bones 22 25 47
Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 130 participants 260 participants
I 0 0 0
II 0 0 0
III 66 76 142
IV 64 54 118
[1]
Measure Description: Peritoneal carcinomatosis itself is considered III stage; evidence of distant metastases means IV stage.
Karnofsky Performance Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 130 participants 260 participants
60 26 21 47
70 50 47 97
80 42 48 90
90 12 14 26
[1]
Measure Description:

KPS 90% - symptomatic patients with normal daily activity. KPS 80% - normal daily activity with effort. KPS 70% - limited daily activity (unable to work), complete self-care. KPS 60% - limited daily activity (unable to work), limited self-care (needs assistance), active >50% of daytime.

KPS <60% (Perforce inactive (sits or lies) ≥50% of daytime) excluded.

CDDP (Intraperitoneal Chemoinfusion) Dose Per Session  
Mean (Standard Deviation)
Unit of measure:  Mg
Number Analyzed 130 participants 130 participants 260 participants
0  (0) 49.63  (10.19) NA [1]   (NA)
[1]
CDDP applied in Control Group only, total result is not applicable
5-FU (Intraperitoneal Chemoinfusion) Dose Per Session  
Mean (Standard Deviation)
Unit of measure:  Mg/sqm
Number Analyzed 130 participants 130 participants 260 participants
0  (0) 548.5  (39.68) NA [1]   (NA)
[1]
5FU applied in Control Group only, total result is not applicable
Interventions  
Median (Full Range)
Unit of measure:  Sessions
Number Analyzed 130 participants 130 participants 260 participants
mEHT
14
(14 to 14)
0
(0 to 0)
NA [1] 
(NA to NA)
TCM
28
(28 to 28)
0
(0 to 0)
NA [2] 
(NA to NA)
IPCI
0
(0 to 0)
2
(2 to 2)
NA [3] 
(NA to NA)
[1]
mEHT applied in Study Group only, total result is not applicable
[2]
TCM applied in Study Group only, total result is not applicable
[3]
IPCI applied in Control Group only, total result is not applicable
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:

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.

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).

Overall Number of Participants Analyzed 130 130
Measure Type: Number
Unit of Measure: percentage of participants
77.7 63.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments Applies to "Objective Response Rate (ORR)"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0140
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Adverse Events Rate (AER)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:

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.

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).

Overall Number of Participants Analyzed 130 130
Measure Type: Number
Unit of Measure: participants
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
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments Applies to "All" Adverse Events rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments Applies to "Abdominal pain" rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments Applies to "Gastrointestinal reactions"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments Applies to "Damage of hepatic or renal function"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments Applies to "Bone marrow depression"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0215
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Quality of Life (QoL)
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:

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.

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).

Overall Number of Participants Analyzed 130 130
Measure Type: Number
Unit of Measure: percentage of participants
Better QoL (KPS IR) 49.2 32.3
No Change 40.8 52.3
Worse QoL 10 15.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments Applies to "Better QoL"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0053
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments Applies to "No Change"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0527
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Study Group, Control Group
Comments Applies to "Worse QoL"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 2 months
Adverse Event Reporting Description 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”.
 
Arm/Group Title Study Group Control Group
Hide Arm/Group Description

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.

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).

All-Cause Mortality
Study Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/130 (0.00%)      0/130 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/130 (2.31%)      16/130 (12.31%)    
Blood and lymphatic system disorders     
Bone marow depression  1  0/130 (0.00%)  0 6/130 (4.62%)  6
Gastrointestinal disorders     
Abdominal Pain  1  3/130 (2.31%)  3 5/130 (3.85%)  5
Gastrointestinal Reactions  1  0/130 (0.00%)  0 3/130 (2.31%)  3
Hepatobiliary disorders     
Damage of hepatic function  1  0/130 (0.00%)  0 1/130 (0.77%)  1
Renal and urinary disorders     
Damage of renal function  1  0/130 (0.00%)  0 1/130 (0.77%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
  • Absence of the detailed peritoneal carcinomatosis characteristics.
  • Absence of a survival analysis. These limitations are related to the restricted funding of the trial.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Clifford LK Pang, President of Clifford Hospital
Organization: Clifford Hospital
Phone: (8620) 34710038
EMail: cpang@cliffordgroup.com
Other Publications:
Layout table for additonal information
Responsible Party: Galenic Research Institute Ltd
ClinicalTrials.gov Identifier: NCT02638051     History of Changes
Other Study ID Numbers: OT-CH-PCMA-14
First Submitted: December 17, 2015
First Posted: December 22, 2015
Results First Submitted: December 23, 2015
Results First Posted: March 28, 2016
Last Update Posted: May 19, 2017